[House Report 115-354]
[From the U.S. Government Publishing Office]



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115th Congress    }                                 {         Report
                        HOUSE OF REPRESENTATIVES
 1st Session      }                                 {         115-354
======================================================================



 
 SICKLE CELL DISEASE RESEARCH, SURVEILLANCE, PREVENTION, AND TREATMENT 
                              ACT OF 2017

                                _______
                                

October 19, 2017.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

 Mr. Walden, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 2410]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 2410) 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, having 
considered the same, report favorably thereon without amendment 
and recommend that the bill do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................     2
Background and Need for Legislation..............................     2
Committee Action.................................................     2
Committee Votes..................................................     3
Oversight Findings and Recommendations...........................     3
New Budget Authority, Entitlement Authority, and Tax Expenditures     3
Congressional Budget Office Estimate.............................     3
Federal Mandates Statement.......................................     4
Statement of General Performance Goals and Objectives............     4
Duplication of Federal Programs..................................     4
Committee Cost Estimate..........................................     4
Earmark, Limited Tax Benefits, and Limited Tariff Benefits.......     4
Disclosure of Directed Rule Makings..............................     4
Advisory Committee Statement.....................................     5
Applicability to Legislative Branch..............................     5
Section-by-Section Analysis of the Legislation...................     5
Changes in Existing Law Made by the Bill, as Reported............     5

                          Purpose and Summary

    H.R. 2410 was introduced on May 11, 2017, by Rep. Danny K. 
Davis (D-IL). H.R. 2410 reauthorizes the Sickle Cell Disease 
Treatment Demonstration Program under the Public Health Service 
Act. The bill increases sickle cell disease (SCD) research and 
surveillance. It also authorizes grants for improving outreach 
and treatment in populations with a high density of SCD 
patients, emphasizing collaboration with community-based 
entities with experience in providing services to patients with 
this disease.

                  Background and Need for Legislation

    Sickle Cell Disease is a group of inherited blood cell 
disorders that results in misshapen blood cells, creating 
blockages in small blood vessels, leading to various health 
care complications ranging from mild discomfort to death. The 
exact number of those living with SCD in the United States is 
unknown, but the Centers for Disease Control and Prevention 
estimate that SCD affects approximately 100,000 Americans, 
occurring in about one out of every 365 African-American 
births.
    Treatments for this disease are limited and focus on 
relieving symptoms, reducing pain, and avoiding crises and 
complications. At this time, hematopoietic stem cell 
transplantation is the only cure. Enhancing research and 
surveillance efforts will improve current understanding of this 
life-long disease and potentially lead to a cure. Collaboration 
with community-based organizations treating SCD patients 
provides an opportunity to reduce costs while enhancing health 
outcomes.

                            Committee Action

    During the 114th Congress, on September 8, 2016, the 
Subcommittee on Health held a hearing on H.R. 1807, which was 
substantially similar to H.R. 2410. The hearing was entitled 
``Examining Legislation to Improve Public Health.'' The 
Subcommittee received testimony from:
           Sonja L. Banks, President and COO, Sickle 
        Cell Disease Association of America, Inc.;
           General Arthur Dean, Chairman and CEO, 
        Community Anti-Drug Coalitions of America;
           Jonathan Leffert, President-Elect, American 
        Association of Clinical Endocrinologists;
           Brad Marino, Chair, Pediatric Congenital 
        Heart Association; and
           R. Sean Morrison, Director, National 
        Palliative Care Research Center.
    On May 18, 2017, the Subcommittee on Health met in open 
markup session and forwarded H.R. 2410, without amendment, to 
the full Committee by a voice vote. On June 7, 2017, the full 
Committee on Energy and Commerce met in open markup session and 
ordered H.R. 2410, without amendment, favorably reported to the 
House by a voice vote.

                            Committee Votes

    Clause 3(b) of rule XIII requires the Committee to list the 
record votes on the motion to report legislation and amendments 
thereto. There were no record votes taken in connection with 
ordering H.R. 2410 reported.

