I 

114TH CONGRESS 

1ST SESSION H. R. 1849 

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 

APRIL 16, 2015 

Mr. ROYCE (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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Hereditary Hemor5 rhagic Telangiectasia Diagnosis and Treatment Act of 

6 2015’’. 

7 SEC. 2. FINDINGS. 

8 The Congress finds as follows: 


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1 (1) Hereditary hemorrhagic telangiectasia 

2 (HHT) is a largely undiagnosed or misdiagnosed 

3 vascular genetic bleeding disorder resulting in ar4 tery-vein malformations (AVMs) which lead to pre5 ventable catastrophic and disabling consequences. 

6 HHT can cause sudden death at any age, unless de7 tected and treated. Early detection, screening, and 

8 use of readily available treatment can prevent pre9 mature deaths and long-term health complications 

10 resulting from HHT. A person with HHT has the 

11 tendency to form blood vessels that lack the cap12 illaries between an artery and vein. HHT often re13 sults in spontaneous hemorrhage or stroke from 

14 brain or lung AVMs. In addition to hemorrhagic 

15 stroke, embolic stroke and brain abscess occur in ap16 proximately 30 percent of persons with HHT artery17 vein malformations in the lung (due to lack of cap18 illaries between the arterial and venous systems 

19 which normally filter out clots and bacteria). 

20 (2) One in 5,000 American children and adults 

21 suffer from HHT. 

22 (3) Studies have found an increase in morbidity 

23 and mortality rates for individuals who suffer from 

24 HHT. 


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1 (4) Due to the widespread lack of knowledge, 

2 accurate diagnosis, and appropriate intervention, 90 

3 percent of HHT-affected families are at risk for pre4 ventable, life-threatening, and disabling medical inci5 dents such as stroke. 

6 (5) Early detection, screening, and treatment 

7 can prevent premature deaths, spontaneous hemor8 rhage, hemorrhagic stroke, embolic stroke, brain ab9 scess, and other long-term health care complications 

10 resulting from HHT. 

11 (6) HHT is an important health condition with 

12 serious health consequences which are amenable to 

13 early identification and diagnosis with suitable tests, 

14 and acceptable and available treatments in estab15 lished treatment centers. 

16 (7) Timely identification and management of 

17 HHT cases is an important public health objective 

18 because it will save lives, prevent disability, and re19 duce direct and indirect health care costs. A recent 

20 study found that use of a genetic testing model for 

21 HHT diagnosis saves $9.9 million in that screening 

22 can be limited to those persons within the family 

23 groups who actually have the gene defect, leading to 

24 early intervention in those found to have treatable 

25 AVMs. 


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1 (8) Without a new program for early detection, 

2 screening, and treatment, 14,000 children and 

3 adults who suffer from HHT in the population today 

4 will suffer premature death and disability. 

5 SEC. 3. PURPOSE. 

6 The purpose of this Act is to create a federally led 

7 and financed initiative for early diagnosis and appropriate 

8 treatment of hereditary hemorrhagic telangiectasia that 

9 will— 

10 (1) reduce the suffering of families; 

11 (2) prevent premature death and disability; and 

12 (3) lower health care costs through proven 

13 treatment interventions. 

14 SEC. 4. CENTERS FOR DISEASE CONTROL AND PREVEN15 TION. 

16 Part B of title III of the Public Health Service Act 

17 (42 U.S.C. 243 et seq.) is amended by inserting after sec18 tion 317T the following: 

19 ‘‘SEC. 317U. HEREDITARY HEMORRHAGIC TELANGIECTA20 SIA. 

21 ‘‘(a) IN GENERAL.—With respect to hereditary hem22 orrhagic telangiectasia (in this section referred to as 

23 ‘HHT’), the Director of the Centers for Disease Control 

24 and Prevention (in this section referred to as the ‘Direc25 tor’) shall carry out the following activities: 


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1 ‘‘(1) The conduct of surveillance of the preva2 lence and incidence of HHT as described in sub3 section (c). 

4 ‘‘(2) The identification and conduct of inves5 tigations to further develop and support guidelines 

6 for diagnosis of, and intervention for, HHT, includ7 ing cost-benefit studies. 

8 ‘‘(3) The development of a standardized survey 

9 and screening tool on family history. 

10 ‘‘(4) The establishment, in collaboration with a 

11 voluntary health organization representing HHT 

12 families, of an HHT resource center within the Cen13 ters for Disease Control and Prevention to provide 

14 comprehensive education on, and disseminate infor15 mation about, HHT to health professionals, pa16 tients, industry, and the public. 

17 ‘‘(5) The conduct or support of public aware18 ness programs in collaboration with medical, genetic, 

19 and professional organizations to improve the edu20 cation of health professionals about HHT. 

