```

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 2465 Reported in Senate (RS)]

<DOC>

                                                       Calendar No. 553
115th CONGRESS
  2d Session
                                S. 2465

  To amend the Public Health Service Act to reauthorize a sickle cell 
 disease prevention and treatment demonstration program and to provide 
    for sickle cell disease research, surveillance, prevention, and 
                               treatment.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                           February 28, 2018

    Mr. Scott (for himself, Mr. Booker, Mr. Jones, Mr. Cassidy, Ms. 
  Stabenow, Ms. Warren, and Mr. Brown) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

                            August 15, 2018

              Reported by Mr. Alexander, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 A BILL

 
  To amend the Public Health Service Act to reauthorize a sickle cell 
 disease prevention and treatment demonstration program and to provide 
    for sickle cell disease research, surveillance, prevention, and 
                               treatment.

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

<DELETED>SECTION 1. SHORT TITLE; TABLE OF CONTENTS.</DELETED>

<DELETED>    (a) Short Title.--This Act may be cited as the ``Sickle 
Cell Disease Research, Surveillance, Prevention, and Treatment Act of 
2018''.</DELETED>
<DELETED>    (b) Table of Contents.--The table of contents of this Act 
is as follows:</DELETED>

<DELETED>Sec. 1. Short title; table of contents.
<DELETED>Sec. 2. Sense of the Senate.
<DELETED>Sec. 3. Sickle cell disease surveillance.
<DELETED>Sec. 4. Sickle cell disease prevention and treatment.
<DELETED>Sec. 5. Collaboration with community-based entities.

<DELETED>SEC. 2. SENSE OF THE SENATE.</DELETED>

<DELETED>    It is the Sense of the Senate that further research should 
be undertaken to expand the understanding of the cause of, and to find 
a cure for, sickle cell disease.</DELETED>

<DELETED>SEC. 3. SICKLE CELL DISEASE SURVEILLANCE.</DELETED>

<DELETED>    Part P of title III of the Public Health Service Act is 
amended by inserting after section 399V-6 (42 U.S.C. 280g-17) the 
following:</DELETED>

<DELETED>``SEC. 399V-7. NATIONAL SICKLE CELL DISEASE SURVEILLANCE, 
              PREVENTION, AND TREATMENT PROGRAM.</DELETED>

<DELETED>    ``(a) Surveillance.--</DELETED>
        <DELETED>    ``(1) Grants.--The Secretary may, for each fiscal 
        year for which appropriations are available to carry out this 
        subsection, make grants to not more than 20 eligible entities 
        for the following purposes:</DELETED>
                <DELETED>    ``(A) To conduct surveillance and maintain 
                data on the prevalence and distribution of sickle cell 
                disease and its associated health outcomes, 
                complications, and treatments.</DELETED>
                <DELETED>    ``(B) To conduct public health initiatives 
                with respect to sickle cell disease, including one or 
                more of the following:</DELETED>
                        <DELETED>    ``(i) Increasing efforts to 
                        improve access to high-quality sickle cell 
                        disease-related health care, including the use 
                        of treatments approved under section 505 of the 
                        Federal Food, Drug, and Cosmetic Act or 
                        licensed under section 351 of this 
                        Act.</DELETED>
                        <DELETED>    ``(ii) Working with partners to 
                        improve health outcomes of people with sickle 
                        cell disease over the lifespan by promoting 
                        guidelines for sickle cell disease screening, 
                        prevention, and treatment, including management 
                        of sickle cell disease complications.</DELETED>
                        <DELETED>    ``(iii) Providing support to 
                        community-based organizations and State and 
                        local health departments in conducting sickle 
                        cell disease education and training activities 
                        for patients, communities, and health care 
                        providers.</DELETED>
                        <DELETED>    ``(iv) Supporting and training 
                        State health departments and regional 
                        laboratories in comprehensive testing to 
                        identify specific forms of sickle cell disease 
                        in people of all ages.</DELETED>
                <DELETED>    ``(C) To identify and evaluate promising 
                strategies for prevention and treatment of sickle cell 
                disease complications, including through one or more of 
                the following:</DELETED>
                        <DELETED>    ``(i) Improving estimates of the 
                        national incidence and prevalence of sickle 
                        cell disease, including estimates about the 
                        specific types of sickle cell 
                        disease.</DELETED>
                        <DELETED>    ``(ii) Identifying health 
                        disparities related to sickle cell 
                        disease.</DELETED>
                        <DELETED>    ``(iii) Assessing the utilization 
                        of therapies and strategies to prevent 
                        complications related to sickle cell 
                        disease.</DELETED>
                        <DELETED>    ``(iv) Evaluating the impact of 
                        genetic, environmental, behavioral, and other 
                        risk factors that may affect sickle cell 
                        disease health outcomes.</DELETED>
