Report of the Access to Care Services and Support to Patients Subcommittee to the Tick-Borne Disease Working Group

Background
Methods
Results
Summary of Subcommittee Report to the Working Group
Appendix 1: References by Topic 
Appendix 2: Subcommittee Agendas and Top Line Summaries
Appendix 3: Informed Consent for Treatment of Persistant Lyme Disease
Appendix 4: The "Lyme Literate" Mental Health Evaluation

Information and opinions in this report do not necessarily reflect the opinions of the working group, the U.S. Department of Health and Human Services, or any other component of the federal government. Readers should not consider the report or any part of it to be guidance or instruction regarding the diagnosis, care, or treatment of tick-borne diseases or to supersede in any way existing guidance. All subcommittee members actively participated in the development of this report. Members voted to approve submission of the report to the Working Group and on the wording of each of the possible actions contained in the report. The vote to submit the report indicates general agreement with the content of the document, but it does not necessarily indicate complete agreement with each and every statement in the full report.

Background

This subcommittee was tasked by the TBDWG with investigating any and all factors that might be helping or hindering patients with Lyme and other tick-borne diseases (TBDs) with regard to accessing care, which includes diagnosis and treatment of the disease(s) as well as any associated symptoms and co-infections, and support before and after diagnosis and treatment. To guide its investigation of these factors and inform our areas of focus, the subcommittee relied on: the expertise and experience of its members; presentations to the subcommittee by specific subject matter experts; a review of the available literature, especially any peer-reviewed research; and discussions of the various issues identified on our weekly subcommittee calls. Through this process, we identified several priority themes and issues that this subcommittee believes significantly impact Lyme/TBD patients in their attempts to readily access affordable and effective care and support. These themes and issues include, but are not limited to:

• The current state of patient access to care and the support available through patient advocacy groups, state and federal assistance programs, and free educational programs;
• Education and awareness for patients, their loved ones, and the general public, including historically underrepresented and high-risk patient populations such as children, low-income individuals, the elderly, the military and their family members, migrant workers, etc.;
• Legislation to protect the rights of patients and to protect practitioners who treat patients based on their clinical judgment from disciplinary action by state medical license boards;
• Basic and continuing medical education on Lyme and other TBDs for healthcare providers in multiple disciplines (e.g., primary care, cardiology, behavioral health, infectious disease, rheumatology, neurology, etc.);
• Current obstacles to affordable medical care, including inappropriate use by practitioners of CDC surveillance criteria as the standard for clinical diagnosis, denial by insurance companies for reimbursement of treatment/services based on same CDC criteria, costly and ineffective treatments by exploitive and unscrupulous practitioners, competing guidelines for treatment and care without a common and established standard of care (e.g., IDSA versus ILADS guidelines with current governmental and insurance industry preference for IDSA); and
• Proper and affordable diagnosis and treatment, especially the availability of reliable diagnostic testing, and including insurance coverage for mainstream and complementary treatment options, practitioner recognition of acute versus late-stage (including neuro-psychiatric manifestations) versus chronic disease versus post-treatment disorder, long-term recovery and support.

Table 1: Members of the Access to Care & Patient Support Subcommittee

Member	Type	Stakeholder Group	Expertise
(Co-Chair) Commander Scott J. Cooper, MMSc, PA-C, U.S. Public Health Service, Baltimore, MD	Federal		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
(Co-Chair) Paula Jackson Jones, Newcastle, ME Selected on 3/14/18	Public	Advocate, patient	President and Co-Founder, Midcoast Lyme Disease Support and Education
Karen Vanderhoof-Forschner Previous Co-Chair, resigned 3/6/18	Public	Advocate
Robert Bransfield, MD, DLFAPA, Red Bank, NJ	Public	Provider	Private Practice; Associate Professor, Department of Psychiatry, Rutgers-RWJ Medical School
Sherrill Franklin, West Grove, PA Joined April 24, 2018	Public	Advocate, patient	Advocate for better diagnostic tools and definitive treatments for tick-borne diseases
Anna Frost, PhD, Port Orchard, WA	Public	Researcher, patient	Lyme disease researcher
Holiday Goodreau, Denver, CO	Public	Advocate	President and Executive Director, The LivLyme Foundation
Enid Haller, LCSW, PhD, Holliston, MA Exited the role on April 24, 2018	Public	Advocate, patient	Executive Director, Lyme Center of Martha's Vineyard
Colonel Nicole Malachowski, Springfield, VA	Public	Patient	Retired, U.S. Air Force
Leonard Schuchman, DO, MPH, FAAFP, Mount Laurel, NJ	Public	Provider	Family Practitioner
Sheila M. Statlender, PhD, Newton Centre, MA	Public	Provider, patient	Clinical Psychologist, Private Practice; Chair, Massachusetts Lyme Legislative Task Force
Kathleen Steele, LCSW, San Carlos, CA	Public	Provider	Psychotherapist

Table 2: Overview of Access to Care & Patient Support Subcommittee Meetings, 2018

Meeting No.	Date	Present	Topics Addressed
1	February 28, 2018	Kristen Honey, Scott J. Cooper, Karen Vanderhoof-Forschner, Anna Frost, Robert Bransfield, Enid Haller, Paula Jackson Jones, Nicole Malachowski, Leonard Schuchman, Sheila Statlender, Kathleen Steele, Richard Wolitski, Cat Thomson	Discussed the preparation of materials for the working group; troubleshot some technical issues around group communication and information sharing; focused on identifying, clarifying, and organizing key themes, issues, and questions that affect access to care and support to patients suffering from tick-borne diseases.
2	March 7, 2018	Kristen Honey, Scott J. Cooper, Anna Frost, Robert Bransfield, Holiday Goodreau, Enid Haller, Paula Jackson Jones, Nicole Malachowski, Leonard Schuchman, Kathleen Steele, Richard Wolitski, Cat Thomson	Agreed to vote anonymously via email for a new non-federal co-chair; outlined the process for voting and decision-making in general; discussed timeline and deliverables; began deciding who would write about the group's six issues/priorities; discussed the process for using Sharepoint and engaging speakers; agreed to develop a workplan.
3	March 14, 2018	Kristen Honey, Scott J. Cooper, Anna Frost, Holiday Goodreau, Enid Haller, Paula Jackson Jones, Nicole Malachowski, Leonard Schuchman, Sheila Statlender, Kathleen Steele, Richard Wolitski, Cat Thomson	Reviewed and discussed Vision, Values, Ethics pledge; discussed unity/division in the Lyme community, specifically within patient advocacy; announced new co-chair; reviewed timeline and deliverables; discussed division of six priorities and workplan
4	March 28, 2018	Kristen Honey, Scott J. Cooper, Paula Jackson Jones, Anna Frost, Holiday Goodreau, Enid Haller, Nicole Malachowski, Leonard Schuchman, Sheila Statlender, Kathleen Steele, Richard Wolitski, Cat Thomson	The Access to Care Services and Support to Patients subcommittee spent most of the meeting discussing communication as well as their Issues and Priorities work plan (see summary of their discussion below). In addition, they made some initial decisions about which topics each member would write about. They worked to ensure all of the members could access the available collaboration tools with which to do the writing. And they made suggestions for guest speakers who could address gaps in their collective knowledge.
5	April 4, 2018	Kristen Honey, Scott J. Cooper, Paula Jackson Jones, Robert Bransfield, Anna Frost, Holiday Goodreau, Enid Haller, Nicole Malachowski, Sheila Statlender, Richard Wolitski, Cat Thomson	The Access to Care Services and Support to Patients subcommittee briefly discussed speakers they would like to have present at the remainder of their meetings. They also heard from the Designated Federal Officer about some of the Tick-Borne Disease Working Group processes and discussed topics to include in their report to the working group. The topics they discussed are summarized below.
6	April 18, 2018	Scott J. Cooper, Paula Jackson Jones, Robert Bransfield, Anna Frost, Holiday Goodreau, Enid Haller, Nicole Malachowski, Leonard Schuchman, Sheila Statlender, Kathleen Steele, Richard Wolitski, Jennifer Gillissen, Cat Thomson	The subcommittee received updates from the Tick-Borne Disease Working Group leadership and discussed using collaboration tools. They also heard from the following three speakers, along with the topics of their presentations: Betty Maloney, MD - Physician education and access to care; Scott Santarella - Testing initiatives; Mary Beth Pfeiffer - experience as an investigative reporter researching Lyme disease
7	April 25, 2018	Kristen Honey, Scott J. Cooper, Paula Jackson Jones, Sherrill Franklin, Anna Frost, Holiday Goodreau, Nicole Malachowski, Sheila Statlender, Kathleen Steele, Richard Wolitski, James Berger, Cat Thomson	The subcommittee welcomed a new member, Sherill Franklin. They also received updates from the Tick-Borne Disease Working Group leadership and then heard the following three presentations: Bennett Nemser - Cohen Lyme and Tickborne Disease Initiative; Susan Green - helping patients empower themselves to handle insurance company denials & working to change state laws; Nevana Zubcevik, MD - Access to care challenges
8	May 2, 2018	Scott J. Cooper, Paula Jackson Jones, Sherrill Franklin, Anna Frost, Holiday Goodreau, Nicole Malachowski, Sherrill Franklin, Richard Wolitski, Jennifer Gillissen, Cat Thomson	The subcommittee spent the meeting listening to the following three presenters: Lorrain Johnson - MyLymeData project; Tammy Crawford - Chronic Lyme sample blood bank; Richard Horowitz, MD - Physician perspective on access to care
9	May 3, 2018	Kristen Honey, Scott J. Cooper, Paula Jackson Jones, Sherrill Franklin, Anna Frost, Holiday Goodreau, Sheila Statlender, Richard Wolitski, Cat Thomson	The subcommittee spent the entire meeting reviewing and discussing their report to the Tick-Borne Disease Working Group. Specifically, they discussed the potential actions they felt should be included in the report.

Table 3: Presenters to the Access to Care & Patient Support Subcommittee

Meeting No.	Presenter	Topics Discussed
6	Betty Maloney, MD, Minnesota Lyme activist and President of Partnership for Healing & Health	Physician education and access to care
6	Scott Santarella, Global Lyme Alliance	Testing initiatives
6	Mary Beth Pfeiffer, Author	Experience as an investigative reporter researching Lyme disease
7	Bennett Nemser, Epidemiology, Senior Program Officer, Cohen Lyme Foundation	Cohen Lyme and Tickborne Disease Initiative
7	Susan Green, Legislative Counsel NatCapLyme	Helping patients empower themselves to handle insurance company denials & working to change state laws
7	Nevana Zubcevik, MD, Dean Center, Spaulding Rehabilitation Network	Access to care challenges
8	Lorrain Johnson, LymeDisease.org	MyLymeData project
8	Tammy Crawford, Executive Director, Focus on Lyme	Chronic Lyme sample blood bank
8	Richard Horowitz, MD, Hudson Valley Healing Arts Center	Physician perspective on access to care

Table 4: Votes Taken by the Access to Care & Patient Support Subcommittee

Meeting or Date	Motion	Results	Minority Response
3/2/17	First vote on which Issues & Priorities document (A or B) to send to Working Group	0 of votes in favor of A. 8 of votes in favor of B. 1 person formally abstained. 2 failed to vote even after being contacted by a co-chair. Version B was submitted to Working Group.	n/a
3/14/17	Select new subcommittee co-chair	6 votes in favor of Paula Jackson Jones. 4 votes in favor of Enid Haller. Paula Jackson Jones was sworn in as co-chair.	n/a
5/4/18	Vote via email to approve the final Results section of the report, including all Potential Actions	9 votes in favor by email. 1 abstained.	n/a

Methods

The Chair and Vice-Chair of the Working Group selected two members for each subcommittee to serve as co-chairs (see Table 1). One was a federal employee (Commander Scott Cooper) and the other was a member of the public (Karen Vanderhoof-Forschner, later replaced by Paula Jackson Jones). If one of the members was not able to take on the co-chair duties, subcommittee members were selected by the single co-chair in active consultation with the Chair and Vice-Chair from among the subcommittee members.

