[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3368 Introduced in House (IH)]







110th CONGRESS
  1st Session
                                H. R. 3368

    To amend the Public Health Service Act to establish a pulmonary 
      hypertension clinical research network, to expand pulmonary 
      hypertension research 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 subsequently 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 pulmonary 
      hypertension clinical research network, to expand pulmonary 
      hypertension research and training, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Pulmonary Hypertension Research and 
Education Act of 2007''.

SEC. 2. FINDINGS.

    The Congress finds as follows:
            (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 tremendous 
        potential for finding a cure or effective treatment, the 
        Federal investment in pulmonary hypertension 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 medical 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 diagnostic 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 resting, resulting in considerable 
        disability. The disease may worsen to the point where the 
        patient is completely bedridden.
            (5) In 1981, the National Heart, Lung, and Blood Institute 
        established the first pulmonary hypertension 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 hypertension is still 
        not fully understood and there is still not a cure for 
        pulmonary hypertension, basic research studies are focusing on 
        the possible involvement of immunologic and genetic factors in 
        the cause and progression of pulmonary hypertension, looking at 
        agents that cause narrowing of the pulmonary 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 hypertension and several more in trials. However, 
        not all medications are effective in all patients. In addition, 
        all pulmonary hypertension treatments have significant negative 
        side effects that impact patients' quality of life. Lung 
        transplantation is often considered a treatment of last resort 
        for pulmonary hypertension.
            (8) The number of physicians who treat pulmonary 
        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 
        professionals. In 2001, there were 100 identified physicians 
        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 administer oral therapies, effective management of 
        pulmonary hypertension remains complicated. Given the increase 
        in the number of physicians treating pulmonary hypertension, 
        education of medical professionals 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 meeting of pulmonary hypertension 
        researchers and clinicians throughout the world. Over 500 
        individuals attended, making this the largest such meeting 
        organized by a Federal department for this disease. During the 
        meeting, there was clear consensus that communication among 
        researchers is key to future advancement in the fight against 
        this devastating and expensive disease.

SEC. 3. PULMONARY HYPERTENSION CLINICAL RESEARCH NETWORK; EXPANSION OF 
              PULMONARY HYPERTENSION 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 inserting 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 hypertension.
    ``(b) Establishment of Pulmonary Hypertension Clinical Research 
Network.--
            ``(1) Not later than one year after the date of the 
        enactment of this section, the Director of the Institute shall 
        establish a Pulmonary Hypertension Clinical Research Network 
        (in this section referred to as the `network'). The purpose of 
        the network shall be to conduct multiple clinical trials to 
        evaluate new treatment approaches for pulmonary hypertension 
        and facilitate collaboration among investigators with expertise 
        in pulmonary hypertension. The network shall consist of the 
        following:
                    ``(A) No fewer than 15 clinical centers designated 
                by the Director.
                    ``(B) An institute project scientist, as defined 
                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 subparagraph (C), and 
                the institute project scientist described in 
                subparagraph (B).
                    ``(F) An independent protocol review committee, as 
                defined and appointed by the Director.
            ``(2) Steering committee.--The steering committee described 
        in paragraph (1)(E) shall determine the specific clinical 
        trials to be performed 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 hypertension 
                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; appointments.--
                    ``(A) In general.--The Institute shall be 
                responsible for organizing and providing support for 
                the network.
                    ``(B) Institute project scientist.--The institute 
                project scientist appointed under paragraph (1)(B) 
                shall--
                            ``(i) monitor the recruitment of subjects 
                        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 
                        Institute; and
                            ``(iii) conduct, with the institute grants 
                        management specialist described in subparagraph 
                        (C), the fiscal management of the network.
                    ``(C) Institute management specialist.--An 
                institute grants management specialist (as defined and 
                appointed by the Director) shall assist the institute 
                project scientist in conducting the fiscal management 
                of the network 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.--
            ``(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 program under which the Director makes 
        a grant to (or enters into a contract with) a national 
        nonprofit entity with expertise in pulmonary hypertension to 
        establish and administer a national Pulmonary Hypertension 
        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 professionals (including 
        cardiologists, pulmonologists, rheumatologists, and primary 
        care physicians) by experienced pulmonary hypertension 
        specialists in clinical settings. The purpose of the program is 
        to increase 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, 
        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 identify a 
                site contact; and
                    ``(B) the Director shall specify a percentage of 
                the grant funds required to be allocated for purposes 
                of providing each such site contact with a stipend.
            ``(5) Participant recruitment and program guidelines.--The 
        nonprofit entity awarded the grant (or contract) under 
        paragraph (1) shall establish mechanisms for identifying and 
        enrolling interested 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.''.

SEC. 4. INCREASING PUBLIC AWARENESS OF PULMONARY HYPERTENSION.

    (a) Pulmonary Hypertension Education Program.--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 hypertension and its 
        symptoms;
            (2) the incidence and prevalence of pulmonary hypertension;
            (3) diseases and conditions that can lead to pulmonary 
        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 hypertension.
    (b) Dissemination of Information.--The Secretary of Health and 
Human Services shall disseminate information under subsection (a) 
through arrangements with a national non-profit entity with expertise 
in pulmonary hypertension.
    (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. 5. DISSEMINATION OF INFORMATION TO HEALTH PROFESSIONALS ON 
              PULMONARY HYPERTENSION.

    (a) Dissemination of Information.--The Secretary of Health and 
Human Services, acting through the Administrator of the Health 
Resources and Services Administration and the Director of the Centers 
for Disease Control and Prevention, shall develop and disseminate to 
health care providers information on pulmonary hypertension 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 Secretary of Health and 
Human Services shall disseminate information under subsection (a) 
through arrangements with a national non-profit entity with expertise 
in pulmonary hypertension.
    (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 standards 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 
pulmonary 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 account 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).
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