[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 908 Introduced in Senate (IS)]

113th CONGRESS
  1st Session
                                 S. 908

  To amend the Public Health Service Act to improve the diagnosis and 
   treatment of hereditary hemorrhagic telangiectasia, and for other 
                               purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 8, 2013

 Mr. Johnson of South Dakota introduced the following bill; which was 
 read twice and referred to the Committee on Health, Education, Labor, 
                              and Pensions

_______________________________________________________________________

                                 A BILL


 
  To amend the Public Health Service Act to improve the diagnosis and 
   treatment of hereditary hemorrhagic telangiectasia, 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 ``Hereditary Hemorrhagic 
Telangiectasia Diagnosis and Treatment Act of 2013''.

SEC. 2. FINDINGS.

    The Congress finds as follows:
            (1) Hereditary hemorrhagic telangiectasia (referred to in 
        this section as ``HHT'') is a largely undiagnosed or 
        misdiagnosed vascular genetic bleeding disorder resulting in 
        artery-vein malformations (referred to in this section as 
        ``AVMs''), which lead to preventable, catastrophic and 
        disabling consequences. HHT can cause sudden death at any age, 
        unless detected and treated. Early detection, screening, and 
        use of readily available treatment can prevent premature deaths 
        and long-term health complications resulting from HHT. A person 
        with HHT has the tendency to form blood vessels that lack the 
        capillaries between an artery and vein. HHT often results in 
        spontaneous hemorrhage or stroke from brain or lung AVMs. In 
        addition to hemorrhagic stroke, embolic stroke and brain 
        abscess occur in approximately 30 percent of individuals with 
        HHT AVMs in the lung (due to lack of capillaries between the 
        arterial and venous systems that normally filter out clots and 
        bacteria).
            (2) One in 5,000 American children and adults suffer from 
        HHT.
            (3) Studies have found an increase in morbidity and 
        mortality rates for individuals who suffer from HHT.
            (4) Due to the widespread lack of knowledge, accurate 
        diagnosis, and appropriate intervention, 90 percent of HHT-
        affected families are at risk for preventable life-threatening 
        and disabling medical incidents such as stroke.
            (5) Early detection, screening, and treatment can prevent 
        premature deaths, spontaneous hemorrhage, hemorrhagic stroke, 
        embolic stroke, brain abscess, and other long-term health care 
        complications resulting from HHT.
            (6) HHT is an important health condition with serious 
        health consequences which are amenable to early identification 
        and diagnosis with suitable tests, and acceptable and available 
        treatments in established treatment centers.
            (7) Timely identification and management of HHT cases is an 
        important public health objective because it will save lives, 
        prevent disability, and reduce direct and indirect health care 
        costs expenditures. A recent study has found use of a genetic 
        testing model for HHT diagnosis saves $9,900,000 if screening 
        is limited to individuals within the family groups that have 
        the gene defect, leading to early intervention in individuals 
        found to have treatable AVMs.
            (8) Without a new program for early detection, screening, 
        and treatment, 14,000 children and adults who suffer from HHT 
        in the population today will suffer premature death and 
        disability.

SEC. 3. PURPOSE.

    The purpose of this Act is to create a federally led and financed 
initiative for early diagnosis and appropriate treatment of hereditary 
hemorrhagic telangiectasia that will result in the reduction of the 
suffering of families, prevent premature death and disability, and 
lower health care costs through proven treatment interventions.

SEC. 4. NATIONAL INSTITUTES OF HEALTH.

    Part B of title IV of the Public Health Service Act (42 U.S.C. 284 
et seq.) is amended by adding at the end the following:

``SEC. 409K. HEREDITARY HEMORRHAGIC TELANGIECTASIA.

