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                              TBDWG March 3-4, 2020 - Meeting Summary - Day 1


    

    

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TBDWG March 3-4, 2020 - Meeting Summary - Day 1








  
  
    

  
      





*Note: For context and clarity, speaker credentials will be included upon first mention in each meeting’s summary. Subsequently, individuals will be referenced by their first names to equalize expertise across the many diverse disciplines represented in this document. All perspectives and expertise, including patient-lived experience, is valued equally. Speaking on a first-name basis helps the Tick-Borne Disease Working Group ensure that all voices are heard and valued based on merit and without the bias of titles, eminence, or prestige.*
Welcome and Roll Call
James (Jim) Berger, MS, MT (ASCP), SBB, Senior Blood and Tissue Policy Advisor, Office of Infectious Disease and HIV/AIDS Policy (OIDP), Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services (HHS); Designated Federal Officer (DFO) for the Tick-Borne Disease Working Group, called the meeting to order and conducted roll call (see Appendix 1 and Appendix 2: Tick-Borne Disease Working Group Members and HHS Support Staff). Working Group members announced their names, the organizations they represent, and the subcommittees they co-chair. The meeting started with a quorum.
Welcome Remarks
Jim introduced Tammy R. Beckham, PhD, Director, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, HHS, who welcomed all meeting participants and thanked them for their dedication to this project. She highlighted the increasing rate of tick-borne disease transmission in the United States, specifically in Pennsylvania and New Jersey. She encouraged the Working Group members, as they write their report, to formulate recommendations that will ensure clear, actionable impact, citing Congress’s swift and decisive response to the recommendations in the Working Group’s 2018 Report to Congress. Dr. Beckham highlighted that the Kay Hagan Tick Act of 2019 stemmed from the Working Group’s efforts and that her office would be overseeing the development of the resulting vector-borne disease strategy, about which the Tick-Borne Disease Working Group will be consulted.
Co-Chair Welcome, Recap of Meeting 11, Agenda for Today
David Hughes Walker, MD, Professor, Department of Pathology, the Carmage and Martha Walls Distinguished University Chair in Tropical Diseases; Executive Director, UTMB Center for Biodefense and Emerging Infectious Diseases; Working Group Co-Chair, thanked Dr. Beckham and stated that he was hopeful that the Working Group would be able to meet their expectations.
Leigh Ann Soltysiak, MS, Owner, Principal, Silverleaf Consulting, LLC; Adjunct Professor, Stevens Institute of Technology, Entrepreneurship Thinking; Working Group Co-Chair, welcomed everyone to Philadelphia. She described her struggles as a patient with Lyme disease and multiple coinfections, and then explained how this experience led her to seek membership on the Tick-Borne Disease Working Group as a way to help other patients with tick-borne diseases and conditions. She praised the members’ dedication, passion, and wide-ranging expertise and encouraged them to build on the efforts of the 2018 Working Group.
Leigh Ann briefly reviewed what took place at Meeting 11, stating that the primary focus was to hear public comments and allow the subcommittee co-chairs to present their reports and potential actions to the Tick-Borne Disease Working Group. She then outlined today’s meeting agenda, including an overview of the Working Group’s Mission and Vision Statements and Values; discussions of the template and draft outline for the Report to Congress; an update on  current tick surveillance activities of the Centers for Disease Control and Prevention (CDC); and discussion of the top recommendations from six subcommittees. (Note: The meeting ultimately ran long, and two of the subcommittee discussions were moved to Day 2. Due to time constraints, the updates originally scheduled for Day 2 from the Federal Inventory and Public Comment Subcommittees were canceled.)
Overview of the Working Group’s Mission Statement, Vision Statement, and Values
Jim reviewed the Working Group’s Mission Statement, as follows:
The Tick-Borne Disease Working Group’s mission, as mandated through the *21st Century Cures Act*, is to provide expertise and to review all efforts within the Department of Health and Human Services related to all tick-borne diseases, to help ensure inter-agency coordination and minimize overlap, and to examine research priorities. As part of this mandate, and in order to provide expertise, we will ensure that the membership of the Working Group represents a diversity of scientific disciplines and views and is comprised of both Federal and non-Federal representatives, including patients, family members or caregivers, advocates of non-profit organizations in the interest of the patient with tick-borne illness, scientists, and researchers. A major responsibility of our mission will be to develop and regularly update the action of HHS from the past, present, and the future.
Jim then reviewed the Working Group’s Vision Statement, as follows:
**SHARED VISION:**A nation free of tick-borne diseases where new infections are prevented and patients have access to affordable care that restores health.
Finally, Jim gave an overview of the Working Group’s Core Values, the complete versions of which are provided below.
**RESPECT: Everyone is valued**
	We respect all people, treating them and their diverse experiences and perspectives with dignity, courtesy, and openness, and ask only that those we encounter in this mission return the same favor to us. Differing viewpoints are encouraged, always, with the underlying assumption that inclusivity and diversity of minority views will only strengthen and improve the quality of our collective efforts in the long term.
**INNOVATION: Shifting the paradigm, finding a better way**
	We strive to have an open mind and think out of the box. We keep what works and change what doesn’t. We will transform outdated paradigms when necessary, in order to improve the health and quality of life of every American.
**HONESTY and INTEGRITY: Find the truth, tell the truth**
	We are honest, civil, and ethical in our conduct, speech, and interactions with our colleagues and collaborators. We expect our people to be humble, but not reticent, and to question the status quo whenever the data and the evidence support such questions, to not manipulate facts and data to a particular end or agenda, and to acknowledge and speak the truth where we find it.
**EXCELLENCE: Quality, real-world evidence underlies decision-making**
	We seek out rigorous, evidence-based, data-driven, and human-centered insights and innovations—including physician and patient experiences—that we believe are essential for scientific and medical breakthroughs. We foster an environment of excellence that strives to achieve the highest ethical and professional standards, and which values the development of everyone’s skills, knowledge, and experience.