Subcommittee members were selected from a total of 220 nominations that were received from people who had nominated themselves to either one of the requests that were published in the Federal Register to serve on the Working Group or on a subcommittee. Of these, a total of 68 people expressed interest in the Access to Care Services and Support to Patients subcommittee. These nominees were considered using a two-stage process. First, the co-chairs reviewed all of the nominations and identified the people who have experience related to helping patients with tick-borne diseases, as well as some knowledge of the specific content of the subcommittee(s) of their choice. In addition, the co-chairs ensured that the perspectives of patients and other key stakeholders outlined in the 21^st Century Cures Act were identified during the first round of review. Subsequently, the co-chairs discussed the identified individuals to select the best well-rounded and diverse candidates for the subcommittee. This list was sent to the TBDWG and the individuals selected were contacted and determined if they would participate in the Access to Care Services and Support to Patients subcommittee. Nine individuals consented to working on the subcommittee and thus became members of the subcommittee. On April 24, 2018, Enid Haller was replaced by Sherrill Franklin. The total composition of the subcommittee is shown in Table 1.

The key characteristics of subcommittee co-chairs and members (e.g., professional expertise, past experience addressing these issues, patient, family member, etc.) are outlined in Table 1. Table 1 also demonstrates that one of the eleven members of the subcommittee represented a federal partner (U.S. Public Health Service) while nine of the ten members represented a non-federal perspective.

From February 28 to May 3, 2018, subcommittee members met by teleconference and webinar each Wednesday from approximately 2:00 pm to 4:00 pm EST (Table 2). In the early stages, the subcommittee developed a process for collaborating on their report to the Tick-Borne Disease Working Group and voting on various actions and issues. The members also used email to organize their efforts and vote.

The subcommittee's first milestone was to identify important issues and priorities related to Access to Care Services and Support to Patients that they then organized into key themes. The members volunteered to work in smaller groups, each of which was devoted to writing about one of the themes. Meanwhile, the subcommittee created a workplan to outline their approach to doing the work. Once everyone had written their sections, they were compiled into one document for review and revision. The group also met by phone to determine what Potential Actions to include in their report. They then voted on the Results section and submitted their final report to the Tick-Borne Disease Working Group.

Results

Note: Where not noted in the text, references are organized by topic in Appendix 1: References by Topic.

Key Theme #1: Access to Care Services and Support - Past

Issue #1: How did we get here?

Background

Access to care for Lyme and other tick-borne diseases is dependent upon a number of considerations. This includes the recognition of the disease, the recognition of the seriousness of the disease, the capability to diagnose the disease, the treatment capability, the education of a sufficient number of healthcare providers, the capacity to pay for the cost of assessment and treatment and the availability of adequate diagnosis and treatment for the general population. There have been challenges in all of these areas. It is particularly difficult to have access to care for a condition that some believe does not exist.

The recognition of Lyme

The recognition of Lyme and tick-borne diseases has followed a slow and convoluted path. Lyme is an ancient disease and the Lyme Borrelia has been found in 15 million-year-old fossilized ticks and in the 5,300-year-old Iceman in the Italian Alps. Josselyn stated that there was "an infinite number of ticks" in America in 1638. The disease was first described in Scotland in 1794. The erythema migrans rash was first described by Afselius in Sweden in 1909 and by Scrimenti in Wisconsin in 1970. Polly Murray drew critical attention to the disease in Lyme, Connecticut in 1975, and Willy Burgdorfer identified the causative agent.

A number of highly defended conceptual errors occurred that delayed forward progress. These errors include statements such as these:

• Lyme disease is caused by a virus;
• Lyme is mostly a mostly arthritic disease.
• Lyme disease is treated with steroids.
• Short courses of antibiotic treatment are sufficient.
• Lyme disease is self-limiting; chronic symptoms are little more than the aches and pains of daily living.
• Chronic Lyme does not exist.
• The two-tier testing is accurate.
• There are no psychiatric manifestations.
• The geographical scope is very limited and the highly restrictive.
• Surveillance criteria can be used as diagnostic criteria.

The recognition of the seriousness of the disease

The position taken by policymakers focuses upon side effects of antibiotic treatments and antibiotic stewardship rather than the seriousness of the disease. In reality, Lyme and tick-borne diseases cause a significant number of deaths, disability, pain, and suffering.

The capability to diagnose the disease

The diagnosis of any disease requires a thorough clinical assessment, a knowledge of the best science available, clinical judgment, and a consideration of patient preferences. Due to the complexity of Lyme and associated tick-borne diseases, a proper assessment is labor intensive on the part of the examining physician. It is highly illogical to put excessive reliability upon any immune-based test when diagnosing an infection that is known to suppress and evade the immune system. Many of the lab tests covered by insurance companies are of poor quality while many of the more proficient labs are not covered by most private insurance companies.

The treatment capability

Borrelia is the most complex known bacteria and therefore requires a more complex treatment. Since there are many variables in coinfections, susceptibility, pathophysiology, and clinical presentations, it is very challenging to design proper studies to evaluate effective treatments of such a heterogeneous group. Two major treatment options are antibiotic treatments and therapies aimed at treating the symptoms resulting from the infection. Although rigid treatment protocols are advocated by some, they are ineffective; individualized treatments appear to be more effective.

The education of a sufficient number of healthcare providers

The complexity and controversy of the disease encourages many healthcare providers to attempt to avoid dealing with Lyme disease. Compounding the issue, some of the educational programs disseminate inaccurate information. This results in a shortage of healthcare providers who are willing and able to treat the disease.

The capacity to pay for the cost of assessment and treatment

Since adequate assessment and treatment requires a considerable amount of time and effort on the part of the treating healthcare professional, this adds to the cost of treatment. Insurance reimbursement systems do not make adjustments for the higher level of care needed by these patients. As a result, physicians who provide adequate care cannot function within the restraints of insurance company network requirements, and physicians who provide adequate care can rarely function within the restraints of insurance companies. Since insurance companies invariably use the lowest criteria for treatment, many of the antibiotics and other needed treatments are often not covered. This leads to the need for private pay for many of the necessary treatments, which many patients cannot afford, especially while they are disabled from the illness.

The availability of adequate diagnosis and treatment for the general population

It is difficult for all patients to understand how to access care for Lyme disease, regardless of their financial resources, but especially when they are suffering from fatigue, cognitive impairments, psychiatric symptoms and disability. The complexity, controversies, and costs involved in properly diagnosing and treating Lyme and other tick-borne diseases have made access to proper and affordable care available to very few. A greater recognition of Lyme and tick-borne diseases, a proper response to them, and improved access to care can help prevent unnecessary suffering, disability, death, developmental impairments, learning disabilities, mental illnesses, suicides, violence, general medical illnesses, and economic and non-economic costs (Bransfield, 2017; Bransfield, 2018a; Hamlen & Kliman, 2007; Johnson, Wilcox, Mankoff, & Stricker, 2014; Statlender, 2016; Zhang et al., 2006).

Key Theme 2: Access to Care and Patient Support - Present

Issue #2: What is the current state of access to care and which supports are available to patients & families?

• Advocacy Groups: What resources are available to patients and their families?
• State and Federal assistance programs (financial and treatment)
• Educational programs (free)

Advocacy Groups: What resources are available to patients and their families?

The idea behind an advocacy group or organization is to provide a voice for someone(s) who is otherwise not being heard. Sometimes advocacy occurs in the form of direct patient resources; other times it takes the form of legislation work or political and social activism. Advocacy groups are made up of current and former patients, their caregivers, family members, and friends, as well as community members who take an interest in the group's cause. These groups often come from a place of being victimized by their own personal health journey and pledge an allegiance to make change for others.  

Advocacy groups and the services they offer to patients and their families vary from group to group. Not all groups are alike or offer the same resources. Some are grassroots while others have official 501(c)3 status. Some focus on serving the needs of patients within their own state, while others focus on providing education and support to a national audience. Some advocacy groups exist solely to fund research or train medical providers. All these groups exist to change the status quo for the betterment of the patient.

Direct patient resources can range from emotional and physical to financial assistance through support meetings, referrals to medical providers, and assistance to financial aid programs. Others focus on legislation, advocating for change at state and federal levels. Some groups provide community education raising awareness about tick-borne disease and prevention through local events, workshops, and conferences.

State and Federal assistance programs (financial and treatment)

Though many states offer free or reduced care programs to those that qualify, even with hardship programs in place, most of them do not cover doctors' visits or treatment for Lyme disease. There are, however, national organizations and companies that provide financial assistance for testing and treatment, again for those who qualify. The following is not a comprehensive list--please refer to individual resources for updates and applications.

LivLyme Foundation
www.livlymefoundation.org

• The LivLyme Foundation supports children (ages 0-21) and their families by awarding annual grants to help pay for their Lyme medication and doctors' visits.

Lyme Tap
http://www.lymetap.com/

• The Lyme Test Access Program is a nationwide patient assistance program that provide assistance for initial Lyme-related lab tests to patients who demonstrate true financial need.

Lyme Light
http://lymelightfoundation.org

• Lyme Light provides financial assistance to anyone diagnosed with Lyme disease between the ages of 3 and 25 and who can demonstrate financial need.

Lyme Aid 4Kids
https://lymediseaseassociation.org

• The LymeAid 4 Kids (LA4K) fund began in 2004 and has helped children throughout the United States and Canada. Developed with the help of author Amy Tan, the fund is for children who do not have or receive insurance coverage for Lyme disease treatment for children and have economic difficulties. Donations can be made online to help LA4K as there are so many applicants, the fund does run out of money frequently.

ClinicalTrials
http://clinicaltrials.gov

• ClinicalTrials.gov is a registry and results database of federally and privately supported clinical trials conducted in the United States and around the world. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations, and phone numbers for more details. This information should be used in conjunction with advice from health care professionals.

GSK for you
https://www.gskforyou.com

• GSK For You is a GlaxoSmithKline patient assistance program. It provides GSK prescription medicines-at no charge-to qualified patients who are enrolled in a Medicare Part D Prescription Drug Plan, as well as. low cost or no cost medications for non-medicare patients or people who do not have prescription coverage. It is a great program for Malarone and Mepron.

Partnership for Prescription Assistance (PPA)  
https://www.pparx.org

• The Partnership for Prescription Assistance helps qualifying patients without prescription drug coverage get the medicines they need through the program that is right for them. Co-pay programs provide financial assistance for certain health care costs to patients who qualify financially and medically.

PPA Discount Drug Card Programs
https://www.pparx.org/prescription_assistance_programs/savings_cards

• A list of many state and other "savings card" programs to help with cost of medications.

Needy Meds
https://www.needymeds.org

• This is a Patient Assistance Program (PAP). PAPs are offered by pharmaceutical companies to help those most in need gain access to their medications at no or low cost.

https://www.needymeds.org/medical-clinics

• This webpage, also part of Needy Meds, is specifically for those without insurance or who are unable to pay for a visit with a physician, NeedyMeds has compiled a nationwide list of free, low cost, and sliding scale clinics.

Patient Advocate Foundation (Co-Pay Relief)
http://www.copays.org

• The Patient Advocate Foundation (PAF) Co-Pay Relief Program (CPR) currently provides direct financial support to insured patients, including Medicare Part D beneficiaries, who must financially and medically qualify to access pharmaceutical co-payment assistance.

Prescription Hope
http://www.prescriptionhope.com/

• Prescription Hope is program that helps people get prescriptions at a much lower price.

RxAssist
http://www.rxassist.org

• Patient assistance programs are run by pharmaceutical companies to provide free medications to people who cannot afford to buy their medicine. RxAssist offers a comprehensive database of these patient assistance programs.

Rx Hope
https://www.rxhope.com

• RxHope offers a helping hand to people in need of critical medications that they would normally have trouble affording. They act as your advocate in making the patient assistance program journey easier and faster by supplying vital information and help.

Financial Assistance for Lyme Disease Patients
http://lyme.kaiserpapers.org/financial-assistance.html

Educational programs (free)

Many advocacy groups host educational events, bringing in speakers that offer expert educational presentations on diagnosis and treatment and exhibitors that offer products and services that serve the needs not only of the patient but of the community at large. Often times, these events are free to all who attend. Patients and providers can learn about cutting-edge diagnostic tools as well as testing and treatment options. They can network with medical providers to receive free advice and direction. Many state and national advocacy groups, nonprofit organizations, and associations offer educational information on their websites.