        <DELETED>    ``(2) Population included.--The Secretary shall, 
        to the extent practicable, award grants under this subsection 
        to eligible entities across the United States so as to include 
        data on the majority of the United States population with 
        sickle cell disease.</DELETED>
        <DELETED>    ``(3) Application.--To seek a grant under this 
        subsection, an eligible entity shall submit an application to 
        the Secretary at such time, in such manner, and containing such 
        information as the Secretary may require.</DELETED>
        <DELETED>    ``(4) Eligible entity.--In this subsection, the 
        term `eligible entity' includes the 50 States, the District of 
        Columbia, the Commonwealth of Puerto Rico, the United States 
        Virgin Islands, the Commonwealth of the Northern Mariana 
        Islands, American Samoa, Guam, the Federated States of 
        Micronesia, the Republic of Marshall Islands, the Republic of 
        Palau, a State health or public health department, an 
        institution of higher education, or a nonprofit 
        entity.''.</DELETED>

<DELETED>SEC. 4. SICKLE CELL DISEASE PREVENTION AND 
              TREATMENT.</DELETED>

<DELETED>    (a) Reauthorization.--Section 712(c) of the American Jobs 
Creation Act of 2004 (Public Law 108-357; 42 U.S.C. 300b-1 note) is 
amended--</DELETED>
        <DELETED>    (1) by striking ``Sickle Cell Disease'' each place 
        it appears and inserting ``sickle cell disease'';</DELETED>
        <DELETED>    (2) in paragraph (1)(A), by striking ``grants to 
        up to 40 eligible entities for each fiscal year in which the 
        program is conducted under this section for the purpose of 
        developing and establishing systemic mechanisms to improve the 
        prevention and treatment of Sickle Cell Disease'' and inserting 
        ``grants to up to 25 eligible entities for each fiscal year in 
        which the program is conducted under this section for the 
        purpose of developing and establishing systemic mechanisms to 
        improve the prevention and treatment of sickle cell disease in 
        populations with a high density of sickle cell disease 
        patients'';</DELETED>
        <DELETED>    (3) in paragraph (1)(B)--</DELETED>
                <DELETED>    (A) by striking clause (ii) (relating to 
                priority); and</DELETED>
                <DELETED>    (B) by striking ``Grant award 
                requirements'' and all that follows through ``The 
                Administrator shall'' and inserting ``Geographic 
                diversity.--The Administrator shall'';</DELETED>
        <DELETED>    (4) in paragraph (2), by adding the following new 
        subparagraph at the end:</DELETED>
                <DELETED>    ``(E) To expand, coordinate, and implement 
                transition services for adolescents with sickle cell 
                disease making the transition to adult health care.''; 
                and</DELETED>
        <DELETED>    (5) in paragraph (6), by striking ``$10,000,000 
        for each of fiscal years 2005 through 2009'' and inserting 
        ``$4,455,000 for each of fiscal years 2018 through 
        2022''.</DELETED>
<DELETED>    (b) Technical Changes.--Subsection (c) of section 712 of 
the American Jobs Creation Act of 2004 (Public Law 108-357; 42 U.S.C. 
300b-1 note), as amended by subsection (a), is--</DELETED>
        <DELETED>    (1) transferred to the Public Health Service Act 
        (42 U.S.C. 201 et seq.);</DELETED>
        <DELETED>    (2) redesignated as subsection (b); and</DELETED>
        <DELETED>    (3) inserted at the end of section 399V-7 of such 
        Act, as added by section 2 of this Act.</DELETED>

<DELETED>SEC. 5. COLLABORATION WITH COMMUNITY-BASED ENTITIES.</DELETED>

<DELETED>    Section 399V-7 of the Public Health Service Act, as 
amended by section 3, is further amended by adding at the end the 
following:</DELETED>
<DELETED>    ``(c) Collaboration With Community-Based Entities.--To be 
eligible to receive a grant or other assistance under subsection (a) or 
(b), an eligible entity must have in effect a collaborative agreement 
with a community-based organization with five or more years of 
experience in providing services to sickle cell disease 
patients.''.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Sickle Cell Disease and Other 
Heritable Blood Disorders Research, Surveillance, Prevention, and 
Treatment Act of 2018''.

SEC. 2. DATA COLLECTION ON CERTAIN BLOOD DISORDERS.

    Part A of title XI of the Public Health Service Act is amended by 
inserting after section 1105 (42 U.S.C. 300b-4) the following:

``SEC. 1106. SICKLE CELL DISEASE AND OTHER HERITABLE BLOOD DISORDERS 
              RESEARCH, SURVEILLANCE, PREVENTION, AND TREATMENT.

    ``(a) Grants.--
            ``(1) In general.--The Secretary may award grants related 
        to heritable blood disorders, including sickle cell disease, 
        for one or more of the following purposes:
                    ``(A) To collect and maintain data on such diseases 
                and conditions, including subtypes as applicable, and 
                their associated health outcomes and complications, 
                including for the purpose of--
                            ``(i) improving national incidence and 
                        prevalence data;
                            ``(ii) identifying health disparities, 
                        including the geographic distribution, related 
                        to such diseases and conditions;
                            ``(iii) assessing the utilization of 
                        therapies and strategies to prevent 
                        complications; and
                            ``(iv) evaluating the effects of genetic, 
                        environmental, behavioral, and other risk 
                        factors that may affect such individuals.