    ``(a) HHT Initiative.--
            ``(1) Establishment.--The Secretary shall establish and 
        implement an HHT initiative to assist in coordinating 
        activities to improve early detection, screening, and treatment 
        of people who suffer from HHT. Such initiative shall focus on--
                    ``(A) advancing research on the causes, diagnosis, 
                and treatment of HHT, including through the conduct or 
                support of such research; and
                    ``(B) increasing physician and public awareness of 
                HHT.
            ``(2) Consultation.--In carrying out this subsection, the 
        Secretary shall consult with the Director of the National 
        Institutes of Health and the Director of the Centers for 
        Disease Control and Prevention.
    ``(b) HHT Coordinating Committee.--
            ``(1) Establishment.--Not later than 60 days after the date 
        of the enactment of this section, the Secretary, in 
        consultation with the Director of the National Institutes of 
        Health, shall establish a committee to be known as the HHT 
        Coordinating Committee.
            ``(2) Membership.--
                    ``(A) In general.--The members of the Committee 
                shall be appointed by the Secretary, in consultation 
                with the Director of the National Institutes of Health, 
                and shall consist of 12 individuals who are experts in 
                HHT or arteriovenous malformation (AVM) as follows:
                            ``(i) Four representatives of HHT Treatment 
                        Centers of Excellence designated under section 
                        317U(c)(1).
                            ``(ii) Four experts in vascular, molecular, 
                        or basic science.
                            ``(iii) Four representatives of the 
                        National Institutes of Health.
                    ``(B) Chair.--The Secretary shall designate the 
                Chair of the Committee from among its members.
                    ``(C) Interim members.--In place of the 4 members 
                otherwise required to be appointed under subparagraph 
                (A)(i), the Secretary may appoint 4 experts in 
                vascular, molecular, or basic science to serve as 
                members of the Committee during the period preceding 
                designation and establishment of HHT Treatment Centers 
                of Excellence under section 317U.
                    ``(D) Publication of names.--Not later than 30 days 
                after the establishment of the Committee, the Secretary 
                shall publish the names of the Chair and members of the 
                Committee on the Website of the Department of Health 
                and Human Services.
                    ``(E) Terms.--The members of the Committee shall 
                each be appointed for a 3-year term and, at the end of 
                each such term, may be reappointed.
                    ``(F) Vacancies.--A vacancy on the Committee shall 
                be filled by the Secretary in the same manner in which 
                the original appointment was made.
            ``(3) Responsibilities.--The Committee shall develop and 
        coordinate implementation of a plan to advance research and 
        understanding of HHT by--
                    ``(A) conducting or supporting basic, 
                translational, and clinical research on HHT across the 
                relevant national research institutes, national 
                centers, and offices of the National Institutes of 
                Health, including the National Heart, Lung, and Blood 
                Institute; the National Institute of Neurological 
                Disorders and Stroke; the National Institutes of 
                Diabetes and Digestive and Kidney Diseases; the Eunice 
                Kennedy Shriver National Institute of Child Health and 
                Human Development; the National Cancer Institute; and 
                the Office of Rare Diseases; and
                    ``(B) conducting evaluations and making 
                recommendations to the Secretary, the Director of the 
                National Institutes of Health, and the Director of the 
                National Cancer Institute regarding the prioritization 
                and award of National Institutes of Health research 
                grants relating to HHT, including with respect to 
                grants for--
                            ``(i) expand understanding of HHT through 
                        basic, translational, and clinical research on 
                        the cause, diagnosis, prevention, control, and 
                        treatment of HHT;
                            ``(ii) training programs on HHT for 
                        scientists and health professionals; and
                            ``(iii) HHT genetic testing research to 
                        improve the accuracy of genetic testing.
    ``(c) Definitions.--In this section:
            ``(1) The term `Committee' means the HHT Coordinating 
        Committee established under subsection (b).
            ``(2) The term `HHT' means hereditary hemorrhagic 
        telangiectasia.''.

SEC. 5. CENTERS FOR DISEASE CONTROL AND PREVENTION.

    Part B of title III of the Public Health Service Act is amended by 
inserting after section 317T (42 U.S.C. 247b-22) the following:

``SEC. 317U. HEREDITARY HEMORRHAGIC TELANGIECTASIA.

