New Era of Preventing End-Stage Kidney Disease Act
Bill: H.R.7506 | Sponsor: Rep. Butterfield, G. K. (D-NC)
Policy area: Health

Summary:
New Era of Preventing End-Stage Kidney Disease Act
This bill addresses rare kidney diseases through research, training for health professionals, and other means. It also modifies requirements for Medicare drug plan formularies that include drugs for rare diseases or conditions.
The Department of Health and Human Services (HHS) must
HHS may award grants to educate and train health professionals about kidney disease and nephrology. Additionally, health professional schools that receive certain HHS funding for educating underrepresented minority individuals must support postgraduate nephrology training.
The National Institutes of Health (NIH) must report on diversity in its kidney disease research. The NIH may also (1) support research on rare kidney diseases that, among other requirements, includes persons of color in study populations; and (2) establish regional centers of excellence for rare kidney diseases.
The Centers for Medicare & Medicaid Services must evaluate methods for (1) treating rare kidney diseases, with a focus on delaying dialysis and transplant; and (2) raising awareness about rare kidney diseases, including in communities of color.
Furthermore, if a Medicare drug plan formulary includes a drug to treat a rare disease or condition, at least two members of the committee that develops or reviews the formulary must have expertise in the field of medicine related to that drug.

To amend the Public Health Service Act with respect to preventing end-
             stage kidney disease, and for other purposes.

    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 ``New Era of Preventing End-Stage 
Kidney Disease Act''.

SEC. 2. TABLE OF CONTENTS.

    The table of contents of this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Findings.
Sec. 4. Definitions.
    TITLE I--CENTERS OF EXCELLENCE AND RARE KIDNEY DISEASE RESEARCH

Sec. 101. NIDDK Centers on Rare Kidney Disease Research.
Sec. 102. Rare kidney disease progression research.
                         TITLE II--DIAGNOSTICS

Sec. 201. Diagnostic issues relating to rare kidney disease.
                    TITLE III--COMMUNITIES OF COLOR

Sec. 301. Understanding and slowing the progression of rare kidney 
                            disease and treatment in certain 
                            populations.
Sec. 302. Communities of color service program.
Sec. 303. NIH report on NIH research programs.
Sec. 304. Partnerships with organizations and agencies.
                      TITLE IV--PROVIDER EDUCATION

Sec. 401. Primary care provider training grant program.
Sec. 402. Grant program for development and implementation of curricula 
                            for continuing education on kidney disease.
  TITLE V--COVERAGE AND EXPERIMENTS TO REDUCE DIALYSIS AND TRANSPLANT 
                                 COSTS

Sec. 501. Medical expertise in pharmacy and therapeutic committees.
Sec. 502. Reducing dialysis and transplant costs related to rare kidney 
                            disease.

SEC. 3. FINDINGS.

    Congress finds the following:
            (1) Approximately 37,000,000 adults in the United States 
        have a chronic kidney disease, and kidney diseases are the 
        ninth leading cause of death in the United States.
            (2) Each day in the United States, on average, 340 people 
        begin dialysis and 13 people die waiting for a kidney 
        transplant.
            (3) Rare kidney diseases like focal segmental 
        glomerulosclerosis and immunoglobulin A nephropathy are 
        particularly difficult to treat, and there are no approved 
        treatments for these diseases.
            (4) In the absence of approved treatment options, more than 
        100,000 people live with rare glomerular kidney disease and 
        face dialysis, transplant, or death.
            (5) Focal segmental glomerulosclerosis is associated with a 
        50 percent risk of end-stage kidney disease within 5 years of 
        diagnosis if partial or complete remission is not achieved.
            (6) Between 20 and 40 percent of individuals with 
        immunoglobulin A nephropathy are expected to develop end-stage 
        kidney disease within 20 years.
            (7) Rare kidney diseases disproportionately affect Black 
        Americans, who are 3.5 times more likely to develop end-stage 
        kidney disease, and 5 times more likely than the general 
        population to have focal segmental glomerulosclerosis.
            (8) Because approximately one-third of Black Americans with 
        focal segmental glomerulosclerosis cases are associated with a 
        particular gene, communities of color would benefit from 
        additional resources to support earlier detection, including 
        genetic and genomic testing and referrals to high-quality 
        providers.
            (9) The prevalence of end-stage kidney disease is 
        exacerbated by diagnostic challenges, barriers to high-quality 
        care, and lack of awareness of disease risks.
            (10) Federal spending on end-stage kidney disease currently 
        accounts for approximately 7 percent of Federal Medicare 
        spending.
            (11) The total Medicare spending on both chronic kidney 
        disease and end-stage kidney disease patients exceeded 
        $120,000,000,000 per year in recent years.
            (12) A focus on renal health and the prevention of end-
        stage kidney disease would improve patient outcomes, extend 
        lives, mitigate racial health care disparities, and reduce 
        government spending.
            (13) Due in large part to the 21st Century Cures Act, new 
        regulatory paradigms have unleashed a wave of clinical 
        innovation in the rare kidney disease space.
            (14) In 2020, the first-ever Rare Kidney Disease Roundtable 
        outlined urgent needs in the areas of diagnosis, education, 
        communities of color, and patient support for rare kidney 
        disease patients and their families in the United States.
            (15) In 2021, there are over 30 ongoing clinical trials 
        underway for treatments for a range of rare kidney diseases, 
        offering the first hope for novel therapies for patients living 
        with rare kidney diseases, a new era of preventing end-stage 
        kidney disease and related Federal costs, and the possibility 
        of improving chronic kidney care writ large.

