CARE for Long COVID Act

II 118TH CONGRESS 1ST SESSION S. 801 To address research on, and improve access to, supportive services for individuals with Long COVID. IN THE SENATE OF THE UNITED STATES MARCH 15, 2023 Mr. KAINE (for himself, Mr. MARKEY, Ms. DUCKWORTH, Mr. BLUMENTHAL, Ms. SMITH, Mr. PADILLA, Mr. WHITEHOUSE, Ms. STABENOW, Mr. REED, Ms. KLOBUCHAR, and Mr. KING) introduced the following bill; which was read twice and referred to the Committee on Health, Edu- cation, Labor, and Pensions A BILL To address research on, and improve access to, supportive services for individuals with Long COVID. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Comprehensive Access 4 to Resources and Education for Long COVID Act’’ or the 5 ‘‘CARE for Long COVID Act’’. 6 VerDate Sep 11 2014 23:18 Mar 25, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S801.IS S801 pbinns on DSKJLVW7X2PROD with $$_JOB 2 •S 801 IS SEC. 2. AUTHORIZATION TO FUND A PATIENT REGISTRY 1 FOR RESEARCH ON LONG COVID AND RE- 2 LATED CONDITIONS. 3 (a) IN GENERAL.—The Secretary of Health and 4 Human Services (referred to in this Act as the ‘‘Sec- 5 retary’’), acting in coordination with the Patient-Centered 6 Outcomes Research Institute established under section 7 1181 of the Social Security Act (42 U.S.C. 1320e(b)), 8 shall fund activities described in subsection (b) to improve 9 treatment and outcomes for individuals with Long COVID 10 and related conditions. 11 (b) ACTIVITIES DESCRIBED.—For purposes of sub- 12 section (a), activities described in this subsection shall in- 13 clude— 14 (1) creating or maintaining a regularly updated 15 patient registry of individuals with suspected or con- 16 firmed Long COVID and related conditions, includ- 17 ing information on— 18 (A) symptoms that arise while an indi- 19 vidual is initially infected with COVID–19 and 20 that may resolve over time or extend beyond the 21 resolution of the initial symptoms; 22 (B) persistent symptoms that arise after 23 an individual is initially infected with COVID– 24 19 and that the clinician of such individual has 25 VerDate Sep 11 2014 23:18 Mar 25, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S801.IS S801 pbinns on DSKJLVW7X2PROD with $$_JOB 3 •S 801 IS reason to suspect were related to the COVID– 1 19 diagnosis; 2 (C) symptoms that arise in an individual 3 that may be related to COVID–19, but a diag- 4 nosis of COVID–19 was not obtained and can- 5 not be identified due to a lack of antibodies, 6 false negative test results, or lack of access to 7 timely testing; 8 (D) treatments of individuals after primary 9 diagnosis of COVID–19 and the effectiveness of 10 such treatments; 11 (E) any other relevant questions or issues 12 related to individuals who experience a diag- 13 nosis of, treatment for, and management of 14 care with COVID–19, Long COVID, and re- 15 lated conditions; and 16 (F) comorbidities, vaccination status, and 17 demographics, including age, gender, race and 18 ethnicity, geographic location, disability, and oc- 19 cupation of registry participants; 20 (2) synthesis of information relating to individ- 21 uals experiencing Long COVID and related condi- 22 tions and other information available through the 23 patient registry; 24 VerDate Sep 11 2014 23:18 Mar 25, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S801.IS S801 pbinns on DSKJLVW7X2PROD with $$_JOB 4 •S 801 IS (3) dissemination of information to relevant 1 Federal departments and agencies and patients par- 2 ticipating in the registry to inform treatment and 3 policy related to COVID–19, Long COVID, and re- 4 lated conditions; 5 (4) an assurance that the registry utilizes com- 6 mon data elements and definitions for use in order 7 to promote appropriate data sharing for ongoing and 8 future research; and 9 (5) outreach to, and inclusion in the patient 10 registry, as appropriate, of individuals, including 11 children and older adults, from communities im- 12 pacted by high COVID–19 and Long COVID rates, 13 communities affected by health disparities and in- 14 equities (including Indian Tribes and Tribal organi- 15 zations, urban Indian organizations, and people with 16 disabilities), individuals with related conditions, 17 health care providers, first responders, military serv- 18 ice members, veterans, pregnant and lactating 19 women, frontline workers who may be impacted by 20 high COVID–19 and Long COVID rates, and health 21 care providers from diverse disciplines that may 22 treat individuals with COVID–19, Long COVID, 23 and related conditions. 24 VerDate Sep 11 2014 23:18 Mar 25, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S801.IS S801 pbinns on DSKJLVW7X2PROD with $$_JOB 5 •S 801 IS (c) VOLUNTARY PARTICIPATION; PRIVACY PROTEC- 1 TIONS.— 2 (1) VOLUNTARY PARTICIPATION.