I 
110TH CONGRESS 
1ST SESSION H. R. 3368 
To amend the Public Health Service Act to establish a pulmonary hyper-
tension clinical research network, to expand pulmonary hypertension re-
search and training, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
AUGUST 3, 2007 
Mr. LANTOS (for himself and Mr. BRADY of Texas) introduced the following 
bill; which was referred to the Committee on Energy and Commerce, and 
in addition to the Committee on Ways and Means, for a period to be sub-
sequently determined by the Speaker, in each case for consideration of 
such provisions as fall within the jurisdiction of the committee concerned 
A BILL 
To amend the Public Health Service Act to establish a pul-
monary hypertension clinical research network, to expand 
pulmonary hypertension research and training, and for 
other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Pulmonary Hyper-
tension Research and Education Act of 2007’’. 
SEC. 2. FINDINGS. 
The Congress finds as follows: 
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(1) Pulmonary hypertension is a serious and 
often fatal condition where the blood pressure in the 
lungs rises to dangerously high levels. In pulmonary 
hypertension patients, the walls of the arteries that 
take blood from the right side of the heart to the 
lungs thicken and constrict. As a result, the right 
side of the heart has to pump harder to move blood 
into the lungs, causing it to enlarge and ultimately 
fail. 
(2) In order to take full advantage of the tre-
mendous potential for finding a cure or effective 
treatment, the Federal investment in pulmonary hy-
pertension must be expanded, and collaboration 
among top pulmonary hypertension research centers 
must be increased. 
(3) Pulmonary hypertension remains a difficult 
diagnosis and is rarely picked up in a routine med-
ical examination. Even in its later stages, the signs 
of the disease can be confused with other conditions 
affecting the heart and lungs. The use of new diag-
nostic standards has been positively related to the 
rates of diagnosis. 
(4) In the more advanced stages of pulmonary 
hypertension, the patient is able to perform only 
minimal activity and has symptoms even when rest-
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ing, resulting in considerable disability. The disease 
may worsen to the point where the patient is com-
pletely bedridden. 
(5) In 1981, the National Heart, Lung, and 
Blood Institute established the first pulmonary hy-
pertension patient registry in the world. The registry 
followed 194 people with pulmonary hypertension 
over a period of at least one year and, in some cases, 
more than seven years. Much of what is known 
about the illness today stems from this study. 
(6) Because the cause of pulmonary hyper-
tension is still not fully understood and there is still 
not a cure for pulmonary hypertension, basic re-
search studies are focusing on the possible involve-
ment of immunologic and genetic factors in the 
cause and progression of pulmonary hypertension, 
looking at agents that cause narrowing of the pul-
monary blood vessels, and identifying factors that 
cause growth of endothelial and smooth muscle cells, 
and formation of scar tissue in the vessel walls. 
(7) As research progresses, so do treatments for 
pulmonary hypertension. Currently, there are six 
FDA-approved medications for pulmonary hyper-
tension and several more in trials. However, not all 
medications are effective in all patients. In addition, 
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all pulmonary hypertension treatments have signifi-
cant negative side effects that impact patients’ qual-
ity of life. Lung transplantation is often considered 
a treatment of last resort for pulmonary hyper-
tension. 
(8) The number of physicians who treat pul-
monary hypertension, and the number of pulmonary 
hypertension patients receiving treatment, has grown 
exponentially over the past decade, leading to the 
need for increased education of medical profes-
sionals. In 2001, there were 100 identified physi-
cians treating pulmonary hypertension, and 3,000 
patients receiving treatment. In 2006, there were an 
estimated 3,000 such physicians and 30,000 such 
patients. While pulmonary hypertension treatment 
now includes the option of relatively easy to admin-
ister oral therapies, effective management of pul-
monary hypertension remains complicated. Given the 
increase in the number of physicians treating pul-
monary hypertension, education of medical profes-
sionals about pulmonary hypertension management 
is critical to ensure optimal patient care. 
(9) In December 2006, the National Heart, 
Lung, and Blood Institute hosted a landmark meet-
ing of pulmonary hypertension researchers and clini-
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cians throughout the world. Over 500 individuals at-
tended, making this the largest such meeting orga-
nized by a Federal department for this disease. Dur-
ing the meeting, there was clear consensus that com-
munication among researchers is key to future ad-
vancement in the fight against this devastating and 
expensive disease. 
SEC. 3. PULMONARY HYPERTENSION CLINICAL RESEARCH 
NETWORK; EXPANSION OF PULMONARY HY-
PERTENSION RESEARCH AND TRAINING. 