SEC. 4. DEFINITIONS.

    In this Act:
            (1) Director of nih.--The term ``Director of NIH'' means 
        the Director of the National Institutes of Health.
            (2) NIH.--The term ``NIH'' means the National Institutes of 
        Health.
            (3) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.

    TITLE I--CENTERS OF EXCELLENCE AND RARE KIDNEY DISEASE RESEARCH

SEC. 101. NIDDK CENTERS ON RARE KIDNEY DISEASE RESEARCH.

     Subpart 3 of part C of title IV of the Public Health Service Act 
(42 U.S.C. 281 et seq.) is amended by inserting after section 426 (42 
U.S.C. 285c) the following new section:

``SEC. 426A. NIDDK CENTERS ON RARE KIDNEY DISEASE RESEARCH.

    ``(a) Cooperative Agreements and Grants.--
            ``(1) In general.--The Director of the Institute may enter 
        into cooperative agreements with, and make grants to, public 
        and private nonprofit entities to pay all or part of the cost 
        of planning, establishing, or strengthening, and providing 
        basic operating support for, regional centers of excellence for 
        rare kidney diseases, including primary glomerular disease. 
        Such centers of excellence shall be known as NIDDK Centers on 
        Rare Kidney Disease Research.
            ``(2) Purposes of centers.--The purposes of the centers of 
        excellence funded pursuant to paragraph (1) shall be--
                    ``(A) to increase public awareness of rare kidney 
                diseases, particularly in communities of color; and
                    ``(B) to develop resources for clinical research 
                into, training in, and demonstration of diagnostic, 
                prevention, control, and treatment methods for, rare 
                kidney diseases.
            ``(3) Policies.--A cooperative agreement or grant under 
        paragraph (1) shall be entered into in accordance with policies 
        established by the Director of the National Institutes of 
        Health.
    ``(b) Coordination With Other Institutes.--The Director of the 
Institute shall coordinate the activities under this section with 
similar activities that are related to rare kidney disease and 
conducted by other national research institutes, centers, and agencies 
of the National Institutes of Health and by the Food and Drug 
Administration.
    ``(c) Uses for Federal Payments Under Cooperative Agreements or 
Grants.--Federal payments made under a cooperative agreement or grant 
under subsection (a) may be used for--
            ``(1) basic operating costs, including such patient care 
        costs as are required for research;
            ``(2) clinical training, including training for allied 
        health professionals, continuing education for health 
        professionals and allied health professions personnel, and 
        information programs for the public with respect to rare kidney 
        diseases;
            ``(3) clinical research and demonstration programs;
            ``(4) education of members of the public, particularly 
        through outreach to communities of color, on the diagnosis 
        (including through routine urinalysis and through genetic 
        testing), prevention, control, and treatment of rare kidney 
        diseases; and
            ``(5) education of individuals diagnosed with rare kidney 
        diseases on renal diet and lifestyle, genetic testing, and 
        programs to promote urinalysis, and on mental and emotional 
        health resources for families of rare kidney disease patients.
    ``(d) Period of Support; Additional Periods.--The period of support 
for a center of excellence under subsection (a) may not exceed 5 years, 
except that such period may be extended by the Director of the 
Institute for additional periods of not more than 5 years for each 
center if--
            ``(1) the operations of such center have been reviewed by 
        an appropriate technical and scientific peer review group 
        established by the Director of the Institute; and
            ``(2) such group has recommended to the Director of the 
        Institute that such period should be extended.
    ``(e) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $4,000,000 for each of fiscal 
years 2023 through 2027.''.