—Participation 3 in the registry described in subsection (b)(1) shall be 4 voluntary, and a person creating, assisting in the 5 creation of, or maintaining the registry shall not in- 6 clude in the registry information about an individual 7 unless the individual consents to the inclusion of 8 such information. 9 (2) PRIVACY PROTECTIONS.—Information about 10 an individual that is included in the registry shall be 11 subject to all applicable privacy protections under 12 Federal and State law. 13 (d) REPORT.—Not later than 1 year after the estab- 14 lishment of the synthesized patient registry under sub- 15 section (b)(2), and annually thereafter, the Secretary shall 16 submit a report that includes data, findings, and informa- 17 tion with respect to the status of the patient registry (in- 18 cluding progress, barriers, and issues) to Congress and the 19 President. 20 (e) AUTHORIZATION OF APPROPRIATIONS.—To carry 21 out this section, there is authorized to be appropriated 22 $30,000,000 for fiscal year 2024, which shall remain 23 available until expended. 24 VerDate Sep 11 2014 23:18 Mar 25, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S801.IS S801 pbinns on DSKJLVW7X2PROD with $$_JOB 6 •S 801 IS SEC. 3. RESEARCH ON UNITED STATES HEALTH CARE SYS- 1 TEM’S RESPONSE TO LONG COVID. 2 (a) IN GENERAL.—The Secretary, in coordination 3 with the Director of the Agency for Healthcare Research 4 and Quality, the Director of the National Institutes of 5 Health, and the Director of the Centers for Disease Con- 6 trol and Prevention, shall conduct or support research re- 7 lated to the United States health care system’s response 8 to Long COVID, including with respect to— 9 (1) the expansion and effectiveness of post-in- 10 fectious disease treatment, including— 11 (A) identifying barriers to access for treat- 12 ment of COVID–19, Long COVID, and related 13 conditions for veterans, older adults, people 14 with disabilities, children and young adults, 15 communities of color, underserved and rural 16 communities, and other groups impacted by 17 high rates of COVID–19, as determined by the 18 Secretary; 19 (B) evaluating and identifying potential 20 gaps or other weaknesses that contribute to 21 age, gender, geographic location, disability, oc- 22 cupation, and racial and ethnic disparities with 23 respect to COVID–19 infection rates, severity 24 and length of symptoms, associated diagnoses, 25 and outcomes; and 26 VerDate Sep 11 2014 23:18 Mar 25, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S801.IS S801 pbinns on DSKJLVW7X2PROD with $$_JOB 7 •S 801 IS (C) identifying trends associated with dif- 1 ferences in diagnosis and treatment of Long 2 COVID and related conditions by demographic 3 factors such as age, gender, geographic loca- 4 tion, disability, occupation, race, ethnicity, or 5 other factors identified by the Secretary to pro- 6 mote health equity; and 7 (2) conducting and supporting research to— 8 (A) identify health care strategies that 9 help mitigate age, gender, geographic location, 10 disability, occupation, and racial and ethnic dis- 11 parities in COVID–19 infection rates, hos- 12 pitalizations, severity and length of symptoms, 13 secondary illnesses, and outcomes; 14 (B) identify health care-related factors 15 contributing to such disparities in COVID–19 16 infection rates, hospitalizations, severity and 17 length of symptoms, secondary illnesses, and 18 outcomes; and 19 (C) provide recommendations on ensuring 20 equity in diagnosis and access to quality post- 21 infectious treatments that may be advanced to 22 mitigate such disparities. 23 (b) AUTHORIZATION OF APPROPRIATIONS.—To carry 24 out this section, there is authorized to be appropriated 25 VerDate Sep 11 2014 23:18 Mar 25, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S801.IS S801 pbinns on DSKJLVW7X2PROD with $$_JOB 8 •S 801 IS $15,000,000 for fiscal year 2024, which shall remain 1 available until expended. 2 SEC. 4. EDUCATION AND DISSEMINATION OF INFORMATION 3 ON LONG COVID. 4 (a) LONG COVID PUBLIC EDUCATION PROGRAM.— 5 The Secretary shall develop and disseminate to the public 6 regularly updated information regarding Long COVID, in 7 plain language and in a manner that is culturally and lin- 8 guistically appropriate and easily accessible to people with 9 disabilities and people with limited English proficiency, in- 10 cluding information on— 11 (1) the awareness, incidence, and short- and 12 long-term health effects associated with COVID–19 13 infection, including Long COVID associated dis- 14 ability; 15 (2) illnesses related and often comorbid with 16 Long COVID, which may include— 17 (A) myalgic encephalomyelitis/chronic fa- 18 tigue syndrome; 19 (B) fibromyalgia; 20 (C) postural orthostatic tachycardia syn- 21 drome and other forms of dysautonomia; 22 (D) autoimmune diseases associated with 23 viral triggers; 24 VerDate Sep 11 2014 23:18 Mar 25, 2023 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S801.IS S801 pbinns on DSKJLVW7X2PROD with $$_JOB 9 •S 801 IS (E) connective tissue diseases exacerbated 1 or triggered by infections; 2 (F) mast cell activation syndrome; 3 (G) related conditions and illnesses that 4 may affect adults, young adults, or children; 5 and 6 (H) other conditions, as the Secretary de- 7 termines appropriate; 8 (3) the availability, as medically appropriate, of 9 treatment options for Long COVID and related con- 10 ditions overlapping with Long COVID identified 11 under paragraph (2); and 12 (4) strategies for reducing the likelihood of de- 13 veloping Long COVID. 