Subpart 2 of part C of title IV of the Public Health 
Service Act (42 U.S.C. 285b et seq.) is amended by insert-
ing after section 424B the following section: 
‘‘PULMONARY HYPERTENSION 
‘‘SEC. 424C. 
‘‘(a) IN GENERAL.—The Director of the Institute 
shall expand, intensify, and coordinate the activities of the 
Institute with respect to research on pulmonary hyper-
tension. 
‘‘(b) ESTABLISHMENT
OF
PULMONARY
HYPER-
TENSION CLINICAL RESEARCH NETWORK.— 
‘‘(1) Not later than one year after the date of 
the enactment of this section, the Director of the In-
stitute shall establish a Pulmonary Hypertension 
Clinical Research Network (in this section referred 
to as the ‘network’). The purpose of the network 
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shall be to conduct multiple clinical trials to evaluate 
new treatment approaches for pulmonary hyper-
tension and facilitate collaboration among investiga-
tors with expertise in pulmonary hypertension. The 
network shall consist of the following: 
‘‘(A) No fewer than 15 clinical centers des-
ignated by the Director. 
‘‘(B) An institute project scientist, as de-
fined and appointed by the Director. 
‘‘(C) A data and coordinating center, as 
defined and appointed by the Director. 
‘‘(D) A data and safety monitoring board, 
as defined and appointed by the Director. 
‘‘(E) A steering committee comprised of 
the principal investigators from each clinical 
center described under subparagraph (A), the 
data and coordinating center described in sub-
paragraph (C), and the institute project sci-
entist described in subparagraph (B). 
‘‘(F) An independent protocol review com-
mittee, as defined and appointed by the Direc-
tor. 
‘‘(2) STEERING
COMMITTEE.—The steering 
committee described in paragraph (1)(E) shall deter-
mine the specific clinical trials to be performed 
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under this section, establish standards for subject 
selection and characterization for such trials, develop 
detailed protocols for such trials, and analyze and 
publish the results of such trials. Possible clinical 
trials shall include: 
‘‘(A) Combination therapies for pulmonary 
hypertension. 
‘‘(B) New avenues of drug therapy based 
on recognized cellular defects in pulmonary hy-
pertension that are not impacted by current 
treatment. 
‘‘(C) Use of endothelial progenitor cells for 
replacement of abnormal pulmonary vascular 
cells in pulmonary hypertension. 
‘‘(D) Discovery of treatment effects which 
are most predictive of long-term outcome. 
‘‘(3) 
PROGRAM
MANAGEMENT; 
APPOINT-
MENTS.— 
‘‘(A) IN GENERAL.—The Institute shall be 
responsible for organizing and providing sup-
port for the network. 
‘‘(B) INSTITUTE
PROJECT
SCIENTIST.— 
The institute project scientist appointed under 
paragraph (1)(B) shall— 
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‘‘(i) monitor the recruitment of sub-
jects for the trials and the progress of the 
trials; 
‘‘(ii) ensure disclosure of conflicts of 
interest and adherence of the conduct of 
the clinical trials to the policies of the In-
stitute; and 
‘‘(iii) conduct, with the institute 
grants management specialist described in 
subparagraph (C), the fiscal management 
of the network. 
‘‘(C) 
INSTITUTE
MANAGEMENT
SPE-
CIALIST.—An institute grants management spe-
cialist (as defined and appointed by the Direc-
tor) shall assist the institute project scientist in 
conducting the fiscal management of the net-
work under subparagraph (B)(iii). 
‘‘(D) ADDITIONAL
APPOINTMENTS.—The 
Director shall appoint the Chair of the steering 
committee described in paragraph (1)(E) and 
all members of the protocol review committee 
under paragraph (1)(F) and the data safety 
monitoring board under paragraph (1)(D). 
‘‘(c) PULMONARY HYPERTENSION PRECEPTORSHIP 
AND TRAINING PROGRAM.— 
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‘‘(1) IN GENERAL.—Not later than one year 
after the date of the enactment of this section, the 
Director of the Institute shall carry out a grant pro-
gram under which the Director makes a grant to (or 
enters into a contract with) a national nonprofit en-
tity with expertise in pulmonary hypertension to es-
tablish and administer a national Pulmonary Hyper-
tension Preceptorship and Training Program (in this 
section referred to as the ‘program’). 
‘‘(2) PURPOSE.—The program shall facilitate 
the direct education and training of medical profes-
sionals 
(including 
cardiologists, 
pulmonologists, 
rheumatologists, and primary care physicians) by ex-
perienced pulmonary hypertension specialists in clin-
ical settings. The purpose of the program is to in-
crease the number of physicians in the United States 
trained to effectively diagnosis, treat, and manage 
pulmonary hypertension. 
