[House Report 118-166]
[From the U.S. Government Publishing Office]


118th Congress  }                                            {    Report
                         HOUSE OF REPRESENTATIVES
 1st Session    }                                            { 118-166

======================================================================



 
   SICKLE CELL DISEASE AND OTHER HERITABLE BLOOD DISORDERS RESEARCH, 
          SURVEILLANCE, PREVENTION, AND TREATMENT ACT OF 2023

                                _______
                                

August 25, 2023.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

Mrs. Rodgers of Washington, from the Committee on Energy and Commerce, 
                        submitted the following

                              R E P O R T

                        [To accompany H.R. 3884]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 3884) to amend title XI of the Public Health 
Service Act to reauthorize the program providing for sickle 
cell disease and other heritable blood disorders research, 
surveillance, prevention, and treatment, having considered the 
same, reports favorably thereon with an amendment and 
recommends that the bill as amended do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................     2
Background and Need for Legislation..............................     2
Committee Action.................................................     2
Committee Votes..................................................     3
Oversight Findings and Recommendations...........................     5
New Budget Authority, Entitlement Authority, and Tax Expenditures     5
Congressional Budget Office Estimate.............................     5
Federal Mandates Statement.......................................     5
Statement of General Performance Goals and Objectives............     5
Duplication of Federal Programs..................................     5
Related Committee and Subcommittee Hearings......................     5
Committee Cost Estimate..........................................     6
Earmark, Limited Tax Benefits, and Limited Tariff Benefits.......     6
Advisory Committee Statement.....................................     6
Applicability to Legislative Branch..............................     6
Section-by-Section Analysis of the Legislation...................     6
Changes in Existing Law Made by the Bill, as Reported............     6

    The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

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 2023''.

SEC. 2. REAUTHORIZATION OF SICKLE CELL DISEASE AND OTHER HERITABLE 
                    BLOOD DISORDERS RESEARCH, SURVEILLANCE, PREVENTION, 
                    AND TREATMENT.

  Section 1106(b) of the Public Health Service Act (42 U.S.C. 300b-
5(b)) is amended--
          (1) in paragraph (3)(A), by inserting ``, grant, or 
        cooperative agreement'' after ``contract''; and
          (2) in paragraph (6), by striking ``$4,455,000 for each of 
        fiscal years 2019 through 2023'' and inserting ``$8,205,000 for 
        each of fiscal years 2024 through 2028''.

                          Purpose and Summary

    H.R. 3884 would reauthorize the programs and activities 
under the Centers for Disease Control and Prevention (CDC) and 
the Health Resources and Services Administration (HRSA) aimed 
to support research, prevention, and treatment for sickle cell 
disease and other heritable blood disorders for fiscal years 
2024-2028.

                  Background and Need for Legislation

    The programs reauthorized under the Sickle Cell Disease and 
Other Heritable Blood Disorders Research, Surveillance, 
Prevention, and Treatment Act of 2023 support states' efforts 
to provide services, education, training, and best practices 
related to identification, prevention, and treatment of sickle 
cell disease. Sickle cell disease (SCD) is the most common 
inherited blood disorder in the United States, affecting an 
estimated 100,000 Americans.\1\ People with SCD are born with 
it, though most newborns who have SCD do not have symptoms 
until they are about 5 or 6 months old. SCD is a lifelong 
disease, though there are several innovative new treatments for 
the disease, and one cure through a bone marrow or stem cell 
transplant. This legislation will continue funding for these 
programs with the goal of continuing to improve health 
outcomes.
---------------------------------------------------------------------------
    \1\Centers for Disease Control and Prevention, Data & Statistics on 
Sickle Cell Disease, July 6, 2023.
---------------------------------------------------------------------------