**COMPASSION: Finding solutions to relieve suffering**
	We listen carefully with compassion and an open heart in order to find solutions which relieve the suffering of others. We promise to work tirelessly to serve the greater good until that goal is achieved.
**COLLABORATION:** **Work with citizens and patients as partners**
	The best results and outcomes won’t be created behind closed doors, but will be co-created in the open with input of the American public working together with these core values as our guide. We actively listen to the patient experiences shared with us, respect the lived experiences of patients and their advocates, and learn from their experiences in our pursuit of objective truth. Across diverse audiences, we communicate effectively and collaborate extensively to identify shared goals and leverage resources for maximum public health impact.
**ACCOUNTABILITY: The buck stops here**
	We, as diligent stewards of the public trust and the funds provided by our fellow citizens, pledge to be transparent in all of our proceedings and to honor our commitments to ourselves and others, while taking full responsibility for our actions in service to American people.
Working Group Objectives, Timeline, and Meeting 12 Goals
Leigh Ann then outlined the Working Group’s charge, as follows:
No later than two years after the date of enactment of the authorizing legislation, develop or update a summary of
		Ongoing tick-borne disease research, including research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, duration of illness, and intervention for individuals with tick-borne diseases;
			Advances made pursuant to such research;
			Federal activities related to tick-borne diseases, including
				Epidemiological activities related to tick-borne diseases; and
					Basic, clinical, and translational tick-borne disease research related to the pathogenesis, prevention, diagnosis, and treatment of tick-borne disease.
			Gaps in tick-borne disease research described 3b;
			The Working Group’s meeting; and
			The comments received by the Working Group.
	Make recommendations to the Secretary regarding any appropriate changes or improvements to such activities and research; and
	Solicit input from States, localities, and non-governmental entities, including organizations representing patients, health care providers, researchers, and industry regarding scientific advances, research questions, surveillance activities, and emerging strains and species of pathogenic organisms.David stated that the purpose of today’s meeting is to finalize the template, outline, and recommendations for the 2020 Tick-Borne Disease Working Group Report to Congress and the HHS Secretary and determine writing co-leads.
Leigh Ann outlined the timeline for completing the Report to Congress and noted that specific deliverables will be discussed during Day 2 of the meeting.
Overview of the Report: Requirements and Rules
As a reminder of the Working Group’s responsibilities, Jim reviewed the following language from Section 2062, paragraph 2, in the *21st Century Cures Act*.
The Working Group shall:
Not later than 2 years after the date of enactment of this Act, develop or update a summary of ongoing tick-borne disease research, including.
		Research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, duration of illness, and intervention for individuals with tick-borne diseases;.
			Advances made pursuant to such research;.
			Federal activities related to tick-borne diseases, including—
				epidemiological activities related to tick- borne diseases; and
					basic, clinical, and translational tick-borne disease research related to the pathogenesis, prevention, diagnosis, and treatment of tick-borne diseases
			Gaps in tick-borne disease research described in clause (3)(II);
			The Working Group’s meetings required under paragraph 4; and
			The comments received by the Working Group;
	Make recommendations to the Secretary regarding any appropriate changes or improvements to such activities and research; and
	Solicit input from states, localities, and non-governmental entities, including organizations representing patients, health care providers, researchers, and industry regarding scientific advances, research questions, surveillance activities, and emerging strains in species of pathogenic organisms.Jim explained that the Working Group will submit its 2020 report to the HHS Secretary; the Committee on Energy and Commerce of the House of Representatives; and the Committee on Health, Education, Labor, and Pensions of the Senate. He noted that the report will be publicly available on the HHS website for the Tick-Borne Disease Working Group.
David then transitioned the meeting to discussions of the template and outline for the 2020 Report to Congress and the HHS Secretary.
Report to Congress Template
Jennifer Gillissen, Contractor, Kauffman and Associates, Inc., provided an overview of the proposed template for the 2020 Report to Congress, noting that it was modeled after the well-received 2018 Report. She itemized the features that will remain unchanged from the previous report—including color scheme, branding, and formatting—and highlighted the items that will be subject to change as the Working Group compiles its report, such as the symbols at the start of each chapter, images, graphics, tables, and front-cover graphics.
Members suggested the following revisions to the template:
Add a feature on the front cover of this report to differentiate it from the 2018 report.
	Change the overall color scheme to a lighter green.
	Swap out the images, so they are relevant to topics covered in the 2020 report.Jennifer commented that the Working Group can decide on the images during the coming months.
Vote on Report to Congress Template
Thirteen Working Group members voted yes to accept the template for the 2020 Report to Congress with the understanding that certain features were subject to change as decided by the Working Group. One member was absent.
Report to Congress Outline
David and Leigh Ann presented the draft outline of the 2020 Report to Congress and asked for comment. David noted that revisions can be made to the outline once the recommendations have been determined by the Working Group. Patricia V. Smith, President, Lyme Disease Association, Inc., asked if the recommendations will be voted on individually or as a whole at the end of the process. Leigh Ann clarified that members will vote on each recommendation, then on all of them at the end of the process. Jim further clarified that if changes are made to previously voted-upon recommendations, the Working Group will re-vote on the revised language.
At this point, the Working Group agreed to proceed with the day’s agenda and discuss the outline at the end of Day 2, at which time they would vote.
CDC Tick Surveillance Update
Ben Beard, Deputy Director, Division of Vector-Borne Diseases, CDC; Associate Editor, Emerging Infectious Diseases, provided an update on CDC tick surveillance efforts. He explained that, in response to one of the recommendations in the 2018 Tick-Borne Disease Working Group Report to Congress, CDC has begun implementing an active tick surveillance system to better define indicators of where the public is exposed to ticks and tick-borne pathogens. He elaborated that, while the system is still in its infancy, its purpose is twofold:
Provide actionable, evidence-based information to clinicians, the public, and policy makers about changing tick and pathogen distribution by identifying which pathogens are present in which ticks, and by tracking new tick species and pathogens.