‘‘(3) REGIONAL TRAINING SITES.—To carry out 
the purpose of the program described in paragraph 
(2), the entity awarded the grant (or contract) under 
paragraph (1) shall under the program facilitate the 
creation of no fewer than five regional training sites 
across the United States at academic health centers, 
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hospitals, or private medical practices recognized for 
their expertise in pulmonary hypertension. 
‘‘(4) REGIONAL
SITE
CONTACTS.—Under the 
program— 
‘‘(A) each regional training site shall iden-
tify a site contact; and 
‘‘(B) the Director shall specify a percent-
age of the grant funds required to be allocated 
for purposes of providing each such site contact 
with a stipend. 
‘‘(5) PARTICIPANT
RECRUITMENT
AND
PRO-
GRAM GUIDELINES.—The nonprofit entity awarded 
the grant (or contract) under paragraph (1) shall es-
tablish mechanisms for identifying and enrolling in-
terested health professionals in the program. The 
nonprofit entity shall also work with the regional 
training sites under paragraph (3) and the Institute 
to establish model guidelines for the program. 
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—For the 
purpose of carrying out this section, there are authorized 
to be appropriated such sums as may be necessary for 
each of the fiscal years 2009 through 2012.’’. 
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SEC. 4. INCREASING PUBLIC AWARENESS OF PULMONARY 
HYPERTENSION. 
(a) PULMONARY HYPERTENSION EDUCATION PRO-
GRAM.—The Secretary of Health and Human Services, 
acting through the Director of the Centers for Disease 
Control and Prevention, shall develop and disseminate to 
the public information regarding pulmonary hypertension, 
including materials on— 
(1) basic information on pulmonary hyper-
tension and its symptoms; 
(2) the incidence and prevalence of pulmonary 
hypertension; 
(3) diseases and conditions that can lead to pul-
monary hypertension as a secondary diagnosis; 
(4) the importance of early diagnosis; and 
(5) the availability, as medically appropriate, of 
a range of treatment options and pulmonary hyper-
tension. 
(b) DISSEMINATION
OF INFORMATION.—The Sec-
retary of Health and Human Services shall disseminate 
information under subsection (a) through arrangements 
with a national non-profit entity with expertise in pul-
monary hypertension. 
(c) AUTHORIZATION OF APPROPRIATIONS.—For the 
purpose of carrying out this section, there are authorized 
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to be appropriated such sums as may be necessary for 
each of the fiscal years 2009 through 2012. 
SEC. 5. DISSEMINATION OF INFORMATION TO HEALTH 
PROFESSIONALS 
ON 
PULMONARY 
HYPER-
TENSION. 
(a) DISSEMINATION
OF INFORMATION.—The Sec-
retary of Health and Human Services, acting through the 
Administrator of the Health Resources and Services Ad-
ministration and the Director of the Centers for Disease 
Control and Prevention, shall develop and disseminate to 
health care providers information on pulmonary hyper-
tension for the purpose of ensuring that providers remain 
informed about the disease, its presenting symptoms, and 
current treatment options. Such information shall include 
material on the warning signs of pulmonary hypertension, 
the importance of early diagnosis, diagnostic criteria, and 
therapies approved by the Food and Drug Administration 
for the disease. Such health care providers shall include 
cardiologists, pulmonologists, rheumatologists, primary 
care physicians, pediatricians, and nurse practitioners. 
(b) DISSEMINATION
OF INFORMATION.—The Sec-
retary of Health and Human Services shall disseminate 
information under subsection (a) through arrangements 
with a national non-profit entity with expertise in pul-
monary hypertension. 
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(c) AUTHORIZATION OF APPROPRIATIONS.—For the 
purpose of carrying out this section, there are authorized 
to be appropriated such sums as may be necessary for 
each of the fiscal years 2009 through 2012. 
SEC. 6 STUDY BY GOVERNMENT ACCOUNTABILITY OFFICE 
ON MEDICARE AND MEDICAID COVERAGE 
STANDARDS. 
(a) IN GENERAL.—The Comptroller General of the 
United States shall conduct a study on the coverage stand-
ards that, under the Medicare program under title XVIII 
of the Social Security Act and the Medicaid program 
under title XIX of such Act, apply to individuals with pul-
monary hypertension. The study shall detail coverage 
standards under such programs for all therapies approved 
by the Food and Drug Administration for the treatment 
of pulmonary hypertension. The study shall take into ac-
count appropriate outpatient or home health care delivery 
settings for delivery of such services. 
(b) REPORT.—Not later than six months after the 
date of the enactment of this Act, the Comptroller General 
shall submit to Congress a report describing the findings 
of the study under subsection (a). 
Æ 
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