SEC. 102. RARE KIDNEY DISEASE PROGRESSION RESEARCH.

    (a) NIH Research on Rare Kidney Diseases.--The Director of NIH may 
award grants or contracts to public and nonprofit private entities to 
conduct research on the causes, etiology, symptoms, diagnosis, 
progression, and treatment of rare kidney diseases, including 
glomerular diseases.
    (b) Application.--To seek a grant under this section, an eligible 
entity shall submit an application in such form, in such manner, and 
containing such agreements, assurances, and information as the Director 
of NIH determines to be necessary.
    (c) Research Funded.--Research funded through a grant under this 
section--
            (1) may not include any consideration of quality-adjusted 
        life years or disability-adjusted life years, or other similar 
        mechanisms that discriminate against people with disabilities 
        in value and cost-effectiveness assessments;
            (2) shall include persons of color in populations studied 
        in the research; and
            (3) shall include study of genotype-phenotype relation to 
        disease progression.
    (d) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $1,000,000 for each of fiscal 
years 2023 through 2027.

                         TITLE II--DIAGNOSTICS

SEC. 201. DIAGNOSTIC ISSUES RELATING TO RARE KIDNEY DISEASE.

    (a) Conference.--
            (1) In general.--The Secretary shall, not later than 12 
        months after the date of the enactment of this Act, convene a 
        conference to--
                    (A) analyze the impact of the decline of routine 
                urinalysis on the timely diagnosis of rare kidney 
                disease and on the quality of patient care following a 
                diagnosis of such disease;
                    (B) analyze the quality and reliability of kidney 
                biopsy in the diagnosis of rare kidney disease;
                    (C) analyze the impact of genetic and genomic 
                testing on preventative care and precision medicine 
                with respect to rare kidney disease;
                    (D) recommend strategies to reduce disparities in 
                the occurrence and treatment of rare kidney disease 
                among different groups, including communities of color; 
                and
                    (E) recommend strategies to increase routine 
                urinalysis and to improve technologies to diagnose such 
                disease, including genetic testing.
            (2) Consultation.--In carrying out paragraph (1), the 
        Secretary shall consult with relevant stakeholders, including 
        health care providers, medical professional societies, State-
        based societies, public health experts, State and local public 
        health departments, State medical boards, patient groups, drug 
        manufacturers, pharmacists, insurers, and other entities with 
        experience in health care, public health, and rare disease, as 
        appropriate.
    (b) Early Intervention on Genetic Screening.--
            (1) Study.--The Secretary shall conduct a study on--
                    (A) whether genetic and genomic testing may improve 
                preventative care and precision medicine with respect 
                to rare kidney disease;
                    (B) whether genetic and genomic testing, and in 
                particular testing of the APOL1 gene, may reduce 
                disparities in the occurrence and treatment of rare 
                kidney disease among different groups, including 
                communities of color;
                    (C) whether the Federal Government may help to 
                reduce barriers to genetic and genomic testing for rare 
                kidney disease, including by--
                            (i) encouraging the expansion of health 
                        insurance coverage of genetic and genomic 
                        testing, including diagnostic, predictive, and 
                        presymptomatic testing, and DNA sequencing 
                        clinical services;
                            (ii) supporting the collection of evidence 
                        for the clinical utility and appropriate use of 
                        genetic and genomic tests; and
                            (iii) improving access to genetic 
                        counselors, pathologists, and other relevant 
                        professions, including strengthening related 
                        workforce education and training efforts;
                    (D) the extent to which coverage provisions in the 
                Medicare and Medicaid programs under titles XVIII and 
                XIX of the Social Security Act (42 U.S.C. 1395 et seq., 
                1396 et seq.) may restrain the use of genetic and 
                genomic testing for rare kidney disease that may 
                improve clinical outcomes for beneficiaries;
                    (E) whether the Centers for Medicare & Medicaid 
                Services may make coverage determinations that better 
                suit a precision medicine approach to treatment; and
                    (F) whether genetic and genomic testing may improve 
                health outcomes for individuals with rare kidney 
                disease.
            (2) Report.--
                    (A) In general.--Not later than 18 months after the 
                date of the enactment of this Act, the Secretary shall 
                submit a report to the Congress on the proceedings of 
                the conference under subsection (a) and the results of 
                the study under paragraph (1).
                    (B) Consultation.--In conducting the study under 
                paragraph (1) and developing the report required by 
                subparagraph (A), the Secretary shall consult with 
                physicians, other health professionals, health 
                educators, health professional organizations, relevant 
                companies, patients, patient organizations, the Health 
                Resources and Services Administration, the Director of 
                NIH, the National Institute of Diabetes and Digestive 
                and Kidney Diseases, and the Centers for Medicare & 
                Medicaid Services. Such consultation shall include 
                consultation activities conducted as part of the 
                conference under subsection (a).
            (3) Definition.--In this subsection, the term ``DNA 
        sequencing clinical services'', with respect to an individual--
                    (A) means a determination of an exact sequence of 
                deoxyribonucleic acid bases in the genome of such 
                individual, and, if for the sole benefit of the 
                individual, a biological parent of such individual for 
                the purpose of determining whether one or more 
                potentially disease-causing genetic variants are 
                present in the genome of such individual or such 
                biological parent; and
                    (B) includes--
                            (i) sequencing of the entire genome, of the 
                        exome, of a panel of genes, or other regions of 
                        the genome; and
                            (ii) any analysis, interpretation, and data 
                        report derived from such sequencing.
    (c) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $5,000,000 for the period of 
fiscal years 2023 through 2027.