TickTracker.com, a free global app, has the largest collection of tick bite photos, rash photos, and worldwide mapping of ticks. With the data it collects, TickTracker.com will be able to see tick migration and outbreaks and help warn the public. It will also be used for scientific research. TickTracker.com is a program of the nonprofit, LivLyme Foundation.

Key Theme 3: Awareness & Education - Public & Patients

Issue #3: Public Education

• Advocacy Organizations
• Workshops
• Educational events
• Conferences
• Media coverage - what's being promoted or downplayed
• Schools

Public Education

Empowering individuals to prevent tick borne illness requires dissemination of information through many channels. Among the most obvious and accessible are schools. As aptly stated by the Bay Area Lyme Foundation, "Educators are a vital first line of defense against the spread of Lyme and other tick-borne diseases." The Bay Area Lyme Foundation website provides free access to rich, matter of fact, and up-to-date curriculum for teachers, outdoor educations, science teachers, health educators, students, and parents.

Many advocacy groups and organizations are taking tick-borne disease education to the mainstream public, hosting local community education events and conferences with speakers and exhibitors, organizing workshops for medical providers and mental health clinicians to help bring awareness of tick-borne disease update-to-date. Many of these organizations are the mouthpieces for research, sharing publicly the latest diagnostic tools and treatment options along with newly discovered strains of tick and vector-borne diseases. These groups share patient stories as well as their own in hopes of conveying the importance of prevention practices and direction on what to do if bitten by a tick. Too many medical providers buy into the wait-and-see approach when research has shown that some tick-borne diseases are transmitted in less an hour. Raising awareness with up-to-date information arms the public and allows them to make informed decisions about their health needs.

Educating the public is multi-faceted, from how to look for ticks to how to remove a tick correctly. The public needs information about what symptoms to look for, where to send ticks for testing, how and where to seek a medical provider who is knowledgeable about tick-borne diseases, the challenges associated with testing, knowing what test to ask for and what treatment options exist, and how to obtain the correct knowledge in dealing with a tick-borne disease.

In August of 2013, the Centers for Disease Control (CDC) released a press release stating that they had grossly underreported the new cases of Lyme Disease by 10-fold: their report of 30,000 new cases per year was corrected to 300,000. In this same press release, they referred to Lyme Disease as the fastest growing infectious disease. "We know that routine surveillance only gives us part of the picture, and that the true number of illnesses is much greater," said Paul Mead, M.D., M.P.H, chief of epidemiology and surveillance for CDC's Lyme disease program. "This new preliminary estimate confirms that Lyme disease is a tremendous public health problem in the United States, and clearly highlights the urgent need for prevention."

According to the CDC, children ages 5-14 are a high-risk population. Tick-borne disease curriculum is being written and integrated into many endemic states' educational plans, educating children with age appropriate material and school educators and nurses on prevention and awareness of exposure.

Educational interventions to reduce Lyme disease (LD) among at-risk school children have had little study. However, a 2016 study was published in the PMC, U.S. National Library of Medicine, National Institute of Health called "A School-Based Intervention to Increase Lyme Disease Preventive Measures Among Elementary School-Aged Children." The study found that a short in-class educational program that includes elements of the Health Belief Model (HBM), including: (1) awareness and knowledge about the disease, (2) benefits of preventive behavior, and (3) confidence in ability to perform preventive behaviors can improve knowledge, attitude, and self-reported precautionary behavior among at-risk children.

In 2008, a CDC funded Lyme Disease Prevention Curriculum program at Brigham and Women's Hospital, the open paragraph states as follows: "Lyme disease incidence continues to increase despite the growing knowledge of how to prevent it. The description of Lyme disease in 1976 and subsequent characterization of its mode of transmission, causative organism and treatment is one of the most remarkable advances in medicine in the last 25 years. Nevertheless, Lyme disease continues to grow as a public health problem. While Lyme disease affects all age groups, children have one of the highest rates. Prevention remains a challenge in this group."

Provider Education

Tick-borne disease (TBD) symptoms are often attributed to mental health conditions and may result in referrals to mental health providers. Patients experiencing TBD neuropsychiatric and cognitive symptoms may self-refer to mental health providers. While mental health professionals might provide some comfort in the face of their suffering and assist them in strengthening their ability to cope with the emotional pain, loss, changing functioning, roles and distress, psychotherapy/counseling will not result in the treatment of the underlying illness.

Education in medical causation for mental health conditions is not a standard dimension of training for non-medical mental health care providers. In a study published in the Primary Care Companion Journal of Clinical Psychiatry, it was reported that medical doctors, primary care, and psychiatrists, were three times more likely to identify underlying medical illnesses contributing to mental health symptoms, such as mood concerns, behavioral symptoms, and anxiety, than non-medically trained mental health providers. (See Appendix 4: The "Lyme-Literate Mental Health Evaluation")

Failure to identify a covert medical illness such as a tick-borne disease inadvertently contributes to the patient's delay in receiving a correct diagnosis and treatment, which can have dire consequences. Further, well-intentioned, yet uninformed clinicians may play a role in the diminished sense of agency on the part of the patient, as interventions do not result in amelioration of their symptoms.

Potential Actions

1. Provide education regarding prevention and recognition of tick-borne diseases, ticks, tick bites and how to remove a tick correctly. Audience-specific messaging and outreach. The audience includes but is not limited to the following groups: Schools (all levels), Nurses/ Clinics, Primary/Family Care Physicians, Rural Family Physicians, Emergency Room Doctors, Infectious Disease Doctors, Mental Health Professionals, Specialist Doctors, Summer Camps for kids, FireFighter, First Responders, Police, NCAA, Athletic Coaches/ Program, Park/Wildlife Employees, Hunters, Native American tribes and populations, Underserved populations, including racial minorities.
2. Have a more comprehensive and interactive website at the federal level; app/technology (e.g. TickTracker.com)
3. Federal government to include TBD curriculum in the school system, especially in endemic regions
4. Treat Lyme and other tick-borne diseases as chronic illnesses. Even without definitive or settled science determining the exact cause, there is agreement on all sides that debilitating symptoms linger for up to 20 percent of Lyme disease patients. The approach for other chronic conditions is to address and manage the medical, social, economic, and psychological challenges faced by those with chronic conditions or chronic symptoms. Lyme and tick-borne illness should be no exception.

Issue #4: Legislation

• Laws to promote patient rights
• Laws to protect physicians

Legislation

All too often, legislation for patient rights for access to adequate diagnostic and treatment options as well as protection for physicians falls upon the patients and their families. In endemic states, where providers treat the patients until they are better, these medical providers fall prey to attacks from other medical providers who feel they are compromising the health of the patient. When the Infectious Disease Society of America (IDSA) wrote their guidelines for treating Lyme Disease, they included a footnote that read as follows: "These guidelines were developed and issued on behalf of the Infectious Diseases Society of America. It is important to realize that guidelines cannot always account for individual variation among patients. They are not intended to supplant physician judgment with respect to particular patients or special clinical situations. The Infectious Diseases Society of America considers adherence to these guidelines to be voluntary, with the ultimate determination regarding their application to be made by the physician in the light of each patient's individual circumstances."

And yet, medical providers have faced disciplinary action and fines from state licensing boards because they choose to determine the direction of their patients' treatment based on individual circumstances and treatment responses. So, it falls on each state to produce legislation to promote public awareness and protection for patients and providers.

Physician protection laws afford licensed providers the right to diagnose and treat Lyme disease according to clinical criteria (MA legislation "Administration of long-term antibiotic therapy upon diagnosis of Lyme Disease").

https://malegislature.gov/Laws/GeneralLaws/PartI/TitleXVI/Chapter112/Section12DD

Lyme disease treatment coverage insurance mandates, which require insurance coverage for treatments based on clinical diagnoses and criteria, when made by licensed providers (MA Legislation "An Act Relative to the Long-term Antibiotic Therapy for the Treatment of Lyme Disease")

https://malegislature.gov/Laws/SessionLaws/Acts/2016/Chapter183

The language must be careful and precise in this legislation, to assure that it remains true to its intent. With this in mind, the following terms are defined as follows:

Long-term antibiotic therapy: The administration of oral, intramuscular or intravenous antibiotics singly or in combination, for periods of time in excess of 4 weeks, as defined by the physician protection legislation.

Lyme disease:

• The presence of signs or symptoms compatible with acute infection with Borrealia burgdorferi; or:
• Late stage, persistent or chronic infection w/B. burgdorferi; or:
• Complications related to such infection; or:
• Other strains of Borrelia that become identified or recognized

In Maine, (1) legislation was passed (LD 1709) requiring a report to be written every year for public awareness with the status of tick-borne disease surveillance and tick-borne disease case counts every year; (2) legislation was passed (LD 597) acknowledging the difficulty in diagnosing and treating Lyme Disease along with information on risk of long term antibiotic therapy; (3) legislation was passed (LD422) to improve access to treatment for Lyme Disease, allowing a medical provider to prescribe, administer, or dispense long-term antibiotic therapy to eliminate infection or control a patient's symptoms.

The following website provides a list of states that have patient and provider legislative concerning diagnosing and treating Lyme and tick-borne disease:

https://lymediseaseassociation.org/category/about-us/lda-programs-a-achievements/government/

Federal legislative efforts:

https://lymediseaseassociation.org/category/federal-legislation/

Potential Actions

1. Mandatory insurance coverage
2. Enforcement existing laws
3. Laws to protect patients' rights, including informed consent regarding the two published standards of care for Lyme disease.
4. Laws to protect physicians who wish to treat according to clinical criteria and/or ILADs guidelines.
5. Implement federal demographic reporting. Include a Lyme/Tick-borne Disease checkbox on health forms within the federal government to gather accurate date about prevalence, health impact, and cost of tick-borne diseases. Include a checkbox on medical intake forms within government healthcare institutions and programs including but not limited to: Veterans Health Administration (VHA), National Cancer Institute (NCI) Hospitals, Other NIH health facilities, Federally funded health care Centers of Excellence, Medicare, Medicaid, State Children's Health Insurance Program (SCHIP), Indian Health Service (IHS), CHAMPUS, DOD, TRICARE & others.
6. Hold Congressional hearings to gather data and correct Lyme public health and human rights issues. Legislative oversight and investigative hearings or some combination of hearings may be critical to correct the public health and human rights issues facing tick-borne disease patients: Legislative Hearingsprovide a forum where facts and opinions from witnesses and stakeholders from varied backgrounds are presented prior to considering legislation. Investigative Hearings provide a legislative remedy to address problems especially if there is a suspicion of wrongdoing on the part of public officials. Oversight Hearings review or study current law, issues and activities while focusing on the quality of federal programs. Efficiency, economy and effectiveness of government operations are scrutinized.
7. Adapting Maryland's "Patient Information Disclosure Act" as a model for legislation-notifies patient when any diagnostic test is performed that lack a high level of reliability (not necessarily restricted to Lyme testing).
8. Federal government--Extend to Medicare and ERISA law

Issue #5: Patient Education

• Recognizing that they have a tick-borne disease
• Having current information to work with
• Knowing where to find the resources in their own state

Through education and awareness about Lyme and tick-borne disease, patients and the community at large are taught the differences between tick-borne diseases, what disease certain ticks are known to carry, and how to recognize signs and symptom. Many public health offices dissemintate information about ticks and prevention but continue to share outdated information on transmission times and prophylactic dosing that continues to put the patients in harm's way. Medical providers are not known to give out information regarding support meetings and resource to their Lyme disease patients like they would a cancer or diabetes patient. Advocacy groups and organizations continue to be the front runner in sharing that information directly with patients and the public. Not all ticks are going to transmit Lyme disease (Borrelia burgdorferi), which is known to present with the classic bulls-eye rash. Educating what other tick-borne diseases exist in the area and how they present will empower a patient to recognize signs and symptoms and seek medical attention when needed.