	Explain and predict epidemiology trends, for example, range expansion of the northern clade of blacklegged (*I. scapularis*) ticks into southern states.Ben explained that CDC has posted on its website, and distributed to state health departments, guidance on best practices for conducting tick surveillance, addressing safety concerns, and implementing protocols for pathogen testing and species identification. He commented that, as of 2020, CDC supports 25 state and territorial health departments and collects ticks for testing from 10 different jurisdictions. Ben added that states use CDC’s ArboNET surveillance system to submit data, which is then used to create incidence maps at the county level.
When asked about the scope of this initiative, Ben responded that the system is nationwide, and states receive funds from CDC to apply toward vector-borne diseases in the following three areas: 1) diagnostic and laboratory capacity; 2) surveillance; 3) and prevention and control. He explained that the states can decide how best to allocate the funding they receive. He reiterated that the system is still in development and will continue to be expanded as more funds are allocated to CDC for the program.
The group also discussed the following topics.
Types of information shared with the U.S. Department of Defense (DoD)
	Whether or not this can be used to track clinical surveillance data
	Relevant discussions that took place at CDC’s Vector Week 2020
	Standardization and validation of data
	*Bartonella*as a common coinfectionDiscussion of the Process for Voting on Recommendations
As the group began to look at recommendations, several questions came up about process. One member pointed out that some recommendations have sub-bullets while others do not. Another member commented that many of the recommendations will overlap. A third member asked whether the Working Group would be voting on each individual recommendation or on all recommendations once they had all been reviewed and discussed.
The group generally agreed that, once all of the recommendations had been presented, redundancies could be addressed; overarching themes could be identified; and the recommendations could be revised and/or consolidated and voted on again.
Vote on the Process for Voting on Recommendations
The Working Group voted on the motion to vote on each subcommittee’s recommendations as they are presented, with the understanding that the group will be able to revisit and revise them later in the meeting. All members in attendance (13) voted yes to accept the motion. One member was absent.
Discussion of Recommendation Style
The group discussed how specific and prescriptive the recommendations should be in order to ensure that they would be effective and well-received by the report audience. One member pointed out that the more prescriptive a recommendation is, the more difficult it can be to implement. The overall consensus was that the recommendations should be relatively broad but concise, with the detailed information included in the body of the chapter.
Vote on Recommendation Style
Leigh Ann asked the Working Group to vote on the motion to consolidate each potential action to a concise top-line statement. The Working Group members in attendance (12) voted yes to accept the motion. Two members were absent.
Discussion of the Proposed Recommendations from the Rickettsiosis Subcommittee
Rickettsiosis Subcommittee Co-Chairs David Walker and CDR Todd Myers, PhD, HCLD (ABB), MB (ASCP), Office of Counterterrorism and Emerging Threats, Office of the Chief Scientist, Office of the Commissioner, U.S. Food and Drug Administration (FDA), HHS, presented the following proposed recommendations to the Working Group.
Proposed Recommendation 1
Establish and fund a research program to develop sensitive and specific diagnostic tests as local laboratory assays and leading to point-of-care tests that improve the availability of and access to species-specific assays for acute Rocky Mountain spotted fever and *Rickettsia parkeri*rickettsiosis, and for human monocytic ehrlichiosis and human granulocytic anaplasmosis; and establish serologic assays that distinguish between antibodies to *Rickettsia rickettsii*, *R. parkeri*, *Rickettsia* 364D, and *R. amblyommatis,* and between *Ehrlichia chaffeensis*, *Ehrlichia ewingii,* and *Anaplasma phagocytophilum*. Encourage development of these tests as *in vitro* diagnostics approved by FDA.
Discussion of Recommendation 1
A couple members questioned whether or not Recommendation 1 would be effective in advancing diagnosis of rickettsial, anaplasmal, and ehrlichial diseases, noting that existing tests could be improved and there was no guarantee that new tests would be reliable. In support of Recommendation 1, David explained that these three diseases are different from the other tick-borne diseases in that they are acute and life-threatening, requiring an early diagnosis. He added that, clinically, they cannot be distinguished one from the other during the early stage of illness. He stressed, therefore, the importance of improved diagnostics, specifically those that are species-specific and applicable to both acute and convalescent disease.
Working Group members discussed the implications of FDA approval, and a member clarified that the recommendation does not exclude laboratory-developed tests.
Vote on Revised Recommendation 1
After revising the wording, 14 Working Group members voted yes to accept the following recommendation. Two votes were made by proxy.
Establish and fund research for sensitive and specific diagnostic tests for acute rickettsial, ehrlichial, and anaplasmal diseases. Encourage development of these tests as *in vitro* diagnostics approved by FDA.
Proposed Recommendation 2
Fund an educational outreach effort across the U.S. with mandatory rickettsial and ehrlichial diseases continuing medical education to inform first-line responders (primary care physicians, advanced practice providers, pediatricians, urgent care providers, and emergency department providers) about the best diagnostic assays to use, best diagnostic samples to collect, and best strategies for treating patients (with a focus on doxycycline) diagnosed with or suspected of having Rocky Mountain spotted fever, human monocytic ehrlichiosis, anaplasmosis, or another tickborne rickettsiosis.
Fund seasonal educational outreach efforts in endemic regions to raise public awareness about rickettsial, anaplasmal, and ehrlichial diseases.
	Encourage accrediting bodies to ensure tickborne diseases education in medical school curricula and graduate medical education and recommend that there be a greater presence of tickborne disease material on licensing examinations and specialty board examinationsDiscussion of Recommendation 2
Members consider Recommendation 2 from several different angles and offered the following suggestions:
Remove the reference to doxycycline so as not to preclude other possible treatments in the future.
	Refrain from using words like “seasonal” and “endemic” because their definitions may be misinterpreted when applied to rickettsial, ehrlichial, and anaplasmal diseases.
	Use caution with words such as “mandatory” because the action may not be enforceable.Members generally agreed that clinician awareness needs to be raised about treating children safely with doxycycline. They also agreed that including frontline responders in the recommendation is important.