                    TITLE III--COMMUNITIES OF COLOR

SEC. 301. UNDERSTANDING AND SLOWING THE PROGRESSION OF RARE KIDNEY 
              DISEASE AND TREATMENT IN CERTAIN POPULATIONS.

    (a) Study.--The Secretary shall conduct a study on--
            (1) the social, behavioral, and biological factors leading 
        to rare kidney disease;
            (2) treatment patterns associated with providing care, 
        under the Medicare program under title XVIII of the Social 
        Security Act (42 U.S.C. 1395 et seq.), the Medicaid program 
        under title XIX of such Act (42 U.S.C. 1396 et seq.), and 
        through private health insurance, to populations that are 
        disproportionately affected by such disease;
            (3) access to nephrologists among populations that are 
        disproportionately affected by such disease;
            (4) ongoing efforts and recommendations to slow the 
        progression of end-stage kidney disease in populations that are 
        disproportionately affected by rare kidney disease; and
            (5) patient trust of treating providers among populations 
        that are disproportionately affected by such disease.
    (b) Report.--Not later than 1 year after the date of the enactment 
of this Act, the Secretary shall submit to the Congress a report on the 
study conducted under subsection (a), together with such 
recommendations as the Secretary determines to be appropriate.
    (c) Coordination.--In carrying out the activities under subsections 
(a) and (b), the Secretary shall coordinate with the Director of NIH, 
the Administrator of the Center for Medicare & Medicaid Services, the 
Administrator of the Health Resources and Services Administration, and 
the Director of the Center for Medicare and Medicaid Innovation.
    (d) Consultation.--In carrying out the activities under subsections 
(a) and (b), the Secretary shall consult with relevant stakeholders, 
including health care providers, medical professional societies, State-
based societies, public health experts, State and local public health 
departments, State medical boards, patient groups, drug manufacturers, 
pharmacists, insurers, and other entities with experience in health 
care, public health, health equity, and rare disease, as appropriate.

SEC. 302. COMMUNITIES OF COLOR SERVICE PROGRAM.