                 Oversight Findings and Recommendations

    Pursuant to clause 2(b)(1) of rule X and clause 3(c)(1) of 
rule XIII, the Committee has not held hearings on this 
legislation.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    Pursuant to clause 3(c)(2) of rule XIII, the Committee 
finds that H.R. 2410 would result in no new or increased budget 
authority, entitlement authority, or tax expenditures or 
revenues.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII, the following is 
the cost estimate provided by the Congressional Budget Office 
pursuant to section 402 of the Congressional Budget Act of 
1974.

                                     U.S. Congress,
                               Congressional Budget Office,
                                Washington, DC. September 22, 2017.
Hon. Greg Walden,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 2410, the Sickle 
Cell Disease Research, Surveillance, Prevention, and Treatment 
Act of 2017.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Rebecca Yip.
            Sincerely,
                                                Keith Hall,
                                                          Director.
    Enclosure.

H.R. 2410--Sickle Cell Disease Research, Surveillance, Prevention, and 
        Treatment Act of 2017

    H.R. 2410 would authorize the Secretary of Health and Human 
Services, through the Centers for Disease Control and 
Prevention (CDC), to conduct surveillance and collect data on 
the prevalence of sickle cell disease (SCD). In addition, the 
bill would authorize the Secretary to develop public health 
initiatives that support community-based organizations in 
education activities and to support regional and state health 
departments in testing to identify SCD. H.R. 2410 would 
authorize the appropriation of about $4.5 million a year for 
fiscal years 2018 through 2022 to carry out those activities.
    The bill would require CDC to build upon past activities 
related to SCD by conducting surveillance and developing public 
health initiatives through grants to States. Previous funding 
from the American Jobs Creation Act of 2004 of $10 million a 
year for SCD expired in 2009. There has been no explicit 
funding for SCD since 2009. However, CDC has continued to 
conduct activities related to SCD and other blood disorders. 
Based on historical spending for similar activities, CBO 
estimates that implementing H.R. 2410 would cost $18 million 
over the 2018-2022 period, primarily for additional staff and 
other administrative costs; the remaining amounts would be 
spent after 2022. Enacting H.R. 2410 would not affect direct 
spending or revenues; therefore, pay-as-you-go procedures do 
not apply.
    CBO estimates that enacting the legislation would not 
increase net direct spending or on-budget deficits in any of 
the four consecutive 10-year periods beginning in 2028.
    H.R. 2410 contains no intergovernmental or private-sector 
mandates as defined in the Unfunded Mandates Reform Act and 
would impose no costs on state, local, or tribal governments.
    The CBO staff contact for this estimate is Rebecca Yip. The 
estimate was approved by Holly Harvey, Deputy Assistant 
Director for Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

         Statement of General Performance Goals and Objectives

    Pursuant to clause 3(c)(4) of rule XIII, the general 
performance goal or objective of this legislation is to improve 
SCD research, surveillance and outreach initiatives that 
enhance the treatment of SCD, emphasizing collaboration with 
community-based entities with experience in providing services 
to patients with this disease.

                    Duplication of Federal Programs

    Pursuant to clause 3(c)(5) of rule XIII, no provision of 
H.R. 2410 is known to be duplicative of another Federal 
program, including any program that was included in a report to 
Congress pursuant to section 21 of Public Law 111-139 or the 
most recent Catalog of Federal Domestic Assistance.

                        Committee Cost Estimate

    Pursuant to clause 3(d)(1) of rule XIII, the Committee 
adopts as its own the cost estimate prepared by the Director of 
the Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974.

       Earmark, Limited Tax Benefits, and Limited Tariff Benefits

    Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, [the 
Committee finds that H.R. 2410 contains no earmarks, limited 
tax benefits, or limited tariff benefits.

                  Disclosure of Directed Rule Makings

    Pursuant to section 3(i) of H. Res. 5, the Committee finds 
that H.R. 2410 contains no directed rule makings.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation


Section 1. Short title; table of contents

    Section 1 provides that the Act may be cited as the 
``Sickle Cell Disease Research, Surveillance, Prevention and 
Treatment Act of 2017.''

Section 2. Sickle cell disease research

    Section 2 authorizes the Secretary to conduct and support 
research to further understand the causes of sickle cell 
disease and to find a cure for sickle cell disease.

Section 3. Sickle cell disease surveillance

    Section 3 authorizes the Secretary to make grants to States 
to conduct surveillance on the epidemiology of sickle cell 
disease, implement public health initiatives, and identify and 
evaluate sickle cell disease prevention and treatment 
strategies.