Potential Actions

1. Add existing resources to state public health pages and Behavioral health associations
2. Use Public Service Announcements to educate people
3. Have pamphlets available at doctors' offices (tick removal, availability of tick testing, etc.) in very patient-friendly language-outline symptoms
4. Educate that patients can present with any number of symptoms and in differing intensity, advise of many different types of rashes
5. Dispel myths and promote reality, update (and keep up-to-date) information that is promoted to provider and the public

Issue #6: Provider Education

• Primary Care Physicians
• Specialty Care Physicians
• Mental Health Professionals
• Lyme Literate Workshops (peer-to-peer training)
• ILADEF
• Free Physician CME modules (See lymecme.info below - Dr. Betty Maloney)

The following is a list of organizations that offer comprehensive training programs to further a medical provider's knowledge on the complexities of diagnosing and treating Lyme and Tick-borne diseases:

International Lyme and Associated Diseases Society Educational Foundation
http://www.ilads.org/education/physician-training.php

Global Lyme Alliance
https://globallymealliance.org/education-awareness/physicians-training-program/

• Global Lyme Alliance provides CME-accredited educational programs for healthcare professionals to learn more about diagnosing and treating Lyme and other tick-borne diseases.

Partnership for Tick-borne Diseases Education (PTDE)
https://www.partnershipfortick-bornediseaseseducation.org/

• PTDE develops and makes evidence-based educational modules available to medical professionals regarding tick borne diseases for CME credits.

LymeCME
https://www.lymecme.info/

• LymeCME offers free, AAFP-accredited courses for physicians

Partnership for Healing and Health (PHH)
https://www.partnershipforhealingandhealth.com/about-us/

• PHH is a medical information company dedicated to bringing reliable scientific and medical information to the attention of the general public, employers and healthcare professionals. PHH provides accredited CME programs on Lyme disease for physicians and other health professionals as well as Lyme disease education and training programs for private organizations and government agencies.

Potential Action

1. Formal physician education on tick-borne diseases, starting in medical school and including behavioral health-associations, nurses, family nurse practitioners, Physician Assistants, Certified Nurse Assistants

Key Theme 4: Access to Affordable Medical Care

Issue #7: Federal & State Government Barriers

• Dogma
• Negative/Improper usage of CDC surveillance criteria (never intended for clinical diagnosis)
• IDSA vs ILADS:Two Standards of Care
• Guidelines vs Standards of Care
• Federal influenceson States
• Grants (facilities who rely on grants follow orders from above)
• StateLicensing Boards (physician fear of disciplinary action)

Potential Actions

1. Revert back to 2011 language on the CDC website (for language, see p. 54 of Results doc)
2. Post ILADS guidelines on CDC website
3. Draw attention to footnote on the IDSA guidelines
4. Allocate more balanced funding for Lyme and tick-borne diseases to match communication
5. Establish tick-borne disease centers of excellence (Centers of Excellence already exist to serve patients facing serious health and public health challenges ranging from autism to cancer to minority health disparities)
6. Hold a Congressional hearing about tick-borne diseases
7. Potential Action Seven: Allocate increase funding for tick-borne disease in the area of research, treatment and prevention (Highlight the disproportionate funding for Lyme vs. cancer, HIV/AIDS)
8. Protection from job discrimination due to Lyme and TBDs
9. Protection for students of all ages from discrimination due to Lyme and TBDs
10. Increase Research Funding Through Department of Defense Congressionally Directed Medical Research Program (DOD CDMRP). Research grants through the DOD CDMRP benefit both the military and civilian populations. CDMRP investigator-initiated awards for tick-borne disease research promote a wide range of research from basic through translational, including studies in animals and humans. These awards fund rigorous, high-impact studies that have the potential to significantly improve diagnosis, treatment and prevention of tick-borne diseases. [The unique structure of the DOD CDMRP allows it to be more flexible than traditional competitive peer-reviewed medical research programs. As the Institute of Medicine states in its reviews, "the program fills a unique niche among public and private funding sources." In addition, due to the program's flexibility, DOD is able to administer it with great efficiency and little bureaucracy. This means 90% of the funding goes directly to competitive peer-reviewed research grants. Finally, educated, trained consumer advocates participate in a process where research proposals are reviewed for scientific quality and program relevance, thereby engaging the public and helping to ensure transparency].

Issue #8: Insurance Blocks

• Denying services/treatment-based on IDSA criteria
• Out of Pocket expenses to patient
• Disability cost on the economy
• Lifetime cost for chronic illness (testing/treatment/support)

An obstacle to affordable care is the managed care/HMO system. The majority of doctors referred to as "Lyme-literate" are not a part of managed care systems, thus inaccessible to patients who need to obtain care within their provider group. Those who have resources to seek care outside their HMO, or who are covered by preferred provider medical insurance plans, may seek treatment from a Lyme-literate doctor. However, Lyme-literate doctors most often do not direct bill insurance companies, leaving the patient to pay for care out of pocket, sustaining higher co-pay, and submitting claims to the insurance companies for reimbursement.

Attempts to claim reimbursement for services are fraught with detours and often arrive at a dead-end, without reimbursement being received. Initial rejection of claims is common, followed by long hold times on the telephone attempting to get assistance from the insurance carrier, cumbersome documentation, and required resubmission of claims.

Obstacles presented by insurance companies include long periods of awaiting authorization for treatment and prior authorization for specialized medications not on the general formulary. This delay in treatment can have detrimental impact on the healing process of the patient.

When patients are severely ill, some with neurological issues, managing the reimbursement, claims, and appeal processes is grueling. The necessary sustained tenacity, tracking and recordkeeping, and potential additional costs are often not possible for persons who are facing a multitude of symptoms which may include neurological processing deficits and exhaustion. Without an advocate or family member to assist, patients sometimes report "giving up," feeling that they are not capable of fighting the battle for reimbursement concurrent to fighting for their health. This further contributes to their financial vulnerability and may obstruct their ability to obtain the doctor-recommended treatment.

Potential Actions

1. Insurance to cover Lyme treatment and limited Lyme testing
2. Streamline reimbursement process for patients
3. Streamline patient/doctor PA/appeal process
4. Include mental health coverage

Issue #9: Underrepresented & High-Risk Populations

• Children
• Low Income
• Mental Health patients
• Native Americans
• Military Service Members, Military Families, and Veterans
• Migrant Workers
• Pregnant Women
• Elderly

Children

Demographic data indicate that children are one of the highest risk groups for contracting tick-borne diseases. Families may be especially hard hit when more than one child is ill due to higher medical costs and time lost at work for caregiving. The stress that these children and their families experience is enormous. In addition to the need for financial resources, there is tremendous need for enlightened academic services and accommodations for children in the schools. Students with tick-borne diseases are at risk for cognitive impairments which may include visual and auditory processing disturbances, slowed processing speed, difficulty with working memory, executive functioning, and more. When the underlying infectious illness is unrecognized or poorly understood, students are at risk for misdiagnosis with a primary psychiatric disorder or learning disability, including attention deficit disorder, school or social phobia, oppositional defiant disorder, and more. These misdiagnoses overlook or ignore critical symptoms such as pain, fatigue, sleep deprivation, sensory sensitivities, processing issues and more, each of which may impair attention and impede academic progress. The unpredictable course of the illness, including day to day fluctuations in its symptoms, challenge the typical service plans in place for students with learning disabilities, or with illnesses which have a more predictable course or defined endpoint.

School field trips into Lyme-endemic areas and playgrounds place children at risk for contracting Lyme disease. Prevention and awareness measures must be implemented in these situations, including but not limited to appropriate notification and balanced information regarding risk and prevention provided to parents.

Students with Lyme disease all too often face the added burden of needing to convince the school authorities of the reality and credibility of their ongoing illness. They require flexible attendance policies without fear of truancy charges. Existing models of accommodations provided in 504 plans and IEPs often are not suited for children with TBD. Current educational systems may present the options of "attend or don't attend;" home teaching or school attendance. Hybrid and creatively designed plans are necessary to provide opportunities for the richest and most "normal" growth and development for children who are, by no fault of their own, faced with a childhood riddled with myriad symptoms which compromise their ability to fully engage in mainstream education.

Socialization is an essential part of the process of child development and a crucial element of human well-being. Punitive measures can be enforced such as disallowing students to attend after school activities if they have not attended school. As TBD symptoms wax and wane, even over the course of the day, excluding children from meaningful socialization with their peers is punishing, isolating and intensifies the emotional pain and loss for these children. Further, the longer a young person is at home and outside the peer environment, the more difficult it may be to re-enter. This isolation may result in unintended social and emotional consequences that compound the challenges the young person faces.

TBD, with all of its clinical and physiological complexity, creates a ripple effect of devastation beyond the patient's body into every arena of his or her life. In part determined by the timing of diagnosis, access to and effectiveness of treatment, and the severity of symptoms, the patient's life trajectory is severely disrupted.

Among the myriad losses is one's role in the community, school, work, and within the family. This may be true not only for the patient, but family members as well as they pull back from social activities, abandon career or school plans, eliminate hobbies and place other relationships on hold to become caregivers, advocates, case managers, educators, negotiators, researchers, transporters, record keepers, emotional supporters, spiritual guides and errand doers. Finances become strapped. Families and patients talk about selling or taking loans out against their homes, reducing the family to one car, in two-parent families one parent giving up their job or interrupting their career, and abandoning planning of all kinds as the needs and condition of the patient is unpredictable day-to- day. Other family financial priorities are set aside to pay for uncovered care.

Relationships may become strained. Spouses become caregivers. Divorces occur. Well children feel marginalized and may work to be the ideal child, become invisible, or compete for attention. Friends fall away. Isolation, which is, in and of itself, a public health issue becomes a significant contributing factor to the overall quality of life and well-being of the individual and family.

The health impact on caregivers is well documented. In 2003 a review of 23 studies involving 3,072 participants, psychologist Peter Vitaliano, PhD, and his found that care givers, compared to non-care givers had a 23 percent higher level of stress hormones and a 15 percent lower level of antibody responses than non- caregivers, thus rendering them more vulnerable to infections, increasing the risk of high blood pressure, glucose levels, hypertension and diabetes. Other studies demonstrate higher levels of depression amongst caregivers and that the immune system continues to be compromised years after the care giving has ceased, thus contributing to the onset of chronic illness in the caregivers and the resulting costs. This calls out the need for care giver support, not only to relieve their suffering, but to reduce the cost to society as a whole, precipitated by the compounding illness, job loss, loss of the ability to prepare for retirement, depletion of educational accounts- the list goes on.

Every member of a family is affected, and the family's quality of life as a whole is radically impacted. A study published in the International Journal of General Medicine reveals that the experience of chronic and life-altering illness on the family is profound, having great impact on the relationships, finances, employment, emotional well-being. Spiritual and existential distress is often an integral part of this experience, as well. It follows that the family quality of life is a dimension of health care which has been neglected and needs to be addressed to provide support for both the patient and family unit. Complicated grieving can be a result of the tremendous loss which occurs in all arenas of a person's and family's lives.

For patients with TBD, this disruption to the psychosocial aspects of the patient and family is multiplied by the societal context of controversy and confusion, in which Lyme disease occurs. Client stories replete with tales of mistreatment by disbelieving health care providers whom they once trusted, the misapplication of psychopathological diagnoses, the stigmatization of chronic Lyme as hypochondria or categorized as medically unexplained symptoms, the alienation of members of one's support system converge to create a non-supportive to hostile environment in which the patient is struggling to address severe illness and survive. As such, it is not an optimal healing environment. When combined with tremendous and widespread loss, financial and medical survival concerns, disabling and traumatizing symptoms, the result may be medical trauma and, in some cases, the development of PTSD, secondary to the societal and elements of the medical communities' response to persons with TBD. There is extensive research which demonstrates the impact of trauma and a stressed autonomic nervous system has on health and healing.

