[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4866 Introduced in Senate (IS)]
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117th CONGRESS
2d Session
S. 4866
To establish a program to address sickle cell disease and other
heritable hemoglobinopathies.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
September 15, 2022
Mr. Van Hollen (for himself and Mr. Booker) introduced the following
bill; which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To establish a program to address sickle cell disease and other
heritable hemoglobinopathies.
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 ``Sickle Cell Disease Treatment
Centers Act of 2022''.
SEC. 2. ESTABLISHMENT OF SICKLE CELL DISEASE AND OTHER HERITABLE
HEMOGLOBINOPATHIES TREATMENT CENTERS.
Subpart I of part D of title III of the Public Health Service Act
(42 U.S.C. 254b et seq.) is amended by inserting after section 330P (42
U.S.C. 254c-22) the following:
``SEC. 330Q. SICKLE CELL DISEASE AND OTHER HERITABLE HEMOGLOBINOPATHIES
TREATMENT CENTERS.
``(a) Definitions.--In this section:
``(1) Community-based organization.--The term `community-
based organization' means a community-based organization
working in partnership under at least one collaborative
agreement with a medical hub and spoke network.
``(2) Eligible entity.--The term `eligible entity' means
any entity that is a sickle cell disease treatment hub-and-
spoke network that is comprised of--
``(A) a hub-and-spoke network that includes--
``(i) a medical hub that is a hospital,
clinic, or university health center; and
``(ii) at least 1 spoke working in
partnership with the medical hub; and
``(B) at least 1 community-based organization
working in a partnership with the hub-and-spoke
network, or the medical hub or at least one spoke of
such network.
``(3) Hub-and-spoke network.--The term `hub-and-spoke
network' means a framework for delivery of health care
services--
``(A) recommended by the National Academies of
Sciences, Engineering, and Medicine in its 2020 report
titled, `Addressing Sickle Cell Disease: A Strategic
Plan and Blueprint for Action';
``(B) in which a medical hub identifies and manages
a medical spoke or network of spokes, or other
subsidiary entities, to provide comprehensive sickle
cell disease care;
``(C) in which such subsidiary entities serving as
spokes--
``(i) may initially provide limited sickle
cell disease care services; and
``(ii) may evolve into hubs and connect
with new spokes; and
``(D) in which the medical hub and spoke
collaborate with a community-based organization to
extend services and outreach to the sickle cell disease
community.
``(4) Medical hub.--The term `medical hub' means a
hospital, clinic, or university health center that--
``(A) has an outpatient treatment clinic, infusion
capabilities, telehealth capability, and experience
serving individuals living with sickle cell disease;
and
``(B) follows widely acceptable clinical practice
guidelines.
``(5) Spoke.--The term `spoke' means an entity--
``(A) that is--
``(i) a Federally-qualified health center,
as defined in section 1861(aa) of the Social
Security Act;
``(ii) a Federally-qualified health center,
as defined in section 1905(l)(2)(B) of the
Social Security Act; or
``(iii) a hospital, clinic, or university
health center that provides clinical care and
has telehealth capability;
``(B) that has at least 1 collaborative agreement
with a medical hub and a community-based organization;
and
``(C) that incorporates a community health worker
into the care team.
``(b) Program Established.--The Secretary shall award grants to
eligible entities to establish treatment centers using a hub-and-spoke
framework (referred to in this section as `Sickle Cell Disease
Treatment Centers'), for the purposes of--
``(1) promoting access to coordinated longitudinal health
care for all patients with sickle cell disease and individuals
with sickle cell trait;
``(2) providing support to establish integrated health care
teams for patients with sickle cell disease;
``(3) improving the health and well-being of children,
youth, and adults with sickle cell disease;
``(4) increasing reporting on quality and other public
health measures with respect to sickle cell disease treatment;
``(5) accurately compiling all applicable State sickle cell
newborn screening data;
``(6) integrating sickle cell newborn screening data with
longitudinal follow-up data on sickle cell disease health
outcomes and associated complications, in collaboration with
the Sickle Cell Disease Data Collection Program of the Centers
for Disease Control and Prevention; and
``(7) conducting significant public health activities with
respect to sickle cell disease.
``(c) Use of Funds by Eligible Entities.--An eligible entity shall
use grant funds received under this section as follows:
``(1) Medical hub.--The medical hub of the eligible entity
shall carry out the following:
``(A) Operating and administrating costs of
operating a hub-and-spoke framework.
``(B) Complying with published sickle cell disease
treatment guidelines, as identified by the Secretary.
``(C) Educating providers on sickle cell disease
treatment standards and protocols.
``(D) Providing integrated care management, which
may include--
``(i) primary care;
``(ii) care management; and
``(iii) mental health services.
``(E) Coordinating specialty care services, whether
provided at the medical hub or spoke.