Vote on Revised Recommendation 2
After revising the wording, 14 Working Group members voted yes to accept the following recommendation. Two votes were made by proxy.
Fund efforts across the U.S. to expand/require medical education to inform emergency, primary care, and other healthcare providers, and to raise clinician and public awareness of rickettsial (including Rocky Mountain spotted fever), ehrlichial, and anaplasmal diseases.
Proposed Recommendation 3
Establish programs on active surveillance to understand the true geographic representations of rickettsial diseases including programs that survey for changing distributions of medically important tick species and rickettsial pathogens within these species.
Discussion of Recommendation 3
In discussion of recommendation 3, a couple members pointed out that there would be overlap with another recommendation from the Tick Biology, Ecology, and Control Subcommittee calling for enhanced vector surveillance. Other members noted the importance of distinguishing between clinical and tick surveillance and specifying the type of data to be collected (for example, ticks, pathogens, and/or infection rates). Another member commented on potential obstacles to achieving the recommendation, specifically expense and resource limitations, as well as a lack of accurate diagnostics. The group discussed the types of data that are currently collected by CDC through ArboNET. One member noted that it would be ideal to be able to link environmental surveillance with clinical surveillance, but acknowledged that it would be difficult to achieve.
Ben suggested that, given the tools currently available, the recommendation might focus more on funding an acute febrile illness study to better determine the burden of illness associated with the rickettsial, ehrlichial, and anaplasmal pathogens. The group agreed to rephrase the recommendation with the understanding that the environmental surveillance component would be covered under the recommendation by the Tick Biology, Ecology, and Control Subcommittee.
Vote on Revised Recommendation 3
After revising the wording, 14 Working Group members voted yes to accept the following recommendation. Two votes were made by proxy.
Fund prospective acute febrile illness studies to understand burden of tick-borne diseases, including rickettsial, ehrlichial, and anaplasmal pathogens.
Discussion of the Proposed Recommendations from the Ehrlichiosis and Anaplasmosis Subcommittee
After a break for lunch, Ehrlichiosis and Anaplasmosis Subcommittee Co-chairs David Walker and Dennis M. Dixon*,* PhD, Chief, Bacteriology and Mycology Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, HHS, presented their recommendations to the Working Group.
Proposed Recommendation 1
Determine the true number of human cases per year (incidence) and full clinical spectrum, clinical manifestations, and potential complications of human monocytic ehrlichiosis (HME) and human granulocytic anaplasmosis (HGA). Activities that accomplish this include:
Enhance the system of case detection and reporting to capture the true incidence of infections and the specific agents that are causing the infections. Active surveillance is recommended for endemic regions.
	Support expanded participation among health departments in newly available electronic surveillance data submission through Message Mapping Guides, part of CDC’s National Notifiable Diseases Surveillance System Modernization Initiative.Discussion of Recommendation 1
In response to a question about why HME and HGA are being separated from rickettsial diseases, David responded that this recommendation applies to a different group of people and strives to characterize two diseases that are not currently well-characterized.
The Working Group discussed the feasibility of active surveillance and potential obstacles to achieving the recommendation as written. Ultimately, the members decided to focus on funding research with the goal of characterizing HME and HGA. They also discussed various topics related to study design: prospective vs. retrospective; hospital-based vs. clinic-based; patient enrollment; inclusion criteria; follow-up; and challenges and limitations.
Vote on Revised Recommendation 1
After revising the wording, 13 Working Group members voted yes to accept the following recommendation. One vote was made by proxy; one member was absent.
Fund research aimed at characterizing the full clinical spectrum, clinical manifestations, and potential complications of human monocytic ehrlichiosis (HME) and human granulocytic anaplasmosis (HGA).
Proposed Recommendation 2
Fund studies to identify risk factors for severe illness caused by *Ehrlichia* and *Anaplasma* including the presence or absence of specific co-morbidities, patient characteristics (age, gender, and race), immune impairment, and genetic host factors.
Discussion of Recommendation 2
After reviewing the language of revised Recommendation 1 and proposed Recommendation 2, members quickly agreed that these two recommendations could be combined into one. Members modified the language and took a vote.
Vote on Recommendation 2
After revising the wording, 13 Working Group members voted yes to replace the previous recommendation (revised Recommendation 1) with the following. One vote was made by proxy; one member was absent.
Fund research aimed at characterizing the full clinical spectrum, clinical manifestations, and potential complications of human monocytic ehrlichiosis (HME) and human granulocytic anaplasmosis (HGA), including identification of risk factors for severe illness and the importance of specific comorbidities, patient characteristics (age, gender, and race), immune impairment, and genetic host factors.
Proposed Recommendation 3
Support the development of approaches for incorporating data mining and artificial intelligence into health care systems for real-time identification of characteristic signs, symptoms, exposures and laboratory findings of ehrlichiosis and anaplasmosis at the point of patient presentation. Data analytics and systems should be able to access and analyze available clinical and laboratory information within the electronic medical record and provide guidance to clinicians for patient assessment, formulating a differential diagnosis and recommending confirmatory laboratory testing, taking into account local disease prevalence and patient travel history.
Discussion of Recommendation 3
David explained that the purpose of this recommendation is to establish a diagnostic assistance tool to help clinicians evaluate patients with characteristic signs, symptoms, and exposure to specific pathogens. Members noted that this recommendation may overlap with one from the Alpha-Gal Syndrome Subcommittee, which would be presented later in the meeting. In addition, members discussed the following topics.
Making the recommendation more actionable
	Leveraging existing proprietary diagnostic tools and making them interoperable
	Applying the tool to all tick-borne diseases
	Placing this recommendation in a “Looking Forward” section of the reportUltimately, the group decided to table this discussion until the Alpha-Gal Syndrome Subcommittee co-chairs presented their recommendation on a clinical diagnostic tool.