The suggestion that medical treatment can be traumatic seems antithetical to the Hippocratic Oath and our cultures' historical, deep and abiding respect and trust in medical professionals. However, TBD patients report significant and repeated experiences with medical staff which are experienced as disrespectful, confrontational, and deeply distressing. Patients talk about the stress of needing to obtain medical care from providers who do not believe them, do not see their suffering as real, and who hold the power in terms of access to medical care. This can result in symptoms of medical trauma (avoidance, anxiety, intrusive memories, intense emotions or numbing, hyper-vigilance) and impact the patient's sense of safety and optimism for treatment which can lead to improvement in their health status. Children are more vulnerable to the impact of disbelief, and parents report stress and anxiety, struggling to maintain employment and parent their other children, while advocating for services, and at the same time trying to protect their child from systems and experiences which threaten further harm. A patient whose functioning is dramatically compromised or whose choices are dictated by geography or their HMO, may not be able to simply leave one provider or institution to find another more responsive provider/system. The illness itself can prevent self-advocacy. Persons who do not have a family member or friend to assist with coordination of care, research and advocacy are severely limited in their ability to secure appropriate medical intervention, which may lead to a sense of hopelessness and desperation. Plummeting financial security and lost earning potential has resulted in homelessness for some patients.

Parents have been reported to child protective agencies; some have been accused of Munchausen Syndrome by Proxy (MSBP) and have had to defend themselves in court. Schools must adopt an enlightened, informed approach for dealing with students and their families who suffer from TBDs. This will promote a productive collaboration and avoid the adversarial relationship which might otherwise develop, enabling them to fulfill their obligation to provide a free and appropriate public education (FAPE) to students with TBDs. In terms of legal protections, 504 plans and IDEA special education law may be utilized to develop appropriate, individualized education plans (IEP's).

Mental Health Patients

Thousands of articles show a causal association between infections and mental illness, and 400 articles support the causal association between tick-borne disease and mental illness. These include but are not limited to depression, anxiety, bipolar illness, cognitive impairments and psychosis. Dr. Robert Bransfield and others have addressed the immunological, neurological, and mechanisms by which the Lyme bacteria, Borrelia burgdorferi (Bb), may cause neuropsychiatric symptoms.

Given unreliable diagnostic testing, physicians who fail to identify a medical explanation for a patient's physical symptoms may erroneously attribute them to emotional factors; in such cases, misdiagnosis with anxiety or somatization is not uncommon. Patients who experience Lyme-induced neuropsychiatric symptoms are particularly at risk for misdiagnosis with a primary psychiatric disorder. This results in inadequate medical treatment, and also adds to the patient's distress and despair. Many of these patients bounce between hospitalizations in psychiatric and medical facilities, with little appreciation of the infectious etiology of their neuropsychiatric symptomatology. This disrupts continuity of care and results in a fragmented approach to complex, multi-systemic illnesses. There is a need for dual diagnosis inpatient units equipped to treat patients with infection-induced neuropsychiatric symptoms.

Patients with neuropsychiatric symptoms also may experience an exacerbation of these symptoms as part of a Jarisch-Herxheimer or die-off reaction; these may include increased depression, suicidality, anxiety, agitation, cutting, cognitive confusion, aggressive behavior and more. Here again, is essential that practitioners understand the etiology of such symptoms, both in order to implement appropriate support services, as well as to ensure continuity of care with regard to the medical treatment.

Inadequate access to care for Lyme/tick-borne diseases has serious implications and results in fatalities, a broad spectrum of psychiatric and general medical illness, impairment, disability, presenteeism, absenteeism, lost productivity, caretaker burden economic losses and suffering.

Psychiatric fatalities area a result of suicide (1200/year in US), drug overdoses and homicides. Inadequate access to treatment for chronic psychiatric symptoms and chronic pain has contributed greatly to an epidemic of opioid and other substance abuse and deaths in this country. Access to care barriers are further compounded by pharmaceutical benefit management companies that create formularies that obstruct access to less addictive treatments and have step therapy policies favoring he use of the more addictive generic opioids and benzodiazepines which strongly influences prescribing patterns.

Other neuropsychiatric fatalities are a result of congenital Lyme infections, Lyme meningitis, symptomatic late Lyme neuroborreliosis, late Lyme neuritis or neuropathy, meningovascular and neuroborreliosis with cerebral infarcts, intracranial aneurysm, late Lyme encephalitis, late Lyme meningo-encephalitis or meningomyelo encephalitis, atrophic form of Lyme meningo- encephalitis with dementia & subacute presenile dementia. Somatic fatalities are a result of Lyme nephritis, Lyme hepatitis, Lyme aortic aneurysm, coronary artery aneurysm, late Lyme endocarditis, Lyme carditis, late Lyme disease of liver and other viscera, late Lyme disease of kidney & ureter and late Lyme disease of bronchus & lung.

Other countries often follow United States healthcare policies regarding Lyme disease. Effective polices have positive benefit on global health while flawed policies can have catastrophic effects upon access to care.

The need for a coordinated, multidisciplinary treatment team approach must include education and training for mental health professionals regarding the full spectrum of symptoms possible with Lyme disease. One effort in this regard has been an annual conference from 2010-2016, sponsored by the Lyme Connection, the Leir Charitable Trust Foundation and the Lyme Disease Association, Inc. Presenters have included Lyme disease medical specialist Kenneth Liegner, M.D., psychiatrist Robert Bransfield, M.D., neuropsychologist Judith G. Leventhal, Ph.D, clinical psychologist Sheila M. Statlender, Ph.D. and social worker Sandra Berenbaum, L.C.S.W., all of whom have had extensive experience treating patients with tick-borne disease in their practices. This group has presented a similar conference at Bryant University in Rhode Island. (See Appendix 4: The “Lyme-Literate” Mental Health Evaluation.)

In summary, patients with infection-induced neuropsychiatric symptoms are at risk for misdiagnosis with a primary psychiatric disorder. Familiarity with the full spectrum of symptoms possible with tick-borne diseases is essential in order to provide these patients with an effective, multi-systemic treatment approach which recognizes the underlying infectious etiology.

Native Americans

The federal government is obligated by law to provide medical care to American Indians and Alaska natives through the Indian Health Service (IHS), an agency of HHS. Many are considered to be low-income and dependent upon Medicaid for their healthcare. The IHS is chronically under-funded, and on reservations, HIS facilities often do not have services that people elsewhere commonly expect. Moreover, they are often hours away by from the patients who need their services by car. Those limited facilities can be hours away by car.

Military Service Members, Military Families, and Veterans

Members of the military (active duty) and their families are at a distinct disadvantage because they struggle to maintain consistency with primary care providers. Because the military is under-resourced and under-manned (across the board including medical providers), many military service members and their families do not receive consistency of care over time with the same provider. Continuity of care is vital to accurately diagnosing and adequately treating chronic Lyme and tick-borne diseases. Military medicine is well suited for acute, easy-to-diagnose illnesses, injuries, and infections. It is not well suited for chronic or complex conditions because both families and medical providers are regularly deployed and moved to different locations.

Military members, their families and by extension, our veterans are the most high-risk population due to exposure of global species and strains of tick-borne disease. In the case of veterans, they may be medically separated and/or retired people with undiagnosed or misdiagnosed diseases. Unless they hit the twenty-year pension mark, which allows them more choice in the medical providers they want to see, veterans are dependent on Veteran's Administration's healthcare. As such, they are subjected to the same federal guidelines for diagnosing and treating tick-borne illness that are being called into questions by this subcommittee.

Hispanic Populations

Hispanics compromise 43.6% of grounds maintenance workers and 43.4% of workers in farming, forestry, and fishing industries, leading to higher rates of exposure to ticks, and potentially tick-borne diseases. Compared to non-Hispanics, Hispanics displayed signs of disseminated infection and symptoms onset during the fall at a significantly higher rate. Placing this population at further risk, only 58.5% were reported as having health insurance during the 2009 to 2013 period compared to 84.9% of non-Hispanic whites. Moreover, 15.5% of Hispanics studied reported not seeking or delaying medical intervention.

Migrant Workers

Due to outdoor working habits, with limited or no healthcare, migrant workers have a high-risk exposure to tick-borne diseases without the means for adequate diagnosis and/or proper treatment.

Pregnant Women

Gestational tick-borne disease is transmitted to unborn children in utero and has the potential to cause premature labor and fetal death.

Potential Actions

1. For healthcare provision to be available across demographics
2. Educational materials in multiple languages
3. Required that entities that take federal money to provide education
4. Ob/Gyn TBD training for potential gestational transmission during pregnancy

Key Theme 5: Access to Proper Diagnosis & Treatment

Issue #10: Proper Diagnosis & Proper Treatment

• Physician knowledge
• Acute vs Post-Treatment Lyme Disorder vs Chronic
• Late stage Lyme neuro-psychiatric symptoms
• Exploitation of patients with costly and extreme treatments
• A willingness to treat until better (remission)
• Affordable and reliable diagnostic tools
• All tick-borne illness including strains and species, sensitivity and specificity across the board

Proper Diagnosis, Treatment, and Informed Consent

Chronic Lyme disease patients have significantly impaired quality of life and greater healthcare utilization compared to the general population and patients with other chronic diseases. Forty percent of those with chronic Lyme report being unable to work due to Lyme disease, and twenty-four percent of patients with chronic Lyme disease report being on disability at some point in their illness. Lyme disease patients frequently experience significant delays in diagnosis and treatment. These combined factors underscore the tremendous need for earlier diagnosis and innovative treatment approaches.

Ideally, practice guidelines enable physicians to draw on the best evidence-based medicine (EBM) to provide proper treatment. However, the guideline development process can be imperfect. A study of the guidelines of the Infectious Diseases Society of America (IDSA) found that only one in seven of their guideline recommendations was based on strong evidence. The National Guidelines Clearinghouse (NGC) lists twenty-five medical conditions with conflicting guidelines.

EBM is the integration of clinical expertise, patient values, and the best research evidence into the decision-making process for patient care. With respect to Lyme disease, however, the scientific evidence base regarding treatment is lacking. Only three NIH funded randomized controlled double-blind studies exist, and each of them utilized very small sample sizes. These studies yielded conflicting results regarding the value of extended antibiotic treatment, but two found improvement in levels of fatigue. Several observational trials do support further treatment but are discounted by the IDSA.

Under these circumstances, who decides the appropriate course of treatment for the patient? The IDSA contends that the existing evidence base is too weak to warrant intervention beyond twenty-eight days of antibiotic treatment. The International Lyme and Associated Diseases Society (ILADS), on the other hand, contends that, given the very poor quality of life for patients with Lyme disease, the evidence is strong enough to support treatment. ILADS has published Lyme disease treatment guidelines which adhere to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system as its basis for evidence assessment and the development of recommendations; this is the system recommended by the Institute of Medicine to ensure a transparent and trustworthy guideline process. These published guidelines are posted on the National Guidelines Clearinghouse.

Currently available diagnostic tests are unable to monitor treatment progress or demonstrate eradication of the disease. Even the IDSA, whose Lyme disease treatment guidelines are most frequently utilized by health insurers to determine coverage, notes that “guidelines cannot always account for individual variation among patients. They are not intended to supplant physician judgement….”

In spite of this, mainstream dogma has continued to promote a model of Lyme disease based on unreliable diagnostic testing and an arbitrary end point for antibiotic treatment.

Inappropriate use of surveillance criteria, the absence of a strong clinical definition, the presence of co-infections and health insurers utilizing problematic criteria to restrict coverage has negatively impacted proper diagnosis and treatment in the clinical setting. EBM only works when you have scientific evidence; however, lacking evidence or in light of conflicting evidence, the reliance of clinical judgement and patient values becomes all the more critical. Each of these factors has negatively impeded patient support and access to care.

The legal doctrine of informed consent requires physicians to inform patients of existing treatment options, their probable outcomes, and the risks and benefits associated with each. For a patient who may be too ill to work or to attend school, the potential benefits of treatment may well outweigh the risks. It is essential that patients be provided informed consent, together with the authority to decide which of the available treatment options they wish to follow. In keeping with this, health insurance companies must be required to provide coverage for those treatments, as has occurred through legislative action in several states, including Massachusetts, Rhode Island and California.

