Hereditary Hemorrhagic Telangiectasia Diagnosis and Treatment Act of 2014 - Amends the Public Health Service Act to require the Secretary of Health and Human Services (HHS) to establish and implement a hereditary hemorrhagic telangiectasia (HHT, a vascular genetic bleeding disorder that causes abnormalities of the blood vessels) initiative to assist in coordinating activities to improve early detection, screening, and treatment of people who suffer from HHT, focusing on advancing research on the causes, diagnosis, and treatment of HHT and increasing physician and public awareness of HHT.
Directs the Secretary to establish the HHT Coordinating Committee to develop and coordinate implementation of a plan to advance research and understanding of HHT, including by: (1) conducting or supporting research across relevant National Institutes of Health (NIH) institutes, and (2) conducting evaluations and making recommendations regarding the prioritization and award of NIH research grants relating to HHT.
Requires the Director of the Centers for Disease Control and Prevention (CDC) to carry out activities with respect to HHT, including conducting population screening and establishing an HHT resource center to provide comprehensive education on and disseminate information about HHT to health professionals, patients, industry, and the public.
Requires the Administrator of the Centers for Medicare & Medicaid Services (CMS) to award grants for research, including an analysis of health care expenditures associated with untreated HHT and costs associated with preventable medical events among Medicare beneficiaries with HHT.
[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4592 Introduced in House (IH)]
113th CONGRESS
2d Session
H. R. 4592
To amend the Public Health Service Act to improve the diagnosis and
treatment of hereditary hemorrhagic telangiectasia, and for other
purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 7, 2014
Mr. Gerlach (for himself and Mr. Himes) 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 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 2014''.
SEC. 2. FINDINGS.
The Congress finds as follows:
(1) Hereditary hemorrhagic telangiectasia (HHT) is a
largely undiagnosed or misdiagnosed vascular genetic bleeding
disorder resulting in artery-vein malformations (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 AVM. In addition to
hemorrhagic stroke, embolic stroke and brain abscess occur in
approximately 30 percent of persons with HHT artery-vein
malformations in the lung (due to lack of capillaries between
the arterial and venous systems which 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 $9.9 million in that
screening can be limited to those persons within the family
groups who actually have the gene defect, leading to early
intervention in those 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. 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 for 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 by means of 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) 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 Centers 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 an HHT Treatment Center of
Excellence.--In carrying out subsection (c)(1), the Director may
designate, as an HHT Treatment Center of Excellence, academic health
centers 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. 5. ADDITIONAL HEALTH AND HUMAN SERVICES ACTIVITIES.
With respect to hereditary hemorrhagic telangiectasia (in this
section referred to 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 preventable costs of annual health care
expenditures including items, services, and treatments
associated with untreated HHT furnished to individuals with
HHT, as well as socioeconomic costs such as disability
expenditures associated with preventable medical events in this
population, who are entitled to benefits under part A of title
XVIII of the Social Security Act or enrolled under part B of
such title; 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. 6. 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) expanding 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. 7. AUTHORIZATION OF APPROPRIATIONS.
(a) In General.--To carry out section 317U of the Public Health
Service Act as added by section 4 of this Act, section 5 of this Act,
and section 409K of the Public Health Service Act as added by section 6
of this Act, there is authorized to be appropriated $5,000,000 for each
of fiscal years 2015 through 2019.
(b) Resource Center.--Of the amount authorized to be appropriated
under subsection (a) for each of fiscal years 2015 through 2019,
$1,000,000 shall be for carrying out section 317U(a)(4) of the Public
Health Service Act, as added by section 4 of this Act.
(c) Offset.--There is authorized to be appropriated to the
Department of Health and Human Services for salaries and expenses of
the Department for each of fiscal years 2015 through 2019 the amount
that is $5,000,000 less than the amount appropriated for such salaries
and expenses for fiscal year 2014.
<all>
Introduced in House
Introduced in House
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.
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.
Referred to the Subcommittee on Health.
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