14 (b) LONG COVID PROVIDER EDUCATION PRO- 15 GRAM.—The Secretary, in consultation with representa- 16 tives from impacted communities and health care pro- 17 viders who treat such communities or individuals, shall de- 18 velop and disseminate to health care providers, including 19 by developing or improving continuing medical education 20 programs that advance the education of such providers, 21 information on Long COVID, recommended assessment 22 tools, including how to assess patients’ functional capacity 23 to support applications for disability benefits, and man- 24 agement of Long COVID and related conditions for the 25 VerDate Sep 11 2014 23:18 Mar 25, 2023 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S801.IS S801 pbinns on DSKJLVW7X2PROD with $$_JOB 10 •S 801 IS purpose of ensuring that health care providers remain in- 1 formed about current information on Long COVID and 2 related conditions, including information on— 3 (1) Long COVID symptoms such as cognitive, 4 neurological, psychiatric, gastrointestinal, res- 5 piratory, and cardiovascular symptoms; 6 (2) myalgic encephalomyelitis/chronic fatigue 7 syndrome and fibromyalgia; 8 (3) postural orthostatic tachycardia syndrome 9 and other forms of dysautonomia; 10 (4) autoimmune diseases associated with viral 11 triggers; 12 (5) connective tissue diseases exacerbated or 13 triggered by infections; 14 (6) mast cell activation syndrome; 15 (7) related conditions and illnesses that may af- 16 fect adults, young adults, or children; and 17 (8) other conditions as the Secretary deter- 18 mines appropriate. 19 (c) CONSIDERATIONS.—In developing and dissemi- 20 nating information in subsections (a) and (b), the Sec- 21 retary shall ensure that— 22 (1) guidance on Long COVID diagnostics, 23 treatments, and care include demographic factors 24 such as age, gender, geographic location, disability, 25 VerDate Sep 11 2014 23:18 Mar 25, 2023 Jkt 039200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S801.IS S801 pbinns on DSKJLVW7X2PROD with $$_JOB 11 •S 801 IS occupation, race and ethnicity, and other factors 1 identified by the Secretary to promote health equity; 2 and 3 (2) individuals with Long COVID and related 4 conditions, and entities representing such individ- 5 uals, are empowered to participate in protocol devel- 6 opment and outreach and education strategies. 7 (d) DISSEMINATION OF INFORMATION.—The Sec- 8 retary shall disseminate, in plain language and in a man- 9 ner that is culturally and linguistically appropriate and 10 easily accessible to people with disabilities and individuals 11 with limited English proficiency, information under sub- 12 sections (a) and (b), directly or through arrangements 13 with intra-agency initiatives, nonprofit organizations, con- 14 sumer groups, Federally qualified health centers, institu- 15 tions of higher learning (as defined in section 101 of the 16 Higher Education Act of 1965 (20 U.S.C. 1001)), local 17 educational agencies or State educational agencies (as de- 18 fined in section 8101 of the Elementary and Secondary 19 Education Act of 1965 (20 U.S.C. 7801)), or Federal, 20 State, Tribal, or local public private partnerships. 21 (e) AUTHORIZATION OF APPROPRIATIONS.—To carry 22 out this section, there is authorized to be appropriated 23 $30,000,000 for each of fiscal years 2024 through 2026, 24 which shall remain available until expended. 25 VerDate Sep 11 2014 23:18 Mar 25, 2023 Jkt 039200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S801.IS S801 pbinns on DSKJLVW7X2PROD with $$_JOB 12 •S 801 IS SEC. 5. INTERAGENCY COORDINATION AND INFORMATION 1 DISSEMINATION ON RIGHTS ASSOCIATED 2 WITH LONG COVID. 3 (a) IN GENERAL.—The Secretary shall convene rel- 4 evant agencies to develop information and resources to 5 make available to the public and for dissemination to indi- 6 viduals and communities impacted by Long COVID and 7 related conditions to raise awareness and provide edu- 8 cation on the impact Long COVID and related conditions 9 may have on rights associated with employment, disability 10 status, and education afforded under Federal and State 11 law. 12 (b) COLLABORATION AND CONSULTATION.—In devel- 13 oping the informatio [Text truncated for display. Full text available on Congress.gov.]