388 
(A) reduce expenditures under the Medi-
care program under title XVIII of the Social 
Security Act; or 
(B) do not increase expenditures under the 
Medicare program and reduce racial and ethnic 
health disparities in the quality of health care 
services provided to target individuals and in-
crease satisfaction of beneficiaries and health 
care providers; 
the Secretary shall continue the existing demonstra-
tion projects and may expand the number of dem-
onstration projects. 
(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) CONTENTS OF REPORT.—Each report under 
paragraph (1) shall include the following: 
(A) A description of the demonstration 
projects. 
(B) An evaluation of— 
(i) the cost effectiveness of the dem-
onstration projects; 
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(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 to such extent and for such period as 
the Secretary determines is necessary to conduct dem-
onstration projects. 
SEC. 705. 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-
tion referred to as the ‘‘Secretary’’) shall enter into 
an agreement with the National Quality Forum 
under which the National Quality Forum shall de-
velop a uniform set of measures to evaluate dispari-
ties in the quality of cancer care, endorse such set 
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of measures through its multistakeholder consensus 
development process, 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 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 re-
porting period through use of the measures devel-
oped pursuant to subsection (a). Such data shall be 
submitted in a form and manner and at a time spec-
ified by the Secretary. 
(2) SPECIFICATION OF PROVIDERS TO REPORT 
ON
MEASURES.—The Secretary shall specify the 
classes of Medicare providers of services and sup-
pliers, including hospitals, cancer centers, physi-
cians, primary care providers, and specialty pro-
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viders, that will be required under such process to 
publicly report on the measures specified under sub-
section (a). 
(3) ASSESSMENT OF CHANGES.—Within this re-
porting process, the Secretary shall also establish a 
format that assesses changes in both the absolute 
and relative disparities over time. These measures 
shall be presented in an easily comprehensible for-
mat, such as those presented in the final publica-
tions relating to Healthy People 2010 or the Na-
tional 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 2011’’. 
(b) FINDINGS.—Congress finds the following: 
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(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 
in this country. It is the most common cause of 
chronic liver disease, liver cirrhosis, and the most 
common indication for liver transplantation. It is 
also a leading cause of death in Americans living 
with HIV/AIDS, many of whom are coinfected with 
chronic HBV, chronic HCV, or both. At least 15,000 
deaths per year in the United States can be attrib-
uted to chronic HBV and HCV. 
(3) According to the Centers for Disease Con-
trol and Prevention (referred to in this section as 
the ‘‘CDC’’ ‘‘’’), approximately 2 percent of the pop-
ulation 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. 
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(4) HBV is easily transmitted and is 100 times 
more infectious than HIV. According to the CDC, 
HBV is transmitted through percutaneous (i.e., 
puncture through the skin) or mucosal contact with 
infectious blood or body fluids. HCV is transmitted 
by percutaneous exposures to infectious blood. 
(5) The CDC conservatively estimates that in 
2008 approximately 18,000 Americans were newly 
infected with HCV and more than 38,000 Americans 
were newly infected with HBV. 
(6) There were 6 outbreaks reported to CDC 
for investigation in 2008 related to health care ac-
quired infection of HBV and HCV, potentially ex-
posing more than 52,000 Americans to the viruses, 
in 2009–2010 there were 15 outbreaks in which 
more than 30,000 people were potentially exposed. 
(7) 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, more than 50 percent of infected individuals 
will develop cirrhosis, end-stage liver disease, or liver 
cancer. Since most of those with chronic HBV and 
HCV are unaware of their infection, they do not 
know to take precautions to prevent the spread of 
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their infection and can unknowingly exacerbate their 
own disease progression. 
(8) HBV and HCV disproportionately affect 
certain populations in the United States. Although 
representing only 5 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 1946 and 1964) 
account for more than half of domestic chronic hepa-
titis C cases. In addition, African-Americans, Latin- 
Americans, and American Indian/Alaskan Natives 
are among the groups which have disproportionately 
high rates of HBV and/or HCV infections in the 
United States. 