Section 4. Sickle cell disease prevention and treatment

    Section 4 reauthorizes the Sickle Cell Disease Treatment 
Demonstration Program under the Public Health Service Act, 
providing for grants to 25 eligible entities to develop and 
establish mechanisms to improve prevention and treatment in 
populations with a high density of sickle cell disease 
patients.

Section 5. Collaboration with community-based entities

    Section 5 requires eligible grantees to have a 
collaborative agreement with a community-based organization 
with at least five years of experience in providing services to 
sickle cell disease patients.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (new matter is 
printed in italic and existing law in which no change is 
proposed is shown in roman):

                       PUBLIC HEALTH SERVICE ACT




           *       *       *       *       *       *       *
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE

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PART P--ADDITIONAL PROGRAMS

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SEC. 399V-7. NATIONAL SICKLE CELL DISEASE RESEARCH, SURVEILLANCE, 
                    PREVENTION, AND TREATMENT PROGRAM.

  (a) Research.--The Secretary may conduct or support research 
to expand the understanding of the cause of, and to find a cure 
for, sickle cell disease.
  (b) Surveillance.--
          (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 
        States--
                  (A) to conduct surveillance and maintain data 
                on the prevalence and distribution of sickle 
                cell disease and its associated health 
                outcomes, complications, and treatments;
                  (B) to conduct public health initiatives with 
                respect to sickle cell disease, including--
                          (i) increasing efforts to improve 
                        access to, and receipt of, 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;
                          (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;
                          (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; and
                          (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; and
                  (C) to identify and evaluate promising 
                strategies for prevention and treatment of 
                sickle cell disease complications, including 
                through--
                          (i) improving estimates of the 
                        national incidence and prevalence of 
                        sickle cell disease, including 
                        estimates about the specific types of 
                        sickle cell disease;
                          (ii) identifying health disparities 
                        related to sickle cell disease;
                          (iii) assessing the utilization of 
                        therapies and strategies to prevent 
                        complications related to sickle cell 
                        disease; and
                          (iv) evaluating the impact of 
                        genetic, environmental, behavioral, and 
                        other risk factors that may affect 
                        sickle cell disease health outcomes.
          (2) Population included.--The Secretary shall, to the 
        extent practicable, award grants under this subsection 
        to States across the United States so as to include 
        data on the majority of the United States population 
        with sickle cell disease.
          (3) Application.--To seek a grant under this 
        subsection, a State shall submit an application to the 
        Secretary at such time, in such manner, and containing 
        such information as the Secretary may require.
          (4) Definitions.--In this subsection:
                  (A) The term ``Secretary'' means the 
                Secretary of Health and Human Services, acting 
                through the Director of the National Center on 
                Birth Defects and Developmental Disabilities.
                  (B) The term ``State'' 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 the Marshall Islands, and the 
                Republic of Palau.
  (c) Demonstration Program for the Development and 
Establishment of Systemic Mechanisms for the Prevention and 
Treatment of Sickle Cell Disease.--
          (1) Authority to conduct demonstration program.--
                  (A) In general.--The Administrator, through 
                the Bureau of Primary Health Care and the 
                Maternal and Child Health Bureau, shall conduct 
                a demonstration program by making 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, including through--
                          (i) the coordination of service 
                        delivery for individuals with sickle 
                        cell disease;
                          (ii) genetic counseling and testing;
                          (iii) bundling of technical services 
                        related to the prevention and treatment 
                        of sickle cell disease;
                          (iv) training of health 
                        professionals; and
                          (v) identifying and establishing 
                        other efforts related to the expansion 
                        and coordination of education, 
                        treatment, and continuity of care 
                        programs for individuals with sickle 
                        cell disease.
                  (B) Geographic diversity.--The Administrator 
                shall, to the extent practicable, award grants 
                under this section to eligible entities located 
                in different regions of the United States.
          (2) Additional requirements.--An eligible entity 
        awarded a grant under this subsection shall use funds 
        made available under the grant to carry out, in 
        addition to the activities described in paragraph 
        (1)(A), the following activities:
                  (A) To facilitate and coordinate the delivery 
                of education, treatment, and continuity of care 
                for individuals with sickle cell disease 
                under--
                          (i) the entity's collaborative 
                        agreement with a community-based sickle 
