II 118th CONGRESS 1st Session S. 2560 IN THE SENATE OF THE UNITED STATES July 27, 2023 Mr. Kaine (for himself and Mr. Young ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To address and support research on Long COVID.

1. Short title This Act may be cited as the Long COVID Support Act . 2. Voluntary patient registry for research on Long COVID and related conditions (a) In general The Secretary of Health and Human Services (referred to in this Act as the Secretary ) shall carry out activities described in subsection (b) for treatment related to Long COVID and related conditions. (b) Activities described For purposes of subsection (a), activities described in this subsection shall include— (1) creating or maintaining a regularly updated voluntary patient registry of individuals with suspected or confirmed Long COVID and related conditions, including information on— (A) symptoms that arise while an individual is initially infected with COVID–19 and that may resolve over time or extend beyond the resolution of the initial symptoms; (B) persistent symptoms that arise after an individual is initially infected with COVID–19 and that the clinician of such individual has reason to suspect were related to the COVID–19 diagnosis; (C) symptoms that arise in an individual that may be related to COVID–19, but a diagnosis of COVID–19 was not obtained and cannot be identified due to a lack of antibodies, false negative test results, or lack of access to timely testing; (D) treatments of individuals after primary diagnosis of COVID–19 and the effectiveness of such treatments; (E) any other relevant questions or issues related to individuals who experience a diagnosis of, treatment for, and management of care with COVID–19, Long COVID, and related conditions; and (F) comorbidities, vaccination status, and demographics, including age, gender, race and ethnicity, geographic location, and occupation of registry participants; (2) information relating to individuals experiencing Long COVID and related conditions and other information available through the voluntary patient registry; (3) dissemination of information to relevant Federal departments and agencies and patients participating in the voluntary patient registry related to COVID–19, Long COVID, and related conditions; (4) an assurance that the voluntary patient registry utilizes common data elements and definitions for use in order to promote appropriate data sharing for ongoing and future research; and (5) outreach to, and inclusion in the voluntary patient registry, as appropriate, of individuals from communities impacted by high COVID–19 and Long COVID rates and health care providers from diverse disciplines that may treat individuals with COVID–19, Long COVID, and related conditions. (c) Voluntary participation; privacy protections (1) Voluntary participation Participation in the patient registry described in subsection (b)(1) shall be voluntary, and a person creating, assisting in the creation of, or maintaining the registry shall not include in the registry information about an individual unless the individual consents to the inclusion of such information. (2) Privacy protections Information about an individual that is included in the registry shall be subject to all applicable privacy protections under Federal and State law. (d) Report Not later than 1 year after the establishment of the patient registry under subsection (b)(2), and annually thereafter, the Secretary shall submit a report that includes data, findings, and information with respect to the status of the patient registry (including progress, barriers, and issues) to Congress and the President. 3. Research and coordination of activities concerning the long-term health effects of Long COVID and related conditions (a) In general The Secretary of Health and Human Services (referred to in this section as the Secretary ) shall, as appropriate— (1) coordinate activities among relevant Federal departments and agencies with respect to addressing the long-term health effects of Long COVID and related conditions, which may include conditions that arise as a result of such infection; (2) continue to conduct or support basic, clinical, epidemiological, behavioral, and translational research and public health surveillance related to the pathogenesis, prevention, diagnosis, and treatment of the long-term health effects of Long COVID and related conditions, which may include conditions and any effects on development, cognition, and neural structure and function that arise as a result of such infection; and (3) consistent with the findings of studies and research under paragraph (1), in consultation with health and public health professional associations, scientific and medical researchers, and other relevant experts, develop and inform recommendations, guidance, and educational materials on the long-term effects of Long COVID and related conditions, which may include conditions that arise as a result of such infection, and provide such recommendations, guidance, and educational materials to health care providers and the general public. (b) Considerations In conducting or supporting research under this section, the Secretary shall consider the diversity of research participants or cohorts to ensure inclusion of a broad range of participants, as applicable and appropriate. (c) Additional activities The Secretary may— (1) acting through the Director of the Agency for Healthcare Research and Quality, conduct or support research related to— (A) the improvement of health care delivery for individuals experiencing long-term health effects of Long COVID and related conditions, which may include conditions that arise as a result of such infection; (B) the identification of any trends associated with differences in diagnosis and treatment of the long-term health effects of Long COVID and related conditions; and (C) the development or identification of tools and strategies to help health care entities and providers care for such populations, which may include addressing any differences identified pursuant to subparagraph (B); (2) publicly disseminate the results of such research; and (3) establish a primary care technical assistance initiative to convene primary care providers and organizations, which may include support for continuing training and education for such providers, as applicable and appropriate, in order to collect and disseminate best practices related to the care of individuals with long-term health effects of Long COVID and related conditions. (d) Annual reports Not later than 1 year after the date of enactment of this Act, and annually thereafter for the next 4 years, the Secretary shall prepare and submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives regarding an overview of the research conducted or supported under this section and any relevant findings. Such reports may include information about how the research and relevant findings under this section relate to other research efforts supported by other public or private entities. (e) Public availability of information In making information or reports publicly available under this section, the Secretary shall take into consideration the delivery of such information in a manner that takes into account the range of communication needs of the intended recipients, including at-risk individuals. (f) Authorization of appropriations To carry out subsection (c), there are authorized to be appropriated $10,000,000 for each of fiscal years 2024 through 2028. 4. Education and dissemination of information on Long COVID (a) Long COVID public education program The Secretary shall develop and disseminate to the public regularly updated information regarding Long COVID, in plain language, including information on— (1) the awareness, incidence, and short- and long-term health effects associated with COVID–19 infection; (2) conditions related and often comorbid with Long COVID; (3) the availability, as medically appropriate, of treatment options for Long COVID and related conditions overlapping with Long COVID described in paragraph (2); and (4) strategies for reducing the likelihood of developing Long COVID. (b) Long COVID provider education program The Secretary, in consultation with representatives from impacted communities and health care providers who treat such communities or individuals, shall develop and disseminate to health care providers, including by developing or improving continuing medical education programs that advance the education of such providers, information on Long COVID, recommended assessment tools, and management of Long COVID and related conditions for the purpose of ensuring that health care providers remain informed about current information on Long COVID and related conditions. (c) Considerations In developing and disseminating information in subsections (a) and (b), the Secretary shall ensure that— (1) guidance on Long COVID diagnostics, treatments, and care include demographic factors to address health disparities; and (2) individuals with Long COVID and related conditions, and entities representing such individuals, are empowered to participate in protocol development and outreach and education strategies. (d) Dissemination of information The Secretary shall disseminate, in plain language, information under subsections (a) and (b), directly or through arrangements with intra-agency initiatives, nonprofit organizations, consumer groups, Federally qualified health centers, institutions of higher learning (as defined in section 101 of the Higher Education Act of 1965 ( 20 U.S.C. 1001 )), local educational agencies or State educational agencies (as defined in section 8101 of the Elementary and Secondary Education Act of 1965 ( 20 U.S.C. 7801 )), or Federal, State, Tribal, or local public private partnerships. 5. Definition In this Act, the term Long COVID means health conditions that may result, directly or indirectly, from COVID–19.