21 ‘‘(b) COLLABORATIVE APPROACHES.—The Director 

22 shall carry out this section through collaborative ap23 proaches within the National Center on Birth Defects and 

24 Developmental Disabilities and the Division for Heart Dis25 ease and Stroke Prevention of the Centers for Disease 


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1 Control and Prevention for clotting and bleeding dis2 orders. 

3 ‘‘(c) RELATED ACTIVITIES.—In carrying out sub4 section (a), the Director shall— 

5 ‘‘(1) designate and provide funding for a suffi6 cient number of HHT Treatment Centers of Excel7 lence— 

8 ‘‘(A) to collect data on the prevalence of, 

9 and stroke incidence associated with, HHT; and 

10 ‘‘(B) to improve patient access to informa11 tion, diagnosis, early intervention, and treat12 ment of HHT; 

13 ‘‘(2) provide data collected under paragraph (1) 

14 to the Paul Coverdell National Acute Stroke Reg15 istry to facilitate— 

16 ‘‘(A) analyses of the natural history of 

17 hemorrhagic and embolic stroke in HHT; and 

18 ‘‘(B) development of screening and artery19 vein malformation treatment guidelines specific 

20 to prevention of complications from HHT; and 

21 ‘‘(3) develop and implement programs, targeted 

22 for physicians and health care professional groups 

23 likely to be accessed by families with HHT, to in24 crease HHT diagnosis and treatment rates through 

25 the— 


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1 ‘‘(A) establishment of a partnership with 

2 HHT Treatment Centers of Excellence des3 ignated under paragraph (1) through the cre4 ation of a database of patients assessed at such 

5 HHT Treatment Centers of Excellence (includ6 ing with respect to phenotype information, gen7 otype information, transfusion dependence, and 

8 radiological findings); and 

9 ‘‘(B) inclusion of other medical providers 

10 who treat HHT patients. 

11 ‘‘(d) ELIGIBILITY FOR DESIGNATION AS AN HHT 

12 TREATMENT CENTER OF EXCELLENCE.—In carrying out 

13 subsection (c)(1), the Director may designate, as an HHT 

14 Treatment Center of Excellence, only academic health cen15 ters demonstrated to have each of the following: 

16 ‘‘(1) A team of medical experts capable of pro17 viding comprehensive evaluation, treatment, and 

18 education to individuals with known or suspected 

19 HHT and their health care providers. 

20 ‘‘(2) Administrative staff with sufficient knowl21 edge to respond to patient inquiries and coordinate 

22 patient care in a timely fashion.’’. 


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1 SEC. 5. ADDITIONAL HEALTH AND HUMAN SERVICES AC2 TIVITIES. 

3 With respect to hereditary hemorrhagic telangiectasia 

4 (in this section referred to as ‘‘HHT’’), the Secretary of 

5 Health and Human Services, acting through the Adminis6 trator of the Centers for Medicare & Medicaid Services, 

7 shall award grants on a competitive basis— 

8 (1) for an analysis by grantees of the Medicare 

9 Provider Analysis and Review (MEDPAR) file to de10 velop preliminary estimates from the Medicare pro11 gram under title XVIII of the Social Security Act 

12 for preventable costs of annual health care expendi13 tures including items, services, and treatments asso14 ciated with untreated HHT furnished to individuals 

15 with HHT, as well as socioeconomic costs such as 

16 disability expenditures associated with preventable 

17 medical events in this population, who are entitled to 

18 benefits under part A of title XVIII of the Social Se19 curity Act or enrolled under part B of such title; and 

20 (2) to make recommendations regarding an en21 hanced data collection protocol to permit a more 

22 precise determination of the total costs described in 

23 paragraph (1). 


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1 SEC. 6. NATIONAL INSTITUTES OF HEALTH. 

2 Part B of title IV of the Public Health Service Act 

3 (42 U.S.C. 284 et seq.) is amended by adding at the end 

4 the following: 

5 ‘‘SEC. 409K. HEREDITARY HEMORRHAGIC TELANGIECTASIA. 

6 ‘‘(a) HHT INITIATIVE.— 

7 ‘‘(1) ESTABLISHMENT.—The Secretary shall es8 tablish and implement an HHT initiative to assist in 

9 coordinating activities to improve early detection, 

10 screening, and treatment of people who suffer from 

11 HHT. Such initiative shall focus on— 

12 ‘‘(A) advancing research on the causes, di13 agnosis, and treatment of HHT, including 

14 through the conduct or support of such re15 search; and 

16 ‘‘(B) increasing physician and public 

17 awareness of HHT. 

18 ‘‘(2) CONSULTATION.—In carrying out this sub19 section, the Secretary shall consult with the Director 

20 of the National Institutes of Health and the Director 

21 of the Centers for Disease Control and Prevention. 

22 ‘‘(b) HHT COORDINATING COMMITTEE.— 

23 ‘‘(1) ESTABLISHMENT.—Not later than 60 days 

24 after the date of enactment of this section, the Sec25 retary, in consultation with the Director of the Na26 tional Institutes of Health, shall establish a comVerDate Sep 11 2014 00:28 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H1849.IH H1849

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1 mittee to be known as the HHT Coordinating Com2 mittee. 