Potential Actions

1. Funding research to lead to accurate diagnosis and treatment of all stages
2. Better physician training – med schools, especially endemic areas
3. Include tick-borne disease education with mental health training
4. Introduce Informed Consent Form into medical visits. (See Appendix 3: Informed Consent for Treatment of Persistent Lyme Disease.)

Issue #11: Affordable treatment options

• Insurance blocks (denying services/treatment)
• Mainstream and Alternative options covered
• Long-Term Recovery & Support
• Physical & Occupational Therapy

Potential Actions

1. Update coding – currently for acute, need for chronic and co-infections
2. Expand insurance coverage for complimentary/alternative visits and treatment options (such as but not limited to PT/OT, reiki, acupuncture)

Summary of the Access to Care and Support to Patients Subcommittee Report to Working Group

In the weeks and months that we have met, we have taken all the key themes and issues identified barriers to patients accessing care services and support and summarized our priority issues that we present to you here today. We have also recognized services currently available to patients at both a state and national level. It is our hope that you will review our concerns and accept our potential action items as you move forward with your report to Congress.

Where Can We Improve?

• Provide affordable and accessible healthcare service to reduce the incidence of preventable diseases, promote early detection and diagnosis of these diseases at the stage when they are most easily treated, and reduce mortality and morbidity of chronic disease. If people cannot afford the services or if the services do not exist within a reasonable travel distance, patients will forego treatment and run the risk of chronic illness and disability. For children, this negatively impacts their academic progress and their parents may lose time at work, causing further economic hardship.
• Address educational gaps: This requires familiarity with the signs and symptoms of tick-borne disease (TBD), including both Lyme and co-infections, and knowing when to seek help, as well as information regarding the unreliability of available diagnostic testing.
• Assist with finding providers familiar with the complexity of TBD and promote legislation that will require health insurers to provide appropriate coverage for those treatments, ideally on the federal level, as several states have done already. This will alleviate the financial strain currently associated with such treatments and allow a greater number of patients to access necessary care, a factor particularly important for families with more than one family member who is ill.
• Require better physician education, which will reduce the number of physicians that many people see before being correctly diagnosed with TBD and prevent delays in treatment which lead to more chronic and disabling symptoms. This will also reduce the cost of treatment in terms of time, energy, finances and heartache.
• Promote improved public awareness and understanding of TBDs, to alleviate the isolation and despair experienced by so many patients, who often experience loss of support from family and friends unfamiliar with the complexity of the disease.

What Needs to Change?

Education has been one of our top priorities to facilitate appropriate, timely diagnosis and treatment, and to minimize the risk of chronic illness and disability.

• There is an urgent need for more accurate, affordable, and reliable testing to reduce the risk of misdiagnosis leading to chronic illness, miscarriage, disability, unexplained neuropsychiatric disease (depression, anxiety, OCD, psychosis, suicide) and even death.
• The CDC must restore the language included in 2011, which is currently omitted from the case definition posted on their website: “this surveillance case definition was developed for national reporting of Lyme disease; it is not intended to be used in clinical diagnosis.”
• Provider education must include the following statement, which appears as a footnote in the Lyme disease treatment guidelines published by the Infectious Diseases Society of America (IDSA):

It is important to realize that guidelines cannot always account for individual variation among patients. They are not intended to supplant physician judgment with respect to particular patients or special clinical situations. The Infectious Diseases Society of America considers adherence to these guidelines to be voluntary, with the ultimate determination regarding their application to be made by the physician in the light of each patient's individual circumstances.

• Given the unsettled science regarding TBD, providers must be familiar with both sets of published treatment guidelines and prepared to share that information with their patients, including the potential risks and benefits of each treatment choice. This is similar to what is currently done in the areas of breast cancer and prostate screening, and Lyme disease deserves no less. Only when providers are fully informed themselves will they be able to provide shared decision-making and true informed consent for their patients.
• The need for legislation, similar to what has been passed in several states: 1) Physician protection, which affords licensed providers the right to diagnose and treat according to clinical criteria, 2) Lyme and TBD treatment coverage insurance mandate, which require insurance coverage for treatment based on clinical diagnosis and criteria, when made by licensed providers and 3) Patient information disclosures legislation requiring that patients and providers be appraised of the limitations or unreliability of laboratory testing for Lyme and TBDs.
• Lyme disease is a complex, potentially multi-systemic illness which requires considerable time to evaluate and treat, to coordinate care with other specialists, and consult with social service agencies which may be involved. Current reimbursement practices must allow providers enough time to do this properly and receive appropriate compensation for their time and expertise. This will encourage more providers to take on the challenges of treating patients with this disease, preventing provider burnout and financial stress.

In conclusion, our subcommittee has identified barriers to access to care and patient support that lead to misdiagnosis, promote improper treatment, and contribute to the ranks of chronically ill and disabled communities. It is essential to address these barriers to care, and to extend to all TBD patients the compassion, caring and respect that they deserve.

Respectfully submitted.

Appendix 1: References by Topic

Key Theme 1: Access to Care and Support: Past

Issue #1: How did we get here?

Background

American Psychiatric Association. (2016). The American Psychiatric Association practice guidelines for the psychiatric evaluation of adults (3rd ed.). Retrieved March 3, 2017, from http://psychiatryonline.org/doi/pdf/10.1176/appi.books.9780890426760

Andrade, B. B., Teixeira, C. R., Barral, A., & Barral-Netto, M. (2005). Haematophagous arthropod saliva and host defense system: A tale of tear and blood. Annals of the Brazilian Academy of Sciences, 77(4), 665-693.

Ang, C. W., Notermans, D. W., Hommes, M., Simoons-Smit, A. M., & Herremans, T. (2011). Large differences between test strategies for the detection of anti-Borrelia antibodies are revealed by comparing eight ELISAs and five immunoblots. European Journal of Microbiology & Infectious Diseases, 30, 1027-1032. doi:10.1007/s10096-011-1157-6

Bakken, L. L., Callister, S. M., Wand, P. J., & Schell, R. F. (1997). Interlaboratory comparison of test results for detection of Lyme disease by 516 participants in the Wisconsin State Laboratory of Hygiene/College of American Pathologists Proficiency Testing Program. Journal of Clinical Microbiology, 35(3), 537-543.

Bransfield, R. C. (1996). The neuropsychiatric assessment of Lyme disease. Retrieved March 3, 2017, from http://www.mentalhealthandillness.com/lymeframes.html

Bransfield, R. C. (April 25, 1998). The neuropsychiatric assessment of Lyme disease by the primary care physician. 11th Annual International Scientific Conference on Lyme Disease & Other Spirochetal and Tick-borne Disorders: New York.

Bransfield, R. C. (2017). Suicide and Lyme and associated diseases. Neuropsychiatric Disease and Treatment, 13, 1575-1587. doi:10.2147/NDT.S136137

Bransfield, R. C. (2018a). Aggressiveness, violence, homicidality, homicide, and Lyme disease. Neuropsychiatric Disease and Treatment, 14, 693-713.

Bransfield, R. C. (April 28, 2018b). Lyme borreliosis and mental illness: Past, present and future [PowerPoint slides]. European Lyme Borreliosis Conference: Villach, Austria.

Burgdorfer, W., Barbour, A. G., Hayes, S. F., Benach, J. L., Grunwaldt, E., & Davis, J. P. (1982). Lyme disease: A tick-born spirochetosis? Science, 216(4552), 1317-1319.

Chowdri, H. M., Gugliotta, J. L., Berardi, V. P., Goethert, H. K., Molloy, P. J., Sterling, S. L., & Telford III, S. R. (2013). Borrelia miyamotoi infection presenting as human granulocytic anaplasmosis. Annals of Internal Medicine, 159, 21-27.

Clark, K. L., Leydet, B., & Hartman, S. (2013). Lyme Borreliosis in human patients in Florida and Georgia, USA. International Journal of Medical Sciences, 10(7), 915-931. doi:10.7150/ijms.6273

Clark, K. L., Leydet, B. F., & Threlkeld, C. (2014). Geographical and genospecies distribution of Borrelia burgdorferi sensu lato DNA detected in humans in the USA. Journal of Medical Microbiology, 63, 674-684. doi:10.1099/jmm.0.073122-0

Conant, J. L., Powers, J., Sharp, G., Mead, P. S., & Nelson, C. A. (2018). Lyme Disease Testing in a High-Incidence State: Clinician Knowledge and Patterns. American Journal of Clinical Pathology, 149(3):234-240. doi:10.1093/ajcp/aqx153

Frost, A. (2016). A grounded theory exploration of knowing: Beginning with the reality of the lyme body (Doctoral dissertation). Gonzaga University, Spokane, WA.

Girard, Y. A., Fedorova, N., & Lane, R. S. (2011). Genetic diversity of Borrelia burgdorferi and detection of B. bissettii-like DNA in serum of north-coastal California residents. Journal of Clinical Microbiology, 49(3), 945-954. doi:10.1128/JCM.01689-10

Hamlen, R. A., & Kliman, D. S. (2007). Lyme disease: Etiology, neuropsychological sequelae, and educational impact. Newspaper of the National Association of School Psychologists, 35(5), 34-36.

Hersh, M. H., Ostfeld, R. S., McHenry, D. J., Tibbetts, M., Brunner, J. L., Killilea, M. E., . . . Keesing, F. (2014). Co-infection of blacklegged ticks with Babesia microti and Borrelia burgdorferi is higher than expected and acquired from small mammal hosts. PLoS One, 9(6), 1-8.

Horowitz, R. I. (2013). Why can’t I get better? Solving the mystery of Lyme & chronic disease. New York: St. Martin’s Press.

Johnson, L., Aylward, A., & Stricker, R. B. (2011). Healthcare access and burden of care for patients with Lyme disease: A large United States survey. Health Policy, 102, 64-71.

Johnson, L., & Stricker, R. B. (2010a). Final report of the Lyme disease review panel of the Infectious Diseases Society of America: A pyrrhic victory? Clinical Infectious Diseases, 51(9), 1108-1009. doi:10.1086/656690

Johnson, L., Wilcox, S., Mankoff, J., & Stricker, R. B. (2014). Severity of chronic lyme disease compared to other chronic conditions: A quality of life survey. PeerJ, 2(e322), 1-21. doi:10.7717/peerj.322

doi:10.1016/j.healthpol.2011.05.007

Keller, A., Graefen, A., Ball, M., Matzas, M., Boisguerin, V., Maixner, F., . . . Zink, A. (2012). New insights into the Tyrolean Iceman’s origin and phenotype as inferred by whole-genome sequencing. Nature Communications, 3(698), 1-9. doi:10.1038/ncomms1701

Luger, S. W., & Krauss, E. (1990). Serologic tests for Lyme disease. Archives of Internal Medicine, 150, 761-763.

Murray, P. (1996). The widening circle: A Lyme disease pioneer tells her story. New York: St. Martin’s Press.

Poinar, Jr., G. (2014). Spirochete-like cells in a Dominican amber Ambylomma tick (Arachnida: Ixodidae). Historical Biology, 26, 1-6. doi:10.1080/08912963.2014.897699

Rister, R. (2015). New tick-borne infection similar to Lyme disease appears in US and UK. SteadyHealth. Retrieved April 29, 2018, from https://www.steadyhealth.com

Sokolowski, R. (2000). Introduction to phenomenology. Cambridge, NY: Cambridge University Press.

Spielman, A., Telford III, S. R., & Pollack, R. J. (1993). The origins and course of the present outbreak of Lyme disease. In H. S. Ginsberg (Ed.), Ecology and environmental management of Lyme disease (pp. 83-96). New Brunswick, NJ: Rutgers University Press.

Statlender, S. (October 21, 2016). The brain and behavior in tick-borne diseases: Diagnostic challenges for mental health practitioners. Infectious Causes of Mental Illness: The Impact of Infections on the Brain: Ridgefield, CT.

Stricker, R. B., & Lautin, A. (2003). The Lyme wars: Time to listen. Expert Opinion on Investigational Drugs, 12(10), 1609-1614.

Stricker, R. B., Lautin, A., & Burrascano, J. J. (2006). Lyme disease: The quest for magic bullets. Chemotherapy, 52, 53-59. doi:10.1159/000091726

Weintraub, P. (2013). Cure unknown: Inside the Lyme epidemic (Rev. ed.). New York: St. Martin’s Press.