(9) 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. 
(10) For those chronically infected with HBV 
or HCV, regular monitoring can lead to the early de-
tection of liver cancer at a stage where cure is still 
possible. Liver cancer is the third deadliest cancer in 
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the United States however, liver cancer has received 
little funding for research, prevention, or treatment. 
(11) Treatment for chronic HCV can eradicate 
the disease in approximately 75 percent of those cur-
rently treated. The treatment of chronic HBV can 
effectively suppress viral replication in the over-
whelming majority (>80%) of those treated 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. 
(12) To combat the HBV and HCV epidemics 
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 National 
Academies 2010 reported on the Federal response to 
HBV and HCV titled: Hepatitis and Liver Cancer: 
A National Strategy for Prevention and Control of 
Hepatitis B and C. These recommendations and 
guidelines provide a framework for HBV and HCV 
prevention, education, control, research, and medical 
management programs. 
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(13) 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 
$1,000,000,000 to 2,000,000,000 ($1,000 to $2,000 
per infected person). More than $1,000,000,000 is 
spent each year for HBV-related hospitalizations. 
The indirect costs of chronic HBV infection are 
harder to measure, but include reduced physical and 
emotional quality of life, reduced economic produc-
tivity, long-term disability, and premature death. 
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 diagnosing individuals earlier—and 
connecting them to appropriate treatment and care 
will save lives and critical health care dollars. Cur-
rently, without a comprehensive screening, testing 
and diagnosis program, 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 the Federal Government invests in effective 
mechanisms to avoid documented cost drivers. 
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(14) According to the IOM 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. 
(15) Screening and testing for HBV and HCV 
is aligned with the Healthy People 2020 goal; 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. 
(16) 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. 
(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— 
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(1) by striking section 317N (42 U.S.C. 247b– 
15); and 
(2) by adding at the end the following: 
‘‘PART X—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 
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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. 
‘‘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 
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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 
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 
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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 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 
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‘‘(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 (2) 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 dis-
eases, and substance abuse, and programs for indi-
viduals in correctional settings). 
‘‘(2) 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. 
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‘‘(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. 
‘‘(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 
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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 
‘‘(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 language appropriate health 
information, such as how to prevent hepa-
titis B perinatal infection, and to alleviate 
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 
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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-
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; 
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‘‘(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 
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 
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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 
drug and alcohol abuse treatment where 
appropriate. 
‘‘(3) INCREASED SUPPORT FOR ADULT VIRAL 
HEPATITIS COORDINATORS.—The Secretary, acting 
through the Director of the Centers for Disease 
Control and Prevention, shall provide increased sup-
port to Adult Viral Hepatitis Coordinators in State, 
local, territorial, and tribal health departments in 
order to enhance the additional management, net-
working, 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.— 
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‘‘(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-
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 
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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 
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 
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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-
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. 
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‘‘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. 
‘‘SEC. 399NN–3. AUTHORIZATION OF APPROPRIATIONS. 
‘‘There are authorized to be appropriated to carry out 
this part $90,000,000 for fiscal year 2012, $90,000,000 
for fiscal year 2013, $110,000,000 for fiscal year 2014, 
$130,000,000 for fiscal year 2015, and $150,000,000 for 
fiscal year 2016.’’. 
(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’’. 
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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 2011’’. 
(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. 
(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 
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minority populations, particularly in Asian-American 
and Hispanic/Latin-American 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. 
(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. 
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(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-
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). 
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‘‘(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-
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 
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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-
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 
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‘‘(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. 
‘‘(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— 
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‘‘(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 2012 through 2016.’’. 
(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-
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-
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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 2012 
through 2016. 
(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: 
‘‘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-
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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 sup-
ported under section 1707(b)(8) (including by means 
of the center’s Web site, through appropriate loca-
tions 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 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-
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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 
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. 
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