3 ‘‘(2) MEMBERSHIP.— 

4 ‘‘(A) IN GENERAL.—The members of the 

5 Committee shall be appointed by the Secretary, 

6 in consultation with the Director of the Na7 tional Institutes of Health, and shall consist of 

8 12 individuals who are experts in HHT or 

9 arteriovenous malformation (AVM) as follows: 

10 ‘‘(i) Four representatives of HHT 

11 Treatment Centers of Excellence des12 ignated under section 317U(c)(1). 

13 ‘‘(ii) Four experts in vascular, molec14 ular, or basic science. 

15 ‘‘(iii) Four representatives of the Na16 tional Institutes of Health. 

17 ‘‘(B) CHAIR.—The Secretary shall des18 ignate the Chair of the Committee from among 

19 its members. 

20 ‘‘(C) INTERIM MEMBERS.—In place of the 

21 4 members otherwise required to be appointed 

22 under subparagraph (A)(i), the Secretary may 

23 appoint 4 experts in vascular, molecular, or 

24 basic science to serve as members of the Com25 mittee during the period preceding designation 


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1 and establishment of HHT Treatment Centers 

2 of Excellence under section 317U. 

3 ‘‘(D) PUBLICATION OF NAMES.—Not later 

4 than 30 days after the establishment of the 

5 Committee, the Secretary shall publish the 

6 names of the Chair and members of the Com7 mittee on the public Web site of the Depart8 ment of Health and Human Services. 

9 ‘‘(E) TERMS.—The members of the Com10 mittee shall each be appointed for a 3-year term 

11 and, at the end of each such term, may be re12 appointed. 

13 ‘‘(F) VACANCIES.—A vacancy on the Com14 mittee shall be filled by the Secretary in the 

15 same manner in which the original appointment 

16 was made. 

17 ‘‘(3) RESPONSIBILITIES.—The Committee shall 

18 develop and coordinate implementation of a plan to 

19 advance research and understanding of HHT by— 

20 ‘‘(A) conducting or supporting basic, 

21 translational, and clinical research on HHT 

22 across the relevant national research institutes, 

23 national centers, and offices of the National In24 stitutes of Health, including the National 

25 Heart, Lung, and Blood Institute; the National 


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1 Institute of Neurological Disorders and Stroke; 

2 the National Institutes of Diabetes and Diges3 tive and Kidney Diseases; the Eunice Kennedy 

4 Shriver National Institute of Child Health and 

5 Human Development; the National Cancer In6 stitute; the National Human Genome Research 

7 Institute; the National Center for Advancing 

8 Translational Sciences (including the Office of 

9 Rare Diseases Research); and the National In10 stitute of Biomedical Imaging and Bio11 engineering; and 

12 ‘‘(B) conducting evaluations and making 

13 recommendations to the Secretary, the Director 

14 of the National Institutes of Health, and the 

15 Director of the National Cancer Institute re16 garding the prioritization and award of Na17 tional Institutes of Health research grants re18 lating to HHT, including with respect to grants 

19 for— 

20 ‘‘(i) expanding understanding of HHT 

21 through basic, translational, and clinical 

22 research on the cause, diagnosis, preven23 tion, control, and treatment of HHT; 

24 ‘‘(ii) training programs on HHT for 

25 scientists and health professionals; and 


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1 ‘‘(iii) HHT genetic testing research to 

2 improve the accuracy of genetic testing. 

3 ‘‘(c) DEFINITIONS.—In this section: 

4 ‘‘(1) The term ‘Committee’ means the HHT 

5 Coordinating Committee established under sub6 section (b). 

7 ‘‘(2) The term ‘HHT’ means hereditary hemor8 rhagic telangiectasia.’’. 

9 SEC. 7. AUTHORIZATION OF APPROPRIATIONS. 

10 (a) IN GENERAL.—To carry out section 317U of the 

11 Public Health Service Act as added by section 4 of this 

12 Act, section 5 of this Act, and section 409K of the Public 

13 Health Service Act as added by section 6 of this Act, there 

14 is authorized to be appropriated $5,000,000 for each of 

15 fiscal years 2016 through 2020. 

16 (b) RESOURCE CENTER.—Of the amount authorized 

17 to be appropriated under subsection (a) for each of fiscal 

18 years 2016 through 2020, $1,000,000 shall be for car19 rying out section 317U(a)(4) of the Public Health Service 

20 Act (providing for an HHT resource center), as added by 

21 section 4 of this Act. 

22 (c) OFFSET.—There is authorized to be appropriated 

23 to the Department of Health and Human Services for sal24 aries and expenses of the Department for each of fiscal 

25 years 2016 through 2020 the amount that is $5,000,000 


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1 less than the amount appropriated for such salaries and 

2 expenses for fiscal year 2015. 

Æ 


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