Discussion of the Proposed Recommendations from the Babesiosis and Tick-Borne Pathogens Subcommittee
Babesiosis and Tick-Borne Pathogens Subcommittee Co-Chair Ben Beard presented his subcommittee’s recommendations to the Working Group, as follows.
Proposed Recommendation 1
Provide education to the public and to health care providers, including frontline providers, subspecialists such as emergency departments, OB/GYN, and infectious disease doctors, in addition to family practice, and internal medicine physicians, regarding the clinical manifestations, diagnosis, treatment, transmission, changing disease distribution, and prevention of the broad range of tick-borne illnesses, including particularly babesiosis, tick-borne relapsing fever, emerging tick-borne viral infections, and other low-incidence tick-borne diseases.
Discussion of Recommendation 1
The Working Group agreed that many of the recommendations that call for education will have similarities. Therefore, they decided to adapt the earlier recommendation for rickettsial, ehrlichial, and anaplasmal diseases to this recommendation about babesiosis, tick-borne relapsing fever, emerging tick-borne viral infections, and other low-incidence tick-borne diseases. They also discussed keeping the recommendation on education about Lyme disease (clinical and public) separate from those related to other tick-borne diseases and conditions.
Vote on Revised Recommendation 1
After revising the wording, 13 Working Group members voted yes to accept the following recommendation. One vote was made by proxy; one member was absent.
Fund efforts across the U.S. to expand/require medical education to inform emergency, primary care, and other healthcare providers, and to raise clinician and public awareness of babesiosis, tick-borne relapsing fever, emerging tick-borne viral infections, and other low-incidence tick-borne diseases.
Proposed Recommendation 2
Conduct laboratory, clinical, and field research to address gaps in our capacity to treat and prevent the broader range tick-borne diseases, including particularly babesiosis, tick-borne relapsing fever, Powassan virus infection, and other low-incidence tick-borne diseases. Some of the specific research needs include novel treatment regimens for babesiosis, a better understanding of the vector-pathogen interaction as it affects pathogen transmission, and a better understanding of the ecology and distribution of tick-borne pathogens and their reservoirs, particularly *Babesia duncani*, tick-borne relapsing fever and *Borrelia miyamotoi* agents, and tick-borne viruses particularly Powassan virus.
Discussion of Recommendation 2
One member asked why Powassan virus is specifically called out in Recommendation 2. Ben responded that there is significant concern about Powassan virus in particular at this time, and the recommendation reflects the thoughts of the Babesiosis and Tick-Borne Pathogens Subcommittee members.
Other members suggested trimming the recommendation and placing the more detailed information in the body of the chapter.
Vote on Revised Recommendation 2
After revising the wording, 13 Working Group members voted yes to accept the following recommendation. One vote was made by proxy; one member was absent.
Conduct laboratory, clinical, and field research to address gaps in our capacity to treat and prevent the broad range of tick-borne diseases, including particularly babesiosis, tick-borne relapsing fever, Powassan virus infection, and other low-incidence tick-borne diseases.
Proposed Recommendation 3
Improve diagnostics for the broader range tick-borne diseases, including tick-borne relapsing fever, Powassan virus and other emerging tick-borne viral infections, and other low-incidence tick-borne diseases.
Discussion of Recommendation 3
For consistency, members suggested using language similar to the Rickettsiosis Subcommittee’s first recommendation. A couple members noted that developing new tests does not ensure adoption. To this, Todd suggested including content about incentivizing new diagnostics in the body of the chapter.
Vote on Recommendation 3
After revising the wording, 12 Working Group members voted yes to accept the following recommendation. One vote was made by proxy; two members were absent.
Establish and fund research for sensitive and specific diagnostic tests for the broader range of tick-borne diseases, including tick-borne relapsing fever, Powassan virus, and other emerging tick-borne pathogens. Encourage development of these tests as *in vitro* diagnostics approved by FDA.
Discussion of the Proposed Recommendations from the Alpha-Gal Syndrome Subcommittee
Alpha-Gal Syndrome Subcommittee Co-Chairs Leigh Ann Soltysiak; Scott Palmer Commins, BS, MD, PhD, Associate Professor of Medicine & Pediatrics University of North Carolina; Member, UNC Food Allergy Initiative, Thurston Research Center; and Angel M. Davey, PhD, Program Manager, Tick-Borne Disease Research Program, Congressionally Directed Medical Research Programs, U.S. Department of Defense, presented their subcommittee’s recommendations to the Working Group, as follows.
Proposed Recommendation 1
[Short-term, 1-2 years] Congress to provide funding/support/resources necessary to create a National Tick-Borne Disease Health Alert that is focused on awareness, prevention, and education of most common TBDs and rare and emerging TBDs (e.g., Alpha-gal Syndrome), and that targets key stakeholder groups *(public, patients, healthcare providers, professional medical societies/associations, state and county health departments)*
	[Short-term, 1-2 years] Congress to direct FDA and USDA to require labeling of foods/beverages, medications and medical products, cosmetics, etc. containing mammalian-derived components for the safety of consumers with Alpha-gal Syndrome (output of Health Alert)Discussion of Recommendation 1
Given the general lack of awareness about alpha-gal syndrome—both among clinicians and the public—Working Group members agreed that both parts of the recommendation are critical and that the Federal agencies are a key component of implementing them. A few members commented that this recommendation should be focused on alpha-gal syndrome because it is different from other tick-borne diseases. Regarding part A, Leigh Ann explained that the scope of the recommended health alerts should be broad, frequent, and far-reaching to include as many stakeholders as possible. Regarding part B, Todd explained how FDA is involved with product labeling.
Questions that came up during the discussion include the following:
Should part A be restricted to the lone star tick (*Amblyomma americanum*)?
	Could part A be implemented now, simply by working with Federal partners?
	If yes, should the recommendation focus solely on part B (product labeling)?The questions were not entirely resolved, so the group agreed to take a vote on the recommendation below with the understanding that it may be refined later in the meeting.