                        cell disease organization or a 
                        nonprofit entity that works with 
                        individuals who have sickle cell 
                        disease;
                          (ii) the sickle cell disease newborn 
                        screening program for the State in 
                        which the entity is located; and
                          (iii) the maternal and child health 
                        program under title V of the Social 
                        Security Act (42 U.S.C. 701 et seq.) 
                        for the State in which the entity is 
                        located.
                  (B) To train nursing and other health staff 
                who provide care for individuals with sickle 
                cell disease.
                  (C) To enter into a partnership with adult or 
                pediatric hematologists in the region and other 
                regional experts in sickle cell disease at 
                tertiary and academic health centers and State 
                and county health offices.
                  (D) To identify and secure resources for 
                ensuring reimbursement under the medicaid 
                program, State children's health insurance 
                program, and other health programs for the 
                prevention and treatment of sickle cell 
                disease.
                  (E) To expand, coordinate, and implement 
                transition services for adolescents with sickle 
                cell disease making the transition to adult 
                health care.
          (3) National coordinating center.
                  (A) Establishment. The Administrator shall 
                enter into a contract with an entity to serve 
                as the National Coordinating Center for the 
                demonstration program conducted under this 
                subsection.
                  (B) Activities described. The National 
                Coordinating Center shall--
                          (i) collect, coordinate, monitor, and 
                        distribute data, best practices, and 
                        findings regarding the activities 
                        funded under grants made to eligible 
                        entities under the demonstration 
                        program;
                          (ii) develop a model protocol for 
                        eligible entities with respect to the 
                        prevention and treatment of sickle cell 
                        disease;
                          (iii) develop educational materials 
                        regarding the prevention and treatment 
                        of sickle cell disease; and
                          (iv) prepare and submit to Congress a 
                        final report that includes 
                        recommendations regarding the 
                        effectiveness of the demonstration 
                        program conducted under this subsection 
                        and such direct outcome measures as--
                                  (I) the number and type of 
                                health care resources utilized 
                                (such as emergency room visits, 
                                hospital visits, length of 
                                stay, and physician visits for 
                                individuals with sickle cell 
                                disease); and
                                  (II) the number of 
                                individuals that were tested 
                                and subsequently received 
                                genetic counseling for the 
                                sickle cell trait.
          (4) Application. An eligible entity desiring a grant 
        under this subsection shall submit an application to 
        the Administrator at such time, in such manner, and 
        containing such information as the Administrator may 
        require.
          (5) Definitions. In this subsection:
                  (A) Administrator. The term ``Administrator'' 
                means the Administrator of the Health Resources 
                and Services Administration.
                  (B) Eligible entity. The term ``eligible 
                entity'' means a Federally-qualified health 
                center, a nonprofit hospital or clinic, or a 
                university health center that provides primary 
                health care, that--
                          (i) has a collaborative agreement 
                        with a community-based sickle cell 
                        disease organization or a nonprofit 
                        entity with experience in working with 
                        individuals who have sickle cell 
                        disease; and
                          (ii) demonstrates to the 
                        Administrator that either the 
                        Federally-qualified health center, the 
                        nonprofit hospital or clinic, the 
                        university health center, the 
                        organization or entity described in 
                        clause (i), or the experts described in 
                        paragraph (2)(C), has at least 5 years 
                        of experience in working with 
                        individuals who have sickle cell 
                        disease.
                  (C) Federally-qualified health center. The 
                term ``Federally-qualified health center'' has 
                the meaning given that term in section 
                1905(l)(2)(B) of the Social Security Act (42 
                U.S.C. 1396d(l)(2)(B)).
          (6) Authorization of appropriations. There is 
        authorized to be appropriated to carry out this 
        subsection, $4,455,000 for each of fiscal years 2018 
        through 2022.
  (d) Collaboration With Community-Based Entities.--To be 
eligible to receive a grant or other assistance under 
subsection (b) or (c), an entity must have in effect a 
collaborative agreement with a community-based organization 
with 5 or more years of experience in providing services to 
sickle cell disease patients.

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