Wormser, G. P., Dattwyler, R. J., Shapiro, E. D., Halperin, J. J., Steere, A. C., Klempner, M. S., . . . Nadelman, R. B. (2006). The clinical assessment, treatment, and prevention of Lyme disease, human granulocytic anaplasmosis, babesiosis: Clinical practice guidelines by the Infectious Diseases Society of America. Clinical Infectious Diseases, 43(9), 1089-1134. doi:10.1086/508667

Zhang, X., Martin, M. I., Peña, C. A., Hopkins, A. B., Wroth, L., & Fix, A. D. (2006). Economic impact of Lyme disease. Emerging Infectious Diseases, 12(4), 653-660.

Key Theme 2: Access to Care and Patient Support - Present

Issue #2: What is the current state of access to care and which supports are available to patients & families?

Key Theme 3: Awareness & Education - Public & Patients

Issue #3: Public Education

Public Education

www.bayarealyme.org/educators/school-administrators/

https://www.cdc.gov/media/releases/2013/p0819-lyme-disease.html

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4960477/

http://www.bwhpreventlyme.org/wp-content/uploads/2008/05/curriculumfinalversion5-12-08.pdf

Other relevant articles:

https://globallymealliance.org/education-awareness/curriculum-educational-activities/

http://www.maine.gov/dhhs/mecdc/infectious-disease/epi/school-curriculum/index.shtml

https://www.cdph.ca.gov/Programs/CID/DCDC/CDPH%20Document%20Library/DLTTBCurriculumGu%20ide.pdf%20module.lymediseaseassociation.org/School_Curriculum_Order_Form.doc

http://www.newburyport.k12.ma.us/District/Departments/Health-Services/Teacher-Resources/Lyme-andTick-Borne-Diseases-for-Teachers/index.html

Issue #3: Public Education

Legislation

http://www.mldse.org/p/legislation.html

Key Theme 4: Access to Affordable Medical Care

Issue #7: Federal & State Government Barriers

Adrion, E. R., Aucott, J., Lemke, K. W., & Weiner, J. P. (2015). Health care costs, utilization and patterns of care following Lyme disease. PLoS One, 10(2), 1-14. doi:10/1371/journal.pone.0116767

Center for Telehealth and e-Health Law. (n.d.a). Physician licensure [Website]. Retrieved September 8, 2015, from http://ctel.org/

Center for Telehealth and e-Health Law. (n.d.b). Reimbursement [Website]. Retrieved September 8, 2015, from http://ctel.org/

Centers for Disease Control and Prevention. (n.d.a). FY 2014 operating plan. Retrieved December 9, 2014, from http://www.cdc.gov/fmo/topic/Budget%20Information/appropriations_budget_form_pdf/FY2014_CDC_Operating_Plan.pdf

Centers for Disease Control and Prevention. (n.d.b). FY 2017 operating plan. Retrieved April 23, 2018, from https://www.cdc.gov/budget/documents/fy2017/fy-2017-cdc-operating-plan.pdf

Harris, E., & Younggren, J. N. (2011). Risk management in the digital world. Professional Psychology: Research and Practice, 42(6), 412-418. doi:10.1037/a0025139

Johnson, L., Aylward, A., & Stricker, R. B. (2011). Healthcare access and burden of care for patients with Lyme disease: A large United States survey. Health Policy, 102, 64-71. doi:10.1016/j.healthpol.2011.05.007

Johnson, L., & Stricker, R. B. (2010). The Infectious Diseases Society of America Lyme guidelines: A cautionary tale about the development of clinical practice guidelines. Philosophy, Ethics, and Humanities in Medicine, 5(9), 1-17. doi:10.1186/1747-5341-5-9

Johnson, L., Wilcox, S., Mankoff, J., & Stricker, R. B. (2014). Severity of chronic Lyme disease compared to other chronic conditions: A quality of life survey. PeerJ, 2(e322), 1-21. doi:10.7717/peerj.322

Johnson, M., & Feder, Jr., H. M. (2010). Chronic Lyme disease: A survey of Connecticut primary care physicians. The Journal of Pediatrics, 157, 1025-1029. doi:10.1016/j.jpeds.2010.06.031

Maloney, E. L. (2011). The management of Ixodes scapularis bites in the Upper Midwest. Wisconsin Medical Journal, 110(2), 78-85.

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention. (2011). HIV surveillance report (Vol. 23). Retrieved from http://www.cdc.gov/

Seaver, J. (2015, March 24). Please help Lyme doctor Yang in San Diego who is being targeted [Web log post].Jenna’s Lyme Blog. Retrieved from http://lymediseaseresource.com/

U.S. Senate, Committee on Labor and Human Resources. (1993, August 5). Lyme disease: A diagnostic and treatment dilemma (S. Hrg. 103-265). Washington, D.C.: U.S. Government Printing Office.

U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. (2014, September 2). Breast cancer statistics [Website]. Retrieved November 12, 2014, from http://www.cdc.gov/cancer/breast/statistics/

Under Our Skin. (n.d.) The doctor is in: An important update on Dr. Joseph Jemsek [Web log post]. Author. Retrieved August 31, 2015, from http://underourskin.com/

Zhang, X., Martin, M. I., Peña, C. A., Hopkins, A. B., Wroth, L., & Fix, A. D. (2006). Economic impact of Lyme disease. Emerging Infectious Diseases, 12(4), 653-660.

Issue #9: Underrepresented & High-Risk Populations

Children

Bloom, B.J., Wyckoff, P.M., Meissner, H.C., & Steere, A.C. Neurocognitive abnormalities in children after classic manifestations of Lyme disease. Pediatric Infectious Disease Journal, 17, 1998, pp. 189-196.

Hamlen, R. & Kliman, D. Lyme disease: Etiology, neuropsychological sequelae and educational impact. Pediatric School Psychology Communique. Volume 36: No. 5, February, 2007, pp. 34-35.

Leventhal, Judith. Infection-induced neurocognitive impairments: The neuropsychological evaluation. Presented as part of "Infectious Causes of Mental Illness: The Impact of Infections on the Brain." Lear Retreat Center, Ridgefield, CT., October 21, 2016. Sponsored by Lyme Connection, the Leir Charitable Foundation and the Lyme Disease Association, Inc.

McAuliffe, P., Brassard, M., & Fallon, B. Memory and executive functions in adolescents with post-treatment Lyme disease. Applied Neuropsychology, 15: 208-219, 2008.

Tager. F.A., Fallon, B.A., Keilp, J.,Rissenberg, M., Jones, C.R. & Liebowitz, M. A controlled study of cognitive deficits in children with Lyme disease. Journal of Neuropsychiatry and Clinical Neurosciences, 2001, 13, 500-507.

Weintraub, P. Munchausen: Unusual Suspects. Psychology Today, September 1, 2007.

Mental Health Patients

Bransfield, R. “Lyme Borreliosis and Mental Illness: Past, Present and Future.” Presentation to the European Lyme Borreliosis Conference, International Conference of the Germans Borreliosis-Society.

Bransfield, R. Lyme disease, tick-borne diseases and neuropsychiatric disorders. Psychiatric Times: Special Report – Comorbidity. December, 2007.

Bransfield, R. Aggressiveness, violence, homicidality, homicide, and Lyme disease. Neuropsychiatric disease and treatment. Dove Press 2018:14.

Fallon, B. & Nields, J. Lyme disease: a neuropsychiatric illness. Am J Psychiatry 151:11, November, 1994, pp. 1571-1580.

Statlender, S. The Brain and Behavior in Tick-Born Diseases: Diagnostic Challenges for Mental Health Practitioners. Presented as part of "Infectious Causes of Mental Illness: The Impact of Infections on the Brain." Lear Retreat Center, Ridgefield, CT., October 21, 2016. Sponsored by Lyme Connection, the Leir Charitable Foundation and the Lyme Disease Association, Inc.

Weintraub, P. Emerging diseases: An infection can change your personality – there’s plenty of proof. March 30, 2009.  Retrieved from https://www.psychologytoday.com/us/blog/emerging-diseases/200903/infection-can-change-your-personality-theres-plenty-proof.

Native Americans

NPR article from April 13, 2016 “For Native Americans, Healthcare is a long, hard road away”, Misha Friedman, author

References on Neuropsychiatric Lyme:

Hajek et al. Am J Psychiatry 2002; 159:297-30 I

Caliendo et al. Psychosomatics 1995;36:69-74

Fallon BA, et al. Am J Psychiatry. 1994 Nov;151(11):1571-83.

Hook S, et al. Presented at the 13th International Conference on Lyme Borreliosis and other Tick-Borne Diseases, Boston, MA, August 19, 2013.

Bakker LL, et al. J. Clin Microbiol. 1997 537-543.

Fallon BA. Challenges in the Care of the Patient with Neuropsychiatric Lyme Disease at New Jersey Psychiatric Association Annual Conference: Challenges to Cure and Care. Iselin, NJ. March 31, 2012.

Aguero-Rosenfeld ME. Lyme disease: laboratory issues. Infect Dis Clin N Am (2008) 22:354: 301-13.

Lyme disease—United States, 2003-2005. MMWR Morb Mortal Wkly Rep. Jun 15 2007;56(23):573-576.

Cameron, Expert Review of Anti-infective therapy doi:10.1586 /14787210.2014.940900

Military Service Members, Military Families, and Veterans

http://www/chicagotribune.com/lifestyles/health/sc-military-care-health-1104-20151102-story.html

The Geographical Distribution of Incident Lyme Disease Among Active Component Service Members Stationed in the Continental United States, 2004-2013 [May 2014, Vol 21, No 5, MSMR, Authors: Lee Hurt, DrPH, MS and Kerri A, Dorsey MPH]

Vector-borne Infectious Diseases in Afghanistan, Dr Michael K. Faulde [https://www.acq.osd.mil/eie/afpmb/docs/dveps/Afghanistan.pdf]

Hispanic Populations

Schwartz BS, Goldstein MD. Lyme disease in outdoor workers: risk factors, preventive measures, and tick removal methods. Am J Epidemiol. 1990;131:877–85 .PubMed

Smith PF, Benach JL, White DJ, Stroup DF, Morse DL. Occupational risk of Lyme disease in endemic areas of New York state. Ann N Y Acad Sci. 1988;539:289–301. DOIPubMed

US Department of Labor, Bureau of Labor Statistics. Labor force statistics from the current population study—employed persons by detailed occupation, sex, race, and Hispanic or Latino ethnicity [cited 2015 Oct 27]. http://www.bls.gov/cps/cpsaat11.pdf

US Census Bureau. The Hispanic population: 2010. 2011 [cited 2015 Oct 27]. http://www.census.gov/prod/cen2010/briefs/c2010br-04.pdf

US Census Bureau. 2010 Census demographic profile summary file. 2011 [cited 2015 Oct 27]. http://www.census.gov/2010census/data

Dominguez K, Penman-Aguilar A, Chang MH, Moonesinghe R, Castellanos T, Rodriguez-Lainz A, Vital signs: leading causes of death, prevalence of diseases and risk factors, and use of health services among Hispanics in the United States—2009–2013. MMWR Morb Mortal Wkly Rep. 2015;64:469–78 .PubMed

Pew Hispanic Center. US-born Hispanics increasingly drive population developments [cited 2015 Nov 9]. http://www.pewhispanic.org/files/2011/10/2.pdf

Centers for Disease Control and Prevention. Lyme disease communications tool kit [cited 2015 Oct 27]. http://www.cdc.gov/lyme/toolkit/index.html

Connecticut Department of Public Health. Hoja informativa de la enfermedad de Lyme [cited 2015 Oct 27]. http://www.ct.gov/dph/cwp/view.asp?a=3136&q=400692

References on Health Impact of Caring on the Care Giver:

Arno, P. S. (2002, February 24). Economic value of informal caregiving: 2000. Presented at the American Association for Geriatric Psychiatry, Orlando, Fla. Available: http://www.thefamilycaregiver.org/pdfs/pa2000.ppt#1.