    Section 736(b) of the Public Health Service Act (42 U.S.C. 293) is 
amended--
            (1) by redesignating paragraph (7) as paragraph (8);
            (2) in paragraph (6)(B), by striking ``; and'' and 
        inserting a semicolon; and
            (3) by inserting after paragraph (6) the following:
            ``(7) to award fellowships, which may include stipends, for 
        postgraduate training in the field of nephrology, for the 
        purposes of--
                    ``(A) increasing providers' knowledge of issues 
                related to prevention, diagnosis, and treatment of rare 
                kidney disease among racial and ethnic minority 
                populations, especially the prevalence of the gene 
                APOL1;
                    ``(B) improving the quality of rare kidney disease 
                prevention, diagnosis, and treatment delivered to 
                racial and ethnic minorities; and
                    ``(C) increasing the number of culturally competent 
                nephrologists; and''.

SEC. 303. NIH REPORT ON NIH RESEARCH PROGRAMS.

    The Director of NIH shall prepare and publish on the public website 
of the agency a report on diversity within the programs of the NIH to 
research kidney disease, including--
            (1) the diversity of recipients of research grants; and
            (2) the extent to which grants are awarded to research 
        kidney disease among communities of color, including 
        disparities in the prevention, diagnosis, and treatment of 
        kidney disease among racial and ethnic minority populations.

SEC. 304. PARTNERSHIPS WITH ORGANIZATIONS AND AGENCIES.

    (a) HHS Program.--Under this section or other applicable provisions 
of law, the Secretary shall establish a program to provide grants to 
eligible entities to provide education and appropriate medical and 
other referrals for patients in communities of color regarding kidney 
disease, including rare kidney disease.
    (b) Eligibility.--To be eligible to receive a grant under this 
section, an entity shall--
            (1) be--
                    (A) a nonprofit or community-based organization, 
                including any community health center; or
                    (B) a State or local governmental agency; and
            (2) submit to the Secretary an application--
                    (A) at such time and in such manner as the 
                Secretary may require; and
                    (B) containing--
                            (i) a description of how the applicant 
                        proposes to use the grant funds; and
                            (ii) such other information as the 
                        Secretary may require.
    (c) Reporting.--
            (1) By grantee.--A recipient of a grant under this section 
        shall submit annually to the Secretary, and make publicly 
        available, a report on the activities conducted using funds 
        received through the grant.
            (2) By secretary.--Not later than the end of fiscal year 
        2026, the Secretary shall submit to the Congress a report that 
        includes--
                    (A) a summary of the reports received under 
                paragraph (1);
                    (B) an evaluation of the effectiveness of grants 
                awarded under this section; and
                    (C) any recommendations the Secretary may have.
    (d) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $2,000,000 for each of fiscal 
years 2023 through 2027.

                      TITLE IV--PROVIDER EDUCATION

SEC. 401. PRIMARY CARE PROVIDER TRAINING GRANT PROGRAM.

    Subpart I of part C of title VII of the Public Health Service Act 
(42 U.S.C. 293k et seq.) is amended by inserting after section 747A (42 
U.S.C. 293k-1) the following:

``SEC. 747B. RARE KIDNEY DISEASE TRAINING FOR PRIMARY CARE PROVIDERS.

    ``(a) In General.--The Secretary may make grants to an accredited 
public or nonprofit private hospital, school of medicine, or 
academically affiliated physician assistant training program, to a 
public or private nonprofit entity that the Secretary has determined is 
capable of carrying out such grant, or to any consortium of such 
hospitals, schools, programs, or entities, to plan, develop, and 
operate a professional training program in the field of nephrology for 
primary care residents, physicians, physician assistants, or nurse 
practitioners, on--
            ``(1) methods to detect and diagnose rare kidney disease, 
        including urinalysis and genetic testing;
            ``(2) implementing such diagnostic methods in their 
        practices;
            ``(3) establishing treatment protocols for individuals 
        diagnosed with rare kidney disease; and
            ``(4) implementing a collaborative care model to coordinate 
        care of patients diagnosed with rare kidney disease among 
        health care providers.
    ``(b) Priorities in Making Awards.--In awarding grants under this 
section, the Secretary may give priority to qualified applicants that--
            ``(1) have a record of training primary care providers;
            ``(2) establish formal relationships and submit joint 
        applications with Federally qualified health centers, rural 
        health clinics, or clinics located in underserved areas or that 
        serve underserved populations; or
            ``(3) teach trainees the skills to provide 
        interprofessional, integrated care through collaboration among 
        health professionals, including specialists.
    ``(c) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section $800,000 for each of fiscal 
years 2023 through 2027.''.

