National Lyme and Tick-Borne Diseases Control and Accountability Act of 2019

I 116TH CONGRESS 1ST SESSION H. R. 220 To provide for a national strategy to address and overcome Lyme disease and other tick-borne diseases, and for other purposes. IN THE HOUSE OF REPRESENTATIVES JANUARY 3, 2019 Mr. SMITH of New Jersey (for himself, Mr. PETERSON, Mr. POSEY, Ms. STEFANIK, Mr. FITZPATRICK, Mr. SIRES, Ms. PINGREE, and Mrs. HARTZLER) introduced the following bill; which was referred to the Com- mittee on Energy and Commerce A BILL To provide for a national strategy to address and overcome Lyme disease and other tick-borne diseases, and for other purposes. 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 ‘‘National Lyme and 4 Tick-Borne Diseases Control and Accountability Act of 5 2019’’. 6 VerDate Sep 11 2014 23:10 Jan 16, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H220.IH H220 pbinns on DSK79D2C42PROD with BILLS 2 •HR 220 IH SEC. 2. OFFICE OF OVERSIGHT AND COORDINATION FOR 1 TICK-BORNE DISEASES. 2 (a) ESTABLISHMENT.—The Secretary of Health and 3 Human Services shall establish in the Office of the Sec- 4 retary the Office of Oversight and Coordination for Tick- 5 Borne Diseases, to be headed by a director appointed by 6 the Secretary— 7 (1) to oversee the creation and updating of an 8 integrated national strategy to overcome Lyme dis- 9 ease and other tick-borne diseases; and 10 (2) to oversee and coordinate Lyme disease and 11 other tick-borne disease programs and activities 12 across the agencies and offices of the Department of 13 Health and Human Services. 14 (b) OBJECTIVE OF OFFICE.—In carrying out sub- 15 section (a), the Director of the Office shall facilitate and 16 work to ensure accomplishment of the following activities: 17 (1) Expansion and enhancement of epidemiolog- 18 ical research and basic, translational, and clinical bi- 19 ological and biomedical research. 20 (2) Expansion and improvement of the surveil- 21 lance and reporting of Lyme disease and other tick- 22 borne disease, including coinfections with agents of 23 more than one tick-borne disease. 24 (3) Development of effective diagnostic tests to 25 accurately and timely diagnose Lyme disease and 26 VerDate Sep 11 2014 23:10 Jan 16, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H220.IH H220 pbinns on DSK79D2C42PROD with BILLS 3 •HR 220 IH other tick-borne disease, including direct detention 1 tests. 2 (4) Development of treatments to cure or im- 3 prove the lives of those who are infected with Lyme 4 disease or other tick-borne disease or who suffer 5 from a tick-induced disorder. 6 (5) Design and conduct of clinical trials of suf- 7 ficient size and duration to support clinical rec- 8 ommendations. 9 (6) Development and maintenance of one or 10 more registries of patients and their experiences re- 11 lating to exposure to, diagnosis for, and treatment 12 of tick-borne disease, including outcomes, which reg- 13 istries shall protect the confidentiality and safety of 14 patient data. 15 (7) Systematic documentation of the experi- 16 ences of health care professionals in diagnosing and 17 treating tick-borne disease, including diagnostic and 18 treatment outcomes. 19 (8) Inclusion of individuals with chronic Lyme 20 disease in clinical, research, and service efforts. 21 (9) Coordination with international bodies to in- 22 tegrate and inform the fight against Lyme disease 23 and tick-borne disease globally. 24 VerDate Sep 11 2014 23:10 Jan 16, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H220.IH H220 pbinns on DSK79D2C42PROD with BILLS 4 •HR 220 IH (c) INTEGRATION OF TICK-BORNE DISEASE WORK- 1 ING GROUP FINDINGS AND RECOMMENDATIONS.—In car- 2 rying out this section, the Director of the Office shall, as 3 directed by the Secretary, with any modifications made by 4 and as otherwise determined appropriate by the Secretary, 5 oversee and coordinate integration and implementation, 6 into the activities of the Office and the activities and pro- 7 grams of the agencies and offices of the Department of 8 Health and Human Services, of the recommendations to 9 the Secretary and the findings and conclusions in the lat- 10 est report of the Tick-Borne Disease Working Group sub- 11 mitted to the Secretary and congressional committees. 12 (d) PRIORITY BASED ON DISEASE BURDEN.—In car- 13 rying out this section, the Director of the Office shall give 14 priority to Lyme disease and other tick-borne disease 15 based on assessments of disease burden in the United 16 States. 17 SEC. 3. NATIONAL STRATEGY. 18 (a) IN GENERAL.