    ``(a) In General.--With respect to hereditary hemorrhagic 
telangiectasia (in this section referred to as `HHT'), the Director of 
the Centers for Disease Control and Prevention (in this section 
referred to as the `Director') shall carry out the following 
activities:
            ``(1) The conduct of population screening described in 
        subsection (c).
            ``(2) The identification and conduct of investigations to 
        further develop and support guidelines for diagnosis of, and 
        intervention for, HHT, including cost-benefit studies.
            ``(3) The development of a standardized survey and 
        screening tool on family history.
            ``(4) The establishment, in collaboration with a voluntary 
        health organization representing HHT families, of an HHT 
        resource center within the Centers for Disease Control and 
        Prevention to provide comprehensive education on, and 
        disseminate information about, HHT to health professionals, 
        patients, industry, and the public.
            ``(5) The conduct or support of public awareness programs 
        in collaboration with medical, genetic, and professional 
        organizations to improve the education of health professionals 
        about HHT.
    ``(b) Collaborative Approaches.--The Director shall carry out this 
section through collaborative approaches within the National Center on 
Birth Defects and Developmental Disabilities and the Division for Heart 
Disease and Stroke Prevention of the Centers for Disease Control and 
Prevention with respect to clotting and bleeding disorders.
    ``(c) Population Screening.--In carrying out population screening 
under subsection (a)(1), the Director shall--
            ``(1) designate and provide funding for a sufficient number 
        of HHT Treatment Centers of Excellence to improve patient 
        access to information, treatment, and care by HHT experts;
            ``(2) conduct surveillance through a population study, 
        supplemented by sentinel health care provider or center 
        surveillance, and by administrative database analyses, as 
        useful, to accurately identify--
                    ``(A) the prevalence of HHT; and
                    ``(B) the prevalence of hemorrhagic and embolic 
                stroke and brain abscess, resulting from HHT;
            ``(3) include HHT screening questions in the Behavioral 
        Risk Factor Surveillance System survey conducted by the Centers 
        for Disease Control and Prevention in order to screen a broader 
        population and more accurately determine the prevalence of HHT;
            ``(4) provide data collected under paragraph (2)(B) to the 
        Paul Coverdell National Acute Stroke Registry, to facilitate--
                    ``(A) analyses of the natural history of 
                hemorrhagic and embolic stroke in HHT; and
                    ``(B) the development of screening and artery-vein 
                malformation treatment guidelines specific to 
                prevention of complications from HHT;
            ``(5) develop and implement programs, targeted for 
        physicians and health care professional groups likely to be 
        accessed by families with HHT, to increase HHT diagnosis and 
        treatment rates through the--
                    ``(A) establishment of a partnership with HHT 
                Treatment Centers of Excellence designated under 
                paragraph (1) through the creation of a database of 
                patients assessed at such HHT Treatment Centers of 
                Excellence (including with respect to phenotype 
                information, genotype information, transfusion 
                dependence, and radiological findings);
                    ``(B) integration of such database with--
                            ``(i) the universal data collection system 
                        used by the Centers for monitoring hemophilia 
                        with the blood disorders; and
                            ``(ii) the Paul Coverdell National Acute 
                        Stroke Registry; and
                    ``(C) inclusion of other medical providers who 
                treat HHT patients; and
            ``(6) use existing administrative databases on non-HHT 
        Treatment Center of Excellence patients--
                    ``(A) to learn about the natural history of HHT and 
                the efficacy of various treatment modalities; and
                    ``(B) to better inform and develop screening and 
                treatment guidelines associated with improvement in 
                health care outcomes, and research priorities relevant 
                to HHT.
    ``(d) Eligibility for Designation as HHT Treatment Center of 
Excellence.--In carrying out subsection (c)(1), the Director may 
designate as an HHT Treatment Center of Excellence an academic health 
center demonstrating each of the following:
            ``(1) The academic health center possesses a team of 
        medical experts capable of providing comprehensive evaluation, 
        treatment, and education to individuals with known or suspected 
        HHT and their health care providers.
            ``(2) The academic health center has sufficient personnel 
        with knowledge about HHT, or formal collaboration with one or 
        more partnering organizations for personnel or resources, to be 
        able to--
                    ``(A) respond in a coordinated, multidisciplinary 
                way to patient inquiries; and
                    ``(B) coordinate evaluation, treatment, and 
                education of patients and their families in a timely 
                manner.
            ``(3) The academic health center has the following 
        personnel, facilities, and patient volume:
                    ``(A) A medical director with--
                            ``(i) specialized knowledge of the main 
                        organ manifestations of HHT; and
                            ``(ii) the ability to coordinate the 
                        multidisciplinary diagnosis and treatment of 
                        patients referred to the center.
                    ``(B) Administrative staff with--
                            ``(i) sufficient knowledge to respond to 
                        patient inquiries and coordinate patient care 
                        in a timely fashion; and
                            ``(ii) adequate financial support to allow 
                        the staff to commit at least 25 to 50 percent 
                        of their time on the job to HHT.
                    ``(C) An otolaryngologist with experience and 
                expertise in the treatment of recurrent epistaxis in 
                HHT patients.
                    ``(D) An interventional radiologist with experience 
                and expertise in the treatment of pulmonary 
                arteriovenous malformations (AVM).
                    ``(E) A genetic counselor or geneticist with the 
                expertise to provide HHT-specific genetic counseling to 
                patients and families.
                    ``(F) On-site facilities to screen for all major 
                organ manifestations of HHT.
                    ``(G) A patient volume of at least 25 new HHT 
                patients per year.
                    ``(H) Established mechanisms to coordinate 
                surveillance and outreach with HHT patient advocacy 
                organizations.''.

SEC. 6. ADDITIONAL HEALTH AND HUMAN SERVICES ACTIVITIES.

    With respect to hereditary hemorrhagic telangiectasia (referred to 
in this section as ``HHT''), the Secretary of Health and Human 
Services, acting through the Administrator of the Centers for Medicare 
& Medicaid Services, shall award grants on a competitive basis--
            (1) for an analysis by grantees of the Medicare Provider 
        Analysis and Review (MEDPAR) file to develop preliminary 
        estimates from the Medicare program under title XVIII of the 
        Social Security Act for--
                    (A) preventable costs of annual health care 
                expenditures associated with untreated HHT furnished to 
                individuals with HHT, including items, services, and 
                treatments; and
                    (B) socioeconomic costs associated with preventable 
                medical events among individuals with HHT who are 
                entitled to benefits under part A of title XVIII of the 
                Social Security Act or enrolled under part B of such 
                title, such as disability expenditures; and
            (2) to make recommendations regarding an enhanced data 
        collection protocol to permit a more precise determination of 
        the total costs described in paragraph (1).

SEC. 7. AUTHORIZATION OF APPROPRIATIONS.

    (a) In General.--To carry out section 409K of the Public Health 
Service Act as added by section 4 of this Act, section 317U of the 
Public Health Service Act as added by section 5 of this Act, and 
section 6 of this Act, there is authorized to be appropriated 
$5,000,000 for each of fiscal years 2014 through 2018.
    (b) Resource Center.--Of the amount authorized to be appropriated 
under subsection (a) for each of fiscal years 2014 through 2018, 
$1,000,000 shall be for carrying out section 317U(a)(4) of the Public 
Health Service Act, as added by section 5 of this Act.
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