SEC. 402. GRANT PROGRAM FOR DEVELOPMENT AND IMPLEMENTATION OF CURRICULA 
              FOR CONTINUING EDUCATION ON KIDNEY DISEASE.

    Part C of title VII of the Public Health Service Act (42 U.S.C. 
293k et seq.) is amended--
            (1) in the part heading, by striking ``and pediatric 
        dentistry'' and inserting ``pediatric dentistry, and kidney 
        disease''; and
            (2) by inserting after subpart II (42 U.S.C. 293m) the 
        following:

         ``Subpart III--Continuing Education in Kidney Disease

``SEC. 749C. CURRICULA FOR CONTINUING EDUCATION ON KIDNEY DISEASE.

    ``(a) Grants.--The Secretary may award grants to eligible entities 
for the development and implementation of curricula for providing 
continuing education and training to health care professionals on 
identifying, referring, and treating individuals with kidney disease.
    ``(b) Eligible Entities.--To be eligible to seek a grant under this 
section, an entity shall be a public or nonprofit entity that--
            ``(1) provides continuing education or training to health 
        care professionals; or
            ``(2) applies for the grant in partnership with another 
        entity that provides such education and training.
    ``(c) Preference.--In awarding grants under this section, the 
Secretary shall give preference to eligible entities proposing to 
develop and implement curricula for providing continuing education and 
training to--
            ``(1) primary care providers; or
            ``(2) health care professionals who are required, as a 
        condition of State licensure, to participate in continuing 
        education or training.
    ``(d) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $1,600,000 for each of fiscal 
years 2023 through 2027.''.

  TITLE V--COVERAGE AND EXPERIMENTS TO REDUCE DIALYSIS AND TRANSPLANT 
                                 COSTS

SEC. 501. MEDICAL EXPERTISE IN PHARMACY AND THERAPEUTIC COMMITTEES.

    Section 1860D-4(b)(3)(A) of the Social Security Act (42 U.S.C. 
1395w-104(b)(3)(A)) is amended by striking clause (ii) and inserting 
the following:
                            ``(ii) Inclusion of independent experts.--
                        Such committee shall include--
                                    ``(I) at least one practicing 
                                physician and at least one practicing 
                                pharmacist, each of whom--
                                            ``(aa) is independent and 
                                        free of conflict with respect 
                                        to the sponsor and plan; and
                                            ``(bb) has expertise in the 
                                        care of elderly or disabled 
                                        persons; and
                                    ``(II) in the case of a drug 
                                approved to treat a rare disease or 
                                condition as defined in section 526 of 
                                the Federal Food, Drug, and Cosmetic 
                                Act (21 U.S.C. 360bb), at least two 
                                members that meet the requirements 
                                described in items (aa) and (bb) of 
                                subclause (I) and have expertise in the 
                                field of medicine related to that 
                                drug.''.

SEC. 502. REDUCING DIALYSIS AND TRANSPLANT COSTS RELATED TO RARE KIDNEY 
              DISEASE.

    Section 1881(f) of the Social Security Act (42 U.S.C. 1395rr(f)) is 
amended by adding at the end the following new paragraph:
    ``(9)(A) The Secretary shall conduct experiments to evaluate 
methods for treating rare kidney disease, giving particular attention 
to treatments that would delay or eliminate the need for dialysis and 
transplant.
    ``(B) The Secretary shall conduct a comprehensive study of methods 
to increase public awareness of rare kidney disease, including in 
communities of color.
    ``(C) The Secretary shall submit to Congress, not later than 24 
months after the date of the enactment of the New Era of Preventing 
End-Stage Kidney Disease Act, a report on the experiments and study 
conducted under subparagraphs (A) and (B). Such report shall include 
recommendations for legislative changes that the Secretary finds 
necessary or desirable as a result of such experiments and study.''.
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