—The Secretary, in coordination 19 with the Director of the Office, and in consultation with 20 the Tick-Borne Disease Working Group, the agencies and 21 offices of the Department of Health and Human Services, 22 and other Federal agencies outside of the Department of 23 Health and Human Services as appropriate, shall— 24 VerDate Sep 11 2014 23:10 Jan 16, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H220.IH H220 pbinns on DSK79D2C42PROD with BILLS 5 •HR 220 IH (1) not later than 2 years after the date of en- 1 actment of this Act, develop and submit to the Con- 2 gress a national strategy for the conduct and sup- 3 port of Lyme disease and other tick-borne disease or 4 disorder programs and activities; and 5 (2) not less than every 2 years thereafter, up- 6 date such strategy. 7 (b) CONTENTS.—The strategy under subsection (a) 8 shall include— 9 (1) proposed budgetary requirements; 10 (2) an assessment of all federally funded pro- 11 grams and activities related to surveillance, diag- 12 nosis, treatment, education, or prevention with re- 13 spect to Lyme disease or other tick-borne disease, an 14 evaluation of progress and performance based on 15 mission and purpose, and a description of significant 16 challenges or barriers to performance, including an 17 assessment of Federal grants awarded; 18 (3) a strategy for improving diagnosis, treat- 19 ment, and prevention, including increasing the im- 20 pact of grants awarded by the National Institutes of 21 Health, the Centers for Disease Control and Preven- 22 tion, and other agencies and offices of the Depart- 23 ment of Health and Human Services; 24 VerDate Sep 11 2014 23:10 Jan 16, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H220.IH H220 pbinns on DSK79D2C42PROD with BILLS 6 •HR 220 IH (4) a strategy for improving outcomes of indi- 1 viduals with Lyme disease or another tick-borne dis- 2 ease or disorder, including progress related to chron- 3 ic or persistent symptoms and chronic or persistent 4 infection and coinfections, including plans for evalu- 5 ating the potential value of and supporting the con- 6 duct of observational studies, comparative effective- 7 ness research, patient-centered outcomes research, 8 or other real world evidence; 9 (5) the appropriate benchmarks to measure 10 progress in achieving the improvements described in 11 paragraphs (3) and (4); 12 (6) a strategy for improving interactions, co- 13 ordination, and partnerships with other Federal 14 agencies, State and local governments, and global 15 entities; and 16 (7) the latest recommendations of the Tick- 17 Borne Disease Working Group and the steps taken 18 by the agencies and offices of the Department of 19 Health and Human Services to implement those rec- 20 ommendations. 21 VerDate Sep 11 2014 23:10 Jan 16, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H220.IH H220 pbinns on DSK79D2C42PROD with BILLS 7 •HR 220 IH SEC. 4. FEDERAL ACTIVITIES RELATED TO THE DIAGNOSIS, 1 SURVEILLANCE, AND PREVENTION OF, AND 2 RESEARCH ON, LYME DISEASE AND OTHER 3 TICK-BORNE DISEASES AND DISORDERS. 4 (a) IN GENERAL.—The Secretary, in coordination 5 with the Director of the Office, acting as the Secretary 6 determines appropriate through the Director of the Cen- 7 ters for Disease Control and Prevention, the Director of 8 the National Institutes of Health, the Commissioner of 9 Food and Drugs, the Director of the Agency for 10 Healthcare Research and Quality, the Administrator of 11 the Health Resources and Services Administration, the Di- 12 rector of the Indian Health Service, and the heads of other 13 Federal agencies, and in consultation with the Tick-Borne 14 Disease Working Group, shall provide for— 15 (1) the conduct or support of the activities de- 16 scribed in paragraphs (1) through (8) of subsection 17 (b); and 18 (2) the coordination of all programs and activi- 19 ties of the Department of Health and Human Serv- 20 ices related to Lyme disease and other tick-borne 21 diseases and disorders and Bartonella. 22 (b) ACTIVITIES.—The activities to be conducted or 23 supported under subsection (a)(1) consist of the following: 24 (1) EXPANSION AND ENHANCEMENT OF RE- 25 SEARCH.— 26 VerDate Sep 11 2014 23:10 Jan 16, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H220.IH H220 pbinns on DSK79D2C42PROD with BILLS 8 •HR 220 IH (A) IN GENERAL.—The Secretary shall ex- 1 pand and intensify epidemiological, basic, 2 translational, and clinical research regarding 3 Lyme disease and other tick-borne disease and 4 disorders and bartonellosis to better under- 5 stand— 6 (i) the pathophysiology of Borrelia 7 burgdorferi and other tick-borne micro- 8 organisms that are human pathogens and 9 of Bartonella; 10 (ii) pathophysiological changes over 11 time, including pathogen persistence pro- 12 files for patients with differing treatment 13 histories; 14 (iii) activation and deactivation of im- 15 mune system processes; and 16 (iv) whether, and what species of, 17 Bartonella are transmitted by ticks. 18 (B) CLINICAL OUTCOMES RESEARCH.