Vote on Revised Recommendation 1
After revising the wording, 11 Working Group members voted yes to accept the following recommendation. One vote was made by proxy; two members abstained; one member was absent.
Generate broad awareness regarding alpha-gal syndrome through the following two mechanisms:
Provide funding/support/resources necessary to create a National Tick-Borne Disease Health Alert that is focused on awareness, prevention, and education regarding tick-associated alpha-gal syndrome and that targets key stakeholder groups.
	Label foods/beverages, medications and medical products, cosmetics, etc. containing mammalian-derived components for the safety of consumers with alpha-gal syndrome.Proposed Recommendation 2
[Short-term, 1-2 years] Congress to provide HHS with resources to partner with national Integrated Delivery Networks (IDNs) (e.g., Geisinger, Kaiser, etc.) to leverage Electronic Medical Records (EMRs) at the patient point-of-care.  Specifically, patient EMR charts are ‘flagged’ for provider awareness using Best Practice Alerts to highlight TBD risk factors, co-morbidities, geographic risk, patient symptoms, results of clinical evaluation, etc., to better guide diagnosis and treatment, as well as provide real-world evidence to support the design of clinical research/trials.
Discussion of Recommendation 2 and the Previously Tabled Recommendation
A few members expressed concern about Recommendation 2, citing that it may violate regulations set forth in the Health Insurance Portability and Accountability Act (HIPAA) depending on how patients’ personally identifiable information (PII) would be used. Scott C. clarified that the intention is not to collect any PII; rather, the recommendation calls for development of a point-of-care diagnostic tool to prompt clinicians to consider alpha-gal syndrome if patients present with characteristic symptoms, such as febrile illness and anaphylaxis at night, with no history of allergy, and is in an endemic area of alpha-gal syndrome. He added that it would be based on best practices already developed for clinicians who treat patients with diabetes. He further stated that no patient information would be entered into the system, and there would be no way to track which patient was involved in the diagnostic process. However, to ensure that the recommendation would not negatively impact Lyme disease patients, he agreed to restrict it to alpha-gal syndrome.
At this point, the Working Group brought up the recommendation from the Ehrlichiosis and Anaplasmosis Subcommittee that had been tabled earlier in the meeting and which members had agreed might overlap with Recommendation 2 from the Alpha-Gal Syndrome Subcommittee. Members discussed the feasibility of implementing either recommendation in the near term. Ben suggested that the recommendation focus on conducting feasibility studies to assess how a diagnostic tool might work in terms of efficacy, potential privacy, and the development of quality measures and condition-dependent triggers. The group generally agreed to take this approach.
Vote on Recommendation 2
After revising the wording, 12 Working Group members voted yes to accept the following recommendation. One vote was made by proxy; one member abstained; and one member was absent.
Provide HHS with resources to partner with national Integrated Delivery Networks (IDNs) (e.g., Geisinger, Kaiser, etc.) to conduct a pilot feasibility study to leverage Electronic Medical Records (EMRs) using Best Practice Alerts at the patient point-of-care for Alpha-gal Syndrome in endemic areas (upholding patient confidentiality).
Continued Discussion of the Previously Tabled Recommendation
Members reviewed the language in the previously tabled recommendation from Ehrlichiosis and Anaplasmosis Subcommittee, as follows:
Support the development of approaches for incorporating data mining and artificial intelligence into health care systems for real-time identification of characteristic signs, symptoms, exposures and laboratory findings of specific tick-borne diseases at the point of patient presentation. Data analytics and systems should be able to access and analyze available clinical and laboratory information within the electronic medical record and provide guidance to clinicians for patient assessment, formulating a differential diagnosis and recommending confirmatory laboratory testing, taking into account local disease prevalence and patient travel history.
A motion was made and seconded to accept the recommendation as is. However, a few members suggested revising the motion, so that the recommendation could be changed to include the language that had just been agreed upon for alpha-gal syndrome, but applying to rickettsiosis, ehrlichiosis, and anaplasmosis. The motion was revised and seconded, and the Working Group took a vote. The group then voted to accept the newly revised, previously tabled recommendation.
Vote on the Revised Tabled Recommendation
After revising the wording, 11 Working Group members voted yes to accept the following recommendation. One member abstained; two members were absent.
Provide HHS with resources to partner with national Integrated Delivery Networks (IDNs) (e.g., Geisinger, Kaiser, etc.) to conduct a pilot feasibility study to leverage Electronic Medical Records (EMRs) using best practice alerts at the patient point-of-care for rickettsia, ehrlichiosis, and anaplasmosis in endemic areas (upholding patient confidentiality).
Proposed Recommendation 3
[Mid-term, 2-4 years] Congress to provide HHS with resources necessary to fund basic science research and clinical research to investigate the pathology of the human immune response following tick bites that result in:
Most common TBDs
	Rare and emerging TBDs (e.g., Alpha-gal Syndrome)with HHS initiating a rapid response by facilitating collaboration (with support from NIH, partners, industry) and multiple, concurrent research programs to expedite outcomes.
Discussion of Recommendation 3
The Working Group then transitioned to the third recommendation put forth by the Alpha-Gal Syndrome Subcommittee co-chairs. David asked what is meant by “rapid response” to which Angel explained that results would be achieved more quickly through collaborative efforts or through multiple concurrent programs.
Members discussed how such a recommendation would be implemented within the Federal agencies and whether or not to restrict the recommendation to alpha-gal syndrome or to lone star ticks (*A. americanum*). Angel noted that public commenters have stressed the need for research of immune response in many tick-borne diseases. Others commented that alpha-gal syndrome can be caused by ticks other than *A. americanum*. The group, therefore, agreed to keep the recommendation broad and inclusive of other tick-borne diseases and ticks.
Vote on Revised Recommendation 3
After revising the wording, 13 Working Group members voted to accept the following recommendation. One vote was made by proxy; one member was absent.
Provide HHS with resources necessary to fund basic science research and clinical research to investigate the pathology of the human immune response following tick bites (e.g., Alpha-gal Syndrome).
