[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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