—The 19 Secretary shall conduct or support clinical out- 20 comes research to— 21 (i) establish epidemiological research 22 objectives to determine the long-term 23 course of illness for Lyme disease and 24 other tick-borne diseases and disorders; 25 VerDate Sep 11 2014 23:10 Jan 16, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H220.IH H220 pbinns on DSK79D2C42PROD with BILLS 9 •HR 220 IH (ii) establish patient-centered treat- 1 ment outcome objectives to allow for the 2 comparative effectiveness of different treat- 3 ment modalities; and 4 (iii) establish patient-centered re- 5 search objectives to help elucidate prom- 6 ising treatment protocols for individuals 7 suspected of harboring coinfections with 8 more than one tick-transmitted pathogen. 9 (C) COLLABORATIVE, MULTIDISCIPLINARY 10 RESEARCH.—The Secretary shall encourage the 11 solicitation of proposals for collaborative, multi- 12 disciplinary research that would— 13 (i) result in innovative approaches to 14 study emerging scientific opportunities or 15 eliminate gaps in research to improve the 16 research portfolio, including application of 17 successful and promising advances in the 18 study of other types of diseases, such as 19 upregulating or downregulating immune 20 system cells or processes; 21 (ii) outline key research questions, 22 methodologies, and knowledge gaps; 23 (iii) expand the number of research 24 proposals that involve collaboration be- 25 VerDate Sep 11 2014 23:10 Jan 16, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H220.IH H220 pbinns on DSK79D2C42PROD with BILLS 10 •HR 220 IH tween 2 or more national research insti- 1 tutes or national centers of the National 2 Institutes of Health, including proposals 3 for research through the Common Fund 4 pursuant to section 402(b)(7) of the Public 5 Health Service Act (42 U.S.C. 282(b)(7)) 6 to improve the research portfolio; 7 (iv) expand the number of collabo- 8 rative multi-institutional research grants 9 related to tick-borne disease; and 10 (v) involve additional national re- 11 search institutes and national centers of 12 the National Institutes of Health in intra- 13 mural and extramural research on tick- 14 borne disease, such as the National Insti- 15 tute of Neurological Disorders and Stroke 16 conducting or sponsoring research on 17 neurologic Lyme disease. 18 (D) EVALUATION.—Not later than 2 years 19 after the date of enactment of this Act, the Sec- 20 retary shall evaluate and make findings on— 21 (i) the feasibility and potential value 22 to the research community of establishing 23 a deidentified human subjects database for 24 VerDate Sep 11 2014 23:10 Jan 16, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H220.IH H220 pbinns on DSK79D2C42PROD with BILLS 11 •HR 220 IH Lyme disease and other tick-borne diseases 1 and disorders; 2 (ii) existing government or private 3 biorepositories for Lyme disease and other 4 tick-borne diseases and disorders and 5 whether— 6 (I) specimens and samples are 7 adequate and available to meet re- 8 searcher needs; or 9 (II) there are problems or chal- 10 lenges for researcher acquisition of 11 samples and specimens; and 12 (iii) the scope and use of specimens 13 and samples from cadavers, the questions 14 and answers such research may provide, 15 and the need for additional support of re- 16 searchers using cadaver specimens. 17 (E) PRIORITY.—In carrying out this para- 18 graph, the Secretary shall make it a priority to 19 determine the extent of posttreatment persist- 20 ence of Borrelia burgdorferi and the clinical sig- 21 nificance of such persistence. 22 (2) DEVELOPMENT OF NEW AND IMPROVED DI- 23 AGNOSTIC TESTS.— 24 VerDate Sep 11 2014 23:10 Jan 16, 2019 Jkt 089200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H220.IH H220 pbinns on DSK79D2C42PROD with BILLS 12 •HR 220 IH (A) IN GENERAL.—The Secretary, in co- 1 operation with the Director of the Office, and 2 acting through the Directors of the Centers for 3 Disease Control and Prevention and the Direc- 4 tor of the National Institutes of Health, shall 5 conduct and support research to— 6 (i) provide for the timely evaluation of 7 promising new and improved diagnostic 8 methods, including direct-detection tests, 9 antibody-based tests, and tests based on 10 biosignature and biomarker profiles to 11 make a specific diagnosis or aid in dif- 12 ferential diagnoses; 13 (ii) improve the sensitivity of Lyme 14 disease tests at all stages of disease pro- 15 gression; 16 (iii) develop a Lyme disease test capa- 17 ble of distinguishing between past and ac- 18 tive infections; 19 (iv) improve timely, sensitive, and spe- 20 cific diagnostic tools and tests for Rocky 21 Mountain spotted fever; and 22 (v) improve the performance (timeli- 23 ness and accuracy) of tools and tests for 24 VerDate Sep 11 2014 23:10 Jan 16, 2019 Jkt 089200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H220.IH H220 pbinns on DSK79D2C42PROD with BILLS 13 •HR 220 IH other tick-borne diseases found in [Text truncated for display. 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