``(F) Coordinating reproductive health services for
sickle cell disease patients.
``(G) Providing a dedicated sickle cell expert at
the medical hub to assist in overseeing care of sickle
cell disease patients at spokes and to advise the
community-based organization.
``(H) Educating providers on social determinants of
health and implicit bias that may affect quality of
care and life for patients with sickle cell disease,
trait, or other hemoglobinopathies.
``(I) Providing telehealth appointments to patients
when appropriate and facilitating access to telehealth
services for sickle cell disease patients to the extent
feasible.
``(J) Providing medical and surgical treatment to
sickle cell disease patients.
``(K) Implementing pediatric-to-adult health care
transition programs for purposes of ensuring
coordinated patient graduation from pediatric to adult
providers for all patients.
``(L) Providing social work services in
coordination with a community-based organization.
``(M) Collecting and distributing data as required
by the National Sickle Cell Disease Coordinating Center
established under this section or otherwise required by
the Director of the Centers for Disease Control and
Prevention.
``(N) Engaging in quality improvement with respect
to standards of care for health and quality of life
outcomes among sickle cell disease patients as
identified by the Secretary.
``(2) Community-based organization.--The community-based
organization of the eligible entity shall provide or coordinate
each of the following:
``(A) Providing education and outreach to sickle
cell disease patients, caregivers, and health
providers.
``(B) Providing support in addressing social
determinants of health.
``(C) Providing social work services in
coordination with a medical hub or spoke.
``(D) Testing or coordinating testing for sickle
cell conditions and for carrier states that put a
family at risk for having a child with sickle cell
disease.
``(E) Engaging in quality improvement with respect
to standards of care or health and quality of life
outcomes among sickle cell disease patients, as
identified by the Secretary.
``(3) Spoke.--The spokes of the eligible entity shall
provide or coordinate each of the following services:
``(A) Collaborating with a medical hub to
coordinate and support care for sickle cell disease
patients.
``(B) Providing the approved standards of care for
such patients.
``(C) Providing primary care services or specialty
care.
``(D) Providing telehealth appointments, as
appropriate.
``(E) Providing medical or surgical treatment.
``(F) Implementing individual care plans.
``(G) Providing social work services in
coordination with a community-based organization.
``(H) Collecting and distributing data required by
the National Sickle Cell Disease Coordinating Center
established under this section and the Sickle Cell
Disease Data Collection Program of the Centers for
Disease Control and Prevention.
``(4) Additional uses of funds.--In addition to the uses of
funds described in paragraphs (1), (2), and (3), an eligible
entity selected to receive a grant under this section may use
funds received through the grant--
``(A) to identify and secure resources for ensuring
reimbursement under, for the State involved, the State
plan under title XIX of the Social Security Act (or a
waiver of such plan), State child health plan under
title XXI of such Act (or a waiver of such plan), and
other health programs for the prevention and treatment
of sickle cell disease, including by working with
community-based sickle cell disease organizations and
other nonprofit entities;
``(B) to assist sickle cell disease patients with
accessing appropriate health care insurance,
including--
``(i) through the payment of insurance
premiums and cost-sharing amounts, to the
extent otherwise permitted under State and
Federal law;
``(ii) by working with community-based
sickle cell disease organizations and other
nonprofit entities; and
``(iii) by helping sickle cell disease
patients know their rights with insurance
programs;
``(C) to facilitate access to telehealth services
for sickle cell disease patients to the extent
feasible;
``(D) to fund evidence-based programs that provide
education to teachers and school personnel,
correctional institution personnel, and health care
professionals on the care of individuals with sickle
cell disease in health care settings and other
appropriate settings, including schools and prisons;
``(E) to offer transportation services for sickle
cell disease patients who do not have, but who need
access to in-person care with the Sickle Cell Disease
Treatment Centers; and
``(F) to facilitate access to sickle cell trait
testing and genetic counseling.
``(d) Application; Selection.--
``(1) Application.--An eligible entity desiring a grant
under this section shall submit an application to the Secretary
at such time, in such manner, and containing such information
as the Secretary may require, including a description of how
the hub-and-spoke entity and community-based organization will
collaborate in carrying out the activities described in
subsection (c). Such an application may be submitted on behalf
of the eligible entity by a hub-and-spoke network or by the
community-based organization.
``(2) Geographic distribution.--The Secretary, acting
through the Administrator of the Health Resources and Services
Administration, shall award grants under this section, to the
extent practicable, to eligible entities located across the
United States, with a focus on regions where a disproportionate
number of patients with sickle cell disease or other heritable
hemoglobinopathy patients per capita reside, and with the
intention of awarding grants nationwide so that patients can
access more comprehensive sickle cell disease treatment
services no matter where they reside.