                    ``(B) To conduct public health activities with 
                respect to such conditions, which may include--
                            ``(i) developing strategies to improve 
                        health outcomes and access to quality health 
                        care for the screening for, and treatment and 
                        management of, such diseases and conditions, 
                        including through public-private partnerships;
                            ``(ii) providing support to community-based 
                        organizations and State and local health 
                        departments in conducting education and 
                        training activities for patients, communities, 
                        and health care providers concerning such 
                        diseases and conditions;
                            ``(iii) supporting State health departments 
                        and regional laboratories, including through 
                        training, in testing to identify such diseases 
                        and conditions, including specific forms of 
                        sickle cell disease, in individuals of all 
                        ages; and
                            ``(iv) the identification and evaluation of 
                        best practices for treatment of such diseases 
                        and conditions, and prevention and management 
                        of their related complications.
            ``(2) Population included.--The Secretary shall, to the 
        extent practicable, award grants under this subsection to 
        eligible entities across the United States to improve data on 
        the incidence and prevalence of heritable blood disorders, 
        including sickle cell disease, and the geographic distribution 
        of such diseases and conditions.
            ``(3) Application.--To seek a grant under this subsection, 
        an eligible entity shall submit an application to the Secretary 
        at such time, in such manner, and containing such information 
        as the Secretary may require.
            ``(4) Priority.--In awarding grants under this subsection, 
        the Secretary may give priority, as appropriate, to eligible 
        entities that have a relationship with a community-based 
        organization that has experience in, or is capable of, 
        providing services to individuals with heritable blood 
        disorders, including sickle cell disease.
            ``(5) Eligible entity.--In this subsection, the term 
        `eligible entity' includes the 50 States, the District of 
        Columbia, the Commonwealth of Puerto Rico, the United States 
        Virgin Islands, the Commonwealth of the Northern Mariana 
        Islands, American Samoa, Guam, the Federated States of 
        Micronesia, the Republic of Marshall Islands, the Republic of 
        Palau, Indian tribes, a State or local health department, an 
        institution of higher education, or a nonprofit entity with 
        appropriate experience to conduct the activities under this 
        subsection.''.

SEC. 3. SICKLE CELL DISEASE PREVENTION AND TREATMENT.

    (a) Reauthorization.--Section 712(c) of the American Jobs Creation 
Act of 2004 (Public Law 108-357; 42 U.S.C. 300b-1 note) is amended--
            (1) by striking ``Sickle Cell Disease'' each place it 
        appears and inserting ``sickle cell disease'';
            (2) in paragraph (1)(A), by striking ``shall conduct a 
        demonstration program by making grants to up to 40 eligible 
        entities for each fiscal year in which the program is conducted 
        under this section for the purpose of developing and 
        establishing systemic mechanisms to improve the prevention and 
        treatment of Sickle Cell Disease'' and inserting ``shall 
        continue efforts, including by awarding grants, to develop or 
        establish mechanisms to improve the treatment of sickle cell 
        disease, and to improve the prevention and treatment of 
        complications of sickle cell disease, in populations with a 
        high proportion of individuals with sickle cell disease'';
            (3) in paragraph (1)(B)--
                    (A) by striking clause (ii) (relating to priority); 
                and
                    (B) by striking ``Grant award requirements'' and 
                all that follows through ``The Administrator shall'' 
                and inserting ``Geographic diversity.--The 
                Administrator shall'';
            (4) in paragraph (2), by adding the following new 
        subparagraph at the end:
                    ``(E) To provide or coordinate services for 
                adolescents with sickle cell disease making the 
                transition to adult health care.''; and
            (5) in paragraph (6), by striking ``$10,000,000 for each of 
        fiscal years 2005 through 2009'' and inserting ``$4,455,000 for 
        each of fiscal years 2019 through 2023''.
    (b) Technical Changes.--Subsection (c) of section 712 of the 
American Jobs Creation Act of 2004 (Public Law 108-357; 42 U.S.C. 300b-
1 note), as amended by subsection (a), is--
            (1) transferred to the Public Health Service Act (42 U.S.C. 
        201 et seq.);
            (2) redesignated as subsection (b); and
            (3) inserted at the end of section 1106 of such Act, as 
        added by section 2 of this Act.

SEC. 4. SENSE OF THE SENATE.

    It is the Sense of the Senate that further research should be 
undertaken to expand the understanding of the causes of, and to find 
cures for, heritable blood disorders, including sickle cell disease.
                                                       Calendar No. 553

115th CONGRESS

  2d Session

                                S. 2465

_______________________________________________________________________

                                 A BILL

  To amend the Public Health Service Act to reauthorize a sickle cell 
 disease prevention and treatment demonstration program and to provide 
    for sickle cell disease research, surveillance, prevention, and 
                               treatment.

_______________________________________________________________________

                            August 15, 2018

                       Reported with an amendment
```