                            Committee Action

    On June 14, 2023, the Subcommittee on Health held a hearing 
on H.R. 3884. The Subcommittee received testimony from:
           Dr. Elizabeth Cherot, MD, MBA, Senior Vice 
        President and Chief Medical Health Officer, March of 
        Dimes;
           Dr. Alexis A. Thompson, MD, MPH, Chief of 
        Division of Hematology, Elias Schwartz MD Endowed Chair 
        in Hematology, Children's Hospital of Philadelphia, 
        Professor of Pediatrics, University of Pennsylvania 
        Perelman School of Medicine;
           Dr. Meredithe McNamara, MD, MS, FAAP, 
        Assistant Professor, Yale School of Medicine;
           Dr. Miriam Grossman, MD, Child, Adolescent, 
        and Adult Psychiatrist;
           Mr. George Manahan, Parkinson's Advocate and 
        Patient; and,
           Mr. Kevin O'Connor, Assistant to the General 
        President for Government Affairs and Political Action, 
        International Association of Fire Fighters.
    On July 13, 2023, the Subcommittee on Health met in open 
markup session and forwarded H.R. 3884, as amended, to the full 
Committee by a record vote of 28 yeas and 0 nays. On July 19, 
2023, the full Committee on Energy and Commerce met in open 
markup session and ordered H.R. 3884, as amended, favorably 
reported to the House by a record vote of 50 yeas and 0 nays.

                            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. The following reflects the record votes taken during 
the Committee consideration:


                 Oversight Findings and Recommendations

    Pursuant to clause 2(b)(1) of rule X and clause 3(c)(1) of 
rule XIII, the Committee held a hearing and made findings that 
are reflected in this report.

           New Budget Authority, Entitlement Authority, and 
                            Tax Expenditures

    Pursuant to clause 3(c)(2) of rule XIII, the Committee 
finds that H.R. 3884 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, at the time this 
report was filed, the cost estimate prepared by the Director of 
the Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974 was not available.

                       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 
reauthorize sickle cell programs and activities under CDC and 
HRSA to support efforts to provide services, education, 
training, and best practices related to identification, 
prevention, and treatment of sickle cell disease.

                    Duplication of Federal Programs

    Pursuant to clause 3(c)(5) of rule XIII, no provision of 
H.R. 3884 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.

              Related Committee and Subcommittee Hearings

    Pursuant to clause 3(c)(6) of rule XIII, the following 
related hearing was used to develop or consider H.R. 3884:
           On June 14, 2023, the Subcommittee on Health 
        held a hearing on H.R. 3884. The Subcommittee received 
        testimony from:
                   Dr. Elizabeth Cherot, MD, MBA, 
                Senior Vice President and Chief Medical Health 
                Officer, March of Dimes;
                   Dr. Alexis A. Thompson, MD, MPH, 
                Chief of Division of Hematology, Elias Schwartz 
                MD Endowed Chair in Hematology, Children's 
                Hospital of Philadelphia, Professor of 
                Pediatrics, University of Pennsylvania Perelman 
                School of Medicine;
                   Dr. Meredithe McNamara, MD, MS, 
                FAAP, Assistant Professor, Yale School of 
                Medicine;
                   Dr. Miriam Grossman, MD, Child, 
                Adolescent, and Adult Psychiatrist;
                   Mr. George Manahan, Parkinson's 
                Advocate and Patient; and,
                   Mr. Kevin O'Connor, Assistant to 
                the General President for Government Affairs 
                and Political Action, International Association 
                of Fire Fighters.

                        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. At the time this report was 
filed, the estimate was not available.

       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. 3884 contains no earmarks, limited 
tax benefits, or limited tariff benefits.

                      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

    Section 1 provides a short title of ``Sickle Cell Disease 
and Other Heritable Blood Disorders Research, Surveillance, 
Prevention, and Treatment Act of 2023''.

Section 2. Reauthorization of sickle cell disease and other heritable 
        blood disorders research, surveillance, prevention, and 
        treatment

    Section 2 amends Title XI of the Public Health Service Act 
to reauthorize the program providing for sickle cell disease 
and other heritable blood disorders research, surveillance, 
prevention, and treatment, for fiscal years 2024 through 2028.

         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 (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italics, and existing law in which no 
change is proposed is shown in roman):

                       PUBLIC HEALTH SERVICE ACT


  TITLE XI--GENETIC DISEASES, HEMOPHILIA PROGRAMS, AND SUDDEN INFANT 
                             DEATH SYNDROME


Part A--Genetic Diseases

           *       *       *       *       *       *       *



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.
  (b) 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 
                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, 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 provide or coordinate 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, grant, or cooperative 
                agreement 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 2019 
        through 2023] $8,205,000 for each of fiscal years 2024 
        through 2028.

           *       *       *       *       *       *       *