``(3) Priorities in making awards.--In awarding grants
under this section, the Secretary may give priority to eligible
entities that--
``(A) include at least one historically black
college or university (defined as a part B institution
under section 322 of the Higher Education Act of 1965
(20 U.S.C. 1061)) or minority serving institution
(defined as an eligible institution under section 371
of such Act (20 U.S.C. 1067q)) that has a medical
school;
``(B) serve an area with a prevalence of sickle
cell disease; or
``(C) serve a rural area.
``(4) Eligible patients.--For purposes of this section,
patients who may be treated by Sickle Cell Disease Treatment
Centers, or who may be supported by public health activities
and other programming, shall include patients with sickle cell
disease, and may include patients with other heritable
hemoglobinopathies.
``(e) National Sickle Cell Disease Coordinating Center.--
``(1) In general.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration, shall enter into a contract with an entity to
serve as the National Sickle Cell Disease Coordinating Center,
which shall coordinate the activities conducted by grantees
under this section and carry out the activities described in
paragraph (2).
``(2) Duties.--The National Sickle Cell Disease
Coordinating Center shall carry out each of the following
activities:
``(A) Coordinate the infrastructure of Sickle Cell
Disease Treatment Centers established under subsection
(b).
``(B) Coordinate and support hub-and-spoke
frameworks.
``(f) CDC Sickle Cell Disease Data Collection Program for SCD
Treatment Centers.--The Secretary, acting through the Director of the
Centers for Disease Control and Prevention, shall coordinate the
following with respect to eligible entities under this section:
``(1) Collecting, coordinating, monitoring, and
distributing data, best practices, and findings regarding the
activities funded under grants made to eligible entities under
this section.
``(2) Collecting and maintaining up-to-date data on sickle
cell disease and sickle cell trait, including subtypes as
applicable, and their associated health outcomes and
complications, including for the purpose of--
``(A) improving national incidence and prevalence
data, including the geographic distribution of affected
individuals;
``(B) working with the State newborn screening
programs to establish a national registry of sickle
cell newborn screening data to serve as a foundation
for assessing longevity and the prevalence of
complications resulting from sickle cell disease;
``(C) identifying health disparities impacting
individuals born with sickle cell disease and sickle
cell trait, including subtypes as applicable, and other
hemoglobinopathies;
``(D) assessing the utilization of therapies,
comprehensive complication risk screening, and
strategies to prevent complications resulting from
sickle cell disease and to increase quality of life;
and
``(E) evaluating the effects of genetic,
environmental, behavioral, and other risk factors that
may affect individuals with sickle cell disease.
``(3) Developing educational materials, public awareness
campaigns, or other outreach programs regarding the prevention
and treatment of sickle cell disease and the prevalence of
sickle cell trait.
``(4) Preparing and submitting to Congress a final report
that includes recommendations regarding the effectiveness of
the Sickle Cell Disease Treatment Centers established under
subsection (b) and direct outcome measures, including--
``(A) 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
``(B) the number of individuals that were tested
and subsequently received genetic counseling for the
sickle cell trait.
``(g) Request for Information.--Not later than 180 days after the
date of enactment of the Sickle Cell Disease Treatment Centers Act of
2022, and in advance of each new grant cycle thereafter, the Secretary
shall publish in the Federal Register a request for information seeking
feedback from stakeholders on--
``(1) best practices with respect to the establishment and
implementation of Sickle Cell Disease Treatment Centers; and
``(2) any other information that the Secretary may require.
``(h) Report to Congress.--
``(1) In general.--Not later than 3 years after the date of
the enactment of the Sickle Cell Disease Treatment Centers Act
of 2022 and every 5 years thereafter, the Secretary shall
submit to Congress a report on the impact of the Sickle Cell
Disease Treatment Centers established under this section on
health outcomes for sickle cell disease patients.
``(2) Report elements.--The report described in this
section shall include--
``(A) a summary and description of eligible
entities operating a hub-and-spoke framework that are
receiving grant funds under this section;
``(B) information about the specific activities
supported by grant funds awarded under this section
with respect to each eligible entity; and
``(C) the number of sickle cell disease patients
served by grant programs funded under this section and
demographic information about those patients, including
race, sex, gender, geographic location, and age.
``(i) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section, $535,000,000 for fiscal year
2023 and each fiscal year thereafter. Of the amount made available for
a fiscal year under the preceding sentence, not less than--
``(1) 70 percent shall be used to award grants to at least
128 eligible entities where the application is submitted by
medical hubs or spokes;
``(2) 20 percent shall be used to award grants to at least
100 eligible entities where the application is submitted by
community-based sickle cell disease organizations or nonprofit
entities that are part of an eligible entity;
``(3) 5 percent shall be used for the establishment and
maintenance of the National Sickle Cell Disease Coordinating
Center described in subsection (e); and
``(4) 5 percent shall be used for the activities of the
Sickle Cell Data Collection program of the Centers for Disease
Control and Prevention described in this section.''.
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