Discussion of the Proposed Recommendations from the Training, Education, Access to Care, and Reimbursement Subcommittee
Training, Education, Access to Care, and Reimbursement Subcommittee Co-Chairs Patricia (Pat) Smith and CAPT Scott J. Cooper (Coop)*,* MMSc, PA-C, Senior Technical Advisor and Lead Officer for Medicare Hospital Health and Safety Regulations, Centers for Medicare and Medicaid Services, HHS (Alternate present), presented their recommendation to the Working Group, as follows.
Proposed Recommendations
[Website disclosure related to access to care and shared medical decision-making] Recommend the disclosure on all Federal and state government websites and educational materials and seminars for clinicians, the public, and public health departments that discuss Lyme disease or tick-borne diseases, including CDC, NIH, AHRQ, that the state of the science in Lyme disease, particularly for persistent Lyme disease, is limited, emerging, and unsettled; and increase public awareness that there are two divergent diagnostic and treatment approaches reflected in guidelines for Lyme disease and that shared medical decision-making may be appropriate in some circumstances.
	[Surveillance revisions related to access to care] Recommend that CDC provide input to the Council of State and Territorial Epidemiologists, CSTE, that the Lyme disease surveillance case definition should be revised such that it abandons the use of geographic parameters for Lyme disease; and that CDC, NIH, and other government agency websites, brochures, and educational materials abandon the use of geographic parameters for the diagnosis of Lyme disease and inform clinicians and the public that Lyme disease has been reported in all states. Recommend that funding be provided to the CDC to streamline the surveillance process and reduce the burden on clinicians and public health departments including by permitting direct laboratory reporting of positive cases from FDA approved and/or CLIA certified diagnostic labs to obtain a more accurate understanding of the geographic exposure and growth in the incidence of Lyme disease and other tick-borne diseases.
	[Clinician training related to access to care, clinician training on tick-borne diseases, and meaningful patient representation] Fund and support a directive for CDC to develop (either directly or through an approved federal contract) a multi-leveled and nationwide curriculum on Lyme disease for clinicians-in-training as well as continuing medical education modules for practicing clinicians. The US military must also be funded to participate in this CDC-directed nationwide training and education on Lyme disease and other tick-borne diseases.The curriculum must focus on enhancing clinicians’ ability to 1) recognize the various clinical presentations of tick-borne diseases and 2) avoid misdiagnoses by highlighting the most frequent sources of diagnostic errors: inappropriately excluding Lyme disease because of geographic exclusions that inaccurately reflect the geographic scope of the disease; failing to recognize the full spectrum of Lyme disease-related symptoms; failing to identify *erythema migrans* rashes and/or other Lyme disease-related findings on physical exam; and failing to caution against over-reliance on inaccurate diagnostic tests. The curriculum development team must include representatives of all stakeholder groups, including meaningful patient representation as well as representation by clinical and/or patient members. Clinicians and research scientists with expertise in the field should be selected such that the team represents the full spectrum of scientific and clinical perspectives on Lyme and other tick-borne diseases.
Discussion of Recommendation 1
When asked if the intent of the recommendation was to have both the IDSA and ILADS guidelines published on Federal websites, Pat clarified that the intention is to have Federal agencies acknowledge that that there are two diagnostic and treatment approaches reflected in the guidelines. Coop further elucidated that this recommendation would only apply to websites that already contain content related to Lyme disease treatment guidelines.
Some members representing Federal agencies expressed their concerns about this recommendation, citing their discomfort with directing agencies about what information to include on their websites. This led to a discussion of what content is currently posted on the NIH and CDC websites and the rationale behind those content decisions.
At this point, the building in which the meeting was held was closed, and the remainder of the discussion was postponed to Day 2.
Adjournment
The meeting was adjourned at 6:18 pm Eastern.
Appendix 1: Tick-Borne Disease Working Group Members
**In alphabetical order:**
Co-Chair
*Leigh Ann Soltysiak*, MS, Owner, Principal, Silverleaf Consulting, LLC; Adjunct Professor, Stevens Institute of Technology, Entrepreneurship Thinking (Present)
**Co-Chair**
*David Hughes Walker*, MD, Professor, Department of Pathology, the Carmage and Martha Walls Distinguished University Chair in Tropical Diseases; Executive Director, UTMB Center for Biodefense and Emerging Infectious Diseases (Present)
*Charles Benjamin (Ben) Beard*, PhD, Deputy Director, Division of Vector-Borne Diseases, Centers for Disease Control and Prevention, HHS; Associate Editor, Emerging Infectious Diseases (Present)
*CDR Rebecca Bunnell*, MPAS, PA-C, Senior Advisor, Learning and Diffusion Group, Innovation Center, Centers for Medicare and Medicaid Services, U.S. Department of Health and Human Services (Absent) – *CAPT Scott J. Cooper,* MMSc, PA-C, Senior Technical Advisor and Lead Officer for Medicare Hospital Health and Safety Regulations, Centers for Medicare and Medicaid Services, U.S. Department of health and Human Services (Alternate present)
*Scott Palmer Commins*, BS, MD, PhD, Associate Professor of Medicine & Pediatrics
	University of North Carolina; Member, UNC Food Allergy Initiative, Thurston Research Center (Present intermittently via phone; Designated proxy: Angel Davey)
*Angel M. Davey*, PhD, Program Manager, Tick-Borne Disease Research Program, Congressionally Directed Medical Research Programs, U.S. Department of Defense (Present)
*Dennis M. Dixon*, PhD, Chief, Bacteriology and Mycology Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, U.S. Department of Health and Human Services (Present) - *Samuel (Sam) S. Perdue,* PhD, Section Chief, Basic Sciences and Program Officer, Rickettsial and Related Diseases, Bacteriology and Mycology Branch, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, U.S. Department of Health and Human Services (Alternate present)
*Sam T. Donta*, MD, Professor of Medicine (retired); Consultant, Infectious Diseases (Present by phone)
*RADM Estella Jones*, DVM, Deputy Director, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, U.S. Department of Health and Human Services (Absent) – *CDR Todd Myers*, PhD, HCLD (ABB), MB (ASCP), Office of Counterterrorism and Emerging Threats, Office of the Chief Scientist, Office of the Commissioner, U.S. Food and Drug Administration, U.S. Department of Health and Human Services (Alternate present)
*Kevin R. Macaluso*, PhD, MS, Locke Distinguished Chair, Chair of Microbiology and Immunology, College of Medicine, University of South Alabama (Present)
*Adalberto (Beto) Pérez de León*, MS, PhD, Director, Knipling-Bushland U.S. Livestock Insects Research Laboratory, United States Department of Agriculture—Agricultural Research Service (Present)
*Eugene David Shapiro,* MD, Professor of Pediatrics, Epidemiology, and Investigative Medicine, Yale University School of Medicine; Vice Chair for Research, Department of Pediatrics; Co-Director of Education, Yale Center for Clinical Investigation; Deputy Director, Yale PhD Program in Investigative Medicine (Absent; Designated proxy: David Walker)
*Patricia V. Smith*, President, Lyme Disease Association, Inc. (Present
*Leith Jason States**,* MD, MPH (FMF), Deputy Chief Medical Officer, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services (Absent) – Shahla Jilani, MD, Deputy Chief Medical Officer, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services (Alternate present)
Appendix 2: HHS Support Staff
**In alphabetical order:**
*James (Jim) Berger*, MS, MT (ASCP), SBB, Designated Federal Officer, Tick-Borne Disease Working Group Senior Blood and Tissue Policy Advisor, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
*Jordan Broderick*, MA, Health Communication Specialist, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
*Kaye Hayes*, MPA, Alternate Designated Federal Officer, Tick-Borne Disease Working Group, Executive Director, Presidential Advisory Council on HIV/AIDS, Principal Deputy Director, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
*Chinedu Okeke*, MD, MPH-TM, MPA, Senior Policy Advisor, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
*Allison Petkoff,*ORISE Policy Fellow, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
*Debbie Seem*, RN, MPH, Public Health Advisor, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
Appendix 3: Subcommittee Co-Chairs
Alpha-Gal Subcommittee
*Scott Palmer Commins,*BS, MD, PhD, Associate Professor of Medicine & Pediatrics
	University of North Carolina; Member, UNC Food Allergy Initiative, Thurston Research Center
*Angel M. Davey,* PhD, Program Manager, Tick-Borne Disease Research Program, Congressionally Directed Medical Research Programs, U.S. Department of Defense
*Leigh Ann Soltysiak,* MS, Owner, Principal, Silverleaf Consulting, LLC; Adjunct Professor, Stevens Institute of Technology, Entrepreneurship Thinking
Babesiosis and Tick-Borne Pathogens Subcommittee
*Charles Benjamin (Ben) Beard,* PhD, Deputy Director, Division of Vector-Borne Diseases, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services; Associate Editor, Emerging Infectious Diseases
*Eugene David Shapiro,* MD, Professor of Pediatrics, Epidemiology, and Investigative Medicine, Yale University School of Medicine; Vice Chair for Research, Department of Pediatrics; Co-Director of Education, Yale Center for Clinical Investigation; Deputy Director, Yale PhD Program in Investigative Medicine
Clinical Aspects of Lyme Disease Subcommittee
*CDR Rebecca Bunnell,* MPAS, PA-C, Senior Advisor, Learning and Diffusion Group, Innovation Center, Centers for Medicare and Medicaid Services
*Sam T. Donta,* MD, Professor of Medicine (retired); Infectious Disease Consultant, Falmouth Hospital
Ehrlichiosis and Anaplasmosis Subcommittee
*Dennis M. Dixon,* PhD, Chief, Bacteriology and Mycology Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, U.S. Department of Health and Human Services
*David Hughes Walker*, MD, Professor, Department of Pathology, the Carmage and Martha Walls Distinguished University Chair in Tropical Diseases; Executive Director, UTMB Center for Biodefense and Emerging Infectious Diseases
Pathogenesis and Physiology of Lyme Disease
*Sam T. Donta,* MD, Professor of Medicine (retired); Consultant, Infectious Diseases
*Leith Jason States*, MD, MPH, Acting Chief, Medical Officer, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
Rickettsiosis Subcommittee
*CAPT Estella Jones,* DVM, Deputy Director, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, U.S. Department of Health and Human Services (Absent)
*CDR Todd Myers,* PhD, Office of the Chief Scientist, Office of Counter Terrorism and Emerging Threats, Food and Drug Administration (Alternate present)
*David Hughes Walker,* MD, Professor, Department of Pathology, the Carmage and Martha Walls Distinguished University Chair in Tropical Diseases; Executive Director, UTMB Center for Biodefense and Emerging Infectious Diseases
Tick Biology, Ecology, and Control
*Adalberto (Beto) Pérez de León,*MS, PhD, Director, Knipling-Bushland U.S. Livestock Insects Research Laboratory, United States Department of Agriculture—Agricultural Research Service
*Kevin R. Macaluso,* PhD, MS, Locke Distinguished Chair, Chair of Microbiology and Immunology, College of Medicine, University of South Alabama
Training, Education, Access to Care, and Reimbursement
*Patricia V. Smith,* President, Lyme Disease Association, Inc.
*CDR Rebecca Bunnell*, MPAS, PA-C, Senior Advisor, Learning and Diffusion Group, Innovation Center, Centers for Medicare and Medicaid Services, U.S. Department of Health and Human Services (Absent)
C*APT Scott J. Cooper,* MMSc, PA-C, Senior Technical Advisor and Lead Officer for Medicare Hospital Health and Safety Regulations, Centers for Medicare and Medicaid Services, U.S. Department of health and Human Services (Alternate present)

                    
  


Content created by Office of Infectious Disease and HIV/AIDS Policy (OIDP) Content last reviewed April 21, 2020Back to top
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