Cannuscio, C.C., Jones, C., Kawachi, I., Colditz, G. A., Berkman, L., & Rimm, E. (2002). Reverberation of family illness: a longitudinal assessment of informal caregiver and mental health status in the nurses' health study. American Journal of Public Health, 92, 305-1311.

Kiecolt-Glaser, J., & Glaser, R. (2003, June 30). Chronic stress and age-related increases in the proinflammatory cytokine IL-6. Proceedings of the National Academy of Sciences, 100, 9090-9095.

Schulz, R., & Beach, S. R. (1999, December 15). Caregiving as a risk factor for mortality: the caregiver health effects study. Journal of the American Medical Association, 282(23).

Vitaliano, P. P., Scanlan, J. M., & Zhang, J. (2003). Is caregiving hazardous to one's physical health? A meta-analysis. Psychological Bulletin, 129(6), 946-972.

References on Lyme and Suicide

Depressive Symptoms and Suicidal Ideation Among Symptomatic Patients With a History of Lyme Disease vs Two Comparison Groups

http://www.psychosomaticsjournal.com/article/S0033-3182(18)30131-2/fulltext

YouTube video showing Dr. Bransfield speaking on Lyme and suicide:

https://www.youtube.com/watch?v=ooTXkkO8IvU&sns=em

Chronic Illness and Suicide Risk: What Contributes to Resilience?

https://www.psychologytoday.com/us/blog/promoting-hope-preventing-suicide/201208/chronic-illness-and-suicide-risk

Lyme Disease and Suicide, An Ignored Problem - CNN iReport

http://ireport.cnn.com/docs/DOC-1037462

Robert C. Bransfield:

"Lyme, Depression, and Suicide”

www.mentalhealthandillness.com/.../LymeDepressionAndSuicide.htm

Bransfield, RC. Suicide and Lyme and associated diseases. Neuropsychiatr Dis Treat. 2017;13:1575-1587

Cameron, D. Suicidal behaviors in patients with Lyme and associated behaviors.

http://danielcameronmd.com/suicidal-behaviors-patients-Lyme-associated-diseases/

References on cost of Lyme to society

The Allocation of Time and Risk of Lyme: A Case of Ecosystem Service Income and Substitution Effects. Kevin Berry, Jude BayhamSpencer, R. Meyer, Eli P. Fenichel

“Risk of Lyme disease costs United States billions.” Amy Wallace, April 17, 2017.

https://www.upi.com/Health_News/2017/04/17/Risk-of-Lyme-disease-costs-United-States-billions/7561492440491/

Key Theme 5: Access To Proper Diagnosis & Treatment

Issue #10: Proper Diagnosis & Proper Treatment

Johnson L, Wilcox S, Mankoff J, Stricker RB. (2014) Severity of chronic Lyme disease compared to other chronic conditions: a quality of life survey. PeerJ 2:e322 https://doi.org/10.7717/peerj.322

Johnson L, Wilcox S, Mankoff J, Stricker RB. Severity of chronic Lyme disease compared to other chronic conditions: A quality of life Survey. PeerJ. 2014.

Fallon, BA, Keilp, JG, Corbera, KM, Petkova, E, Britton, CB, Dwyer, E., Slavov, I, Cheng, J, Dobkin, J, Nelson, DR, Sackeim, HA. A randomized, placebo-controlled trial of repeated IV antibiotic therapy for Lyme encephalopathy. 2008; 70(13); 992-1003 (Epub 10/2007). Neurology 2008;70: 992-1003.

Aucott, J., Crowder, L. and Kortte, K. Post-treatment Lyme disease syndrome symptomatology and the impact on life functioning: is there something here? Qual Life Res. 2013 Feb; 22(1): 75–84. Published online 2012 Feb 1. doi: 10.1007/s11136-012-0126-6

Cameron DJ. Consequences of treatment delay in Lyme disease. J Eval Clin Pract 2007;13(3):470-2

Sanghavi, D., M.D. Plenty of Guidelines, but Where's the Evidence? December 8, 2008

http://www.nytimes.com/2008/12/09/health/views/09essa.html?ref=science

Joelving F. Medical "best practice" often no more than opinion. Rueters. 2011. http://mobile.reuters.com/article/healthNews/idUSTRE70A06J20110111.

Shaneyfelt T. In Guidelines We Cannot Trust: Comment on "Failure of Clinical Practice Guidelines to Meet Institute of Medicine Standards". Archives of internal medicine. Oct 22 2012:1-2.

Coates V of National Guidelines Clearinghouse NGC/ECRI Institute. Challenges for CPG Developers and Users. Presentation before IOM Committee on Standards for Developing Trustworthy Clinical Practice Guidelines. Washington, DC. January 11, 2010.

Krupp LB, Hyman LG, Grimson R, et al. Study and treatment of post Lyme disease (STOP-LD): a randomized double masked clinical trial. Neurology. Jun 24 2003;60(12):1923-1930.

Klempner M, Hu L, Evans J, et al. Two controlled trials of antibiotic treatment in patients with persistent symptoms and a history of Lyme disease. The New England journal of medicine. 2001:85-92.

Cameron DJ. Proof that chronic lyme disease exists. Interdiscip Perspect Infect Dis.2010;2010:876450. 10. Donta S. Tetracycline therapy for chronic Lyme disease. Clin Infect Dis. Jul 1997;25 Suppl 1:S52-56.

Oksi J, Marjamaki M, Nikoskelainen J, Viljanen MK. Borrelia burgdorferi detected by culture and PCR in clinical relapse of disseminated Lyme borreliosis. Ann Med. Jun 1999;31(3):225-232.

Oksi J, Nikoskelainen J, Viljanen MK. Comparison of oral cefixime and intravenous ceftriaxone followed by oral amoxicillin in disseminated Lyme borreliosis. Eur J Clin Microbiol Infect Dis. Oct 1998;17(10):715-719.

Stricker RB, Delong AK, Green CL, Savely VR, Chamallas SN, Johnson L. Benefit of intravenous antibiotic therapy in patients referred for treatment of neurologic Lyme disease. Int J Gen Med. 2011;4:639-646.

Stricker RB, Green CL, Savely VR, Chamallas SN, Johnson L. Safety of intravenous antibiotic therapy in patients referred for treatment of neurologic Lyme disease. Minerva Med. Feb 2010;101(1):1-7.

Wahlberg P, Granlund H, Nyman D, Panelius J, Seppala I. Treatment of late Lyme borreliosis. J Infect. Nov 1994;29(3):255-261.

Johnson, L.“The Lyme Wars: Guidelines, Controversy, and Informed Consent, Medical Legal Perspectives.April, 2014).

Wormser GP, Dattwyler RJ, Shapiro ED, et al. The clinical assessment, treatment, and prevention of lyme disease, human granulocytic anaplasmosis, and babesiosis: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis 2006;43(9):1089-134

Wormser GP, Dattwyler RJ, Shapiro ED, et al. The clinical assessment, treatment, and prevention of lyme disease, human granulocytic anaplasmosis, and babesiosis: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis 2006;43(9):1089-134

Cameron DJ1, Johnson LB, Maloney EL. Evidence assessments and guideline recommendations in Lyme disease: the clinical management of known tick bites, erythema migrans rashes and persistent disease. Expert Rev Anti Infect Ther. 2014 Sep;12(9):1103-35. doi: 10.1586/14787210.2014.940900. Epub 2014 Jul 30.

Johnson, L.“The Lyme Wars: Guidelines, Controversy, and Informed Consent, Medical Legal Perspectives.April, 2014).

References on Treatment Guideline Development and Evidence-Based Medicine:

Clinical Evidence. What conclusions has Clinical Evidence drawn about what works, what doesn't based on randomised controlled trial evidence? http://clinicalevidence.bmj.com/x/set/static/cms/efficacy-categorisations.html.

Joelving F. Medical "best practice" often no more than opinion. Rueters. 2011. http://mobile.reuters.com/article/healthNews/idUSTRE70A06J20110111.

Shaneyfelt T. In Guidelines We Cannot Trust: Comment on "Failure of Clinical Practice Guidelines to Meet Institute of Medicine Standards". Archives of internal medicine. Oct 22 2012:1-2.

Institute of Medicine. Clinical Practice Guidelines We Can Trust. Washington, DC: National Academies Press; 2011.

Coates V of National Guidelines Clearinghouse NGC/ECRI Institute. Challenges for CPG Developers and Users. Presentation before IOM Committee on Standards for Developing Trustworthy Clinical Practice Guidelines. Washington, DC. January 11, 2010.

Sackett D, Straus S, Richardson W, et al. Evidence-based medicine: how to practice and teach EBM. Churchill Livingstone; Edinburgh, London: 2000.

Shaneyfelt TM, Centor RM. Reassessment of clinical practice guidelines: go gently into that good night. Jama, 301(8), 868-869 (2009).

Ioannidis, J. Evidence-based medicine has been hijacked: a report to David Sackett. Science Direct, 2016

https://www.sciencedirect.com/science/article/pii/S0895435616001475

Adamson, J., Ben-Shlomo, Y., Chaturvedi, N., & Donovan, J. (2003). Ethnicity, socio-economic position and gender—do they affect reported health—care seeking behaviour? Social Science & Medicine, 57, 895-904.

Adekoya, N. (2005). Racial disparities in nationally notifiable diseases – United States, 2002. Morbidity and Mortality Weekly Report, 54(1), 9-11.

American Academy of Environmental Medicine (n.d.). What is environmental medicine? [Website]. Retrieved September 5, 2015, from https://www.aaemonline.org/introduction.php

Anderson, J. F., & Magnarelli, L. A. (1984). Avian and mammalian hosts for spirochete-infected ticks and insects in a Lyme disease focus in Connecticut. The Yale Journal of Biology and Medicine, 57, 627-641.

Anderson, J. F., & Magnarelli, L. A. (1993). Natural history of Borrelia burgdorferi in vectors and vertebrate hosts. In H. S. Ginsberg (Ed.), Ecology and environmental management of Lyme disease (pp. 11-24). New Brunswick, NJ: Rutgers University Press.

Andrade, B. B., Teixeira, C. R., Barral, A., & Barral-Netto, M. (2005). Haematophagous arthropod saliva and host defense system: A tale of tear and blood. Annals of the Brazilian Academy of Sciences, 77(4), 665-693.

Ang, C. W., Notermans, D. W., Hommes, M., Simoons-Smit, A. M., & Herremans, T. (2011). Large differences between test strategies for the detection of anti-Borrelia antibodies are revealed by comparing eight ELISAs and five immunoblots. European Journal of Microbiology & Infectious Diseases, 30, 1027-1032. doi:10.1007/s10096-011-1157-6

Aronowitz, R. A. (1991). Lyme disease: The social construction of a new disease and its social consequences. The Milbank Quarterly, 69(1), 79-112.

Aronowitz, R. (2011). The social construction and human face of tick-borne disease. In L. J. King (Chair), Critical needs and gaps in understanding prevention, amelioration, and resolution of Lyme and other tick-borne diseases: The short-term and long-term outcomes (pp. 3.1-3.10). Washington, D.C.: The National Academies Press. Retrieved from http://www.iom.edu/

Asch, E. S., Bujak, D. I., Weiss, M., Peterson, M. G. E., & Weinstein, A. (1994). Lyme disease: An infectious and postinfectious syndrome. The Journal of Rheumatology, 21(3), 454-461.

Aucott, J. N., Crowder, L. A., Yedlin, V., & Kortte, K. B. (2012). Bull’s-eye and nontarget skin lesions of Lyme disease: An Internet survey of identification of Erythema migrans. Dermatology Research and Practice, 2012, 1-6. doi:10.1155/2012/451727

Aucott, J. N., Seifter, A., & Rebman, A. W. (2012). Probable late Lyme disease: A variant manifestation of untreated Borrelia burgdorferi infection. BMC Infectious Diseases, 12(173), 1-10. doi:10.1186/1471-2334-12-173

Auwaerter, P. G. (2007). Point: Antibiotic therapy is not the answer for patients with persisting symptoms attributable to Lyme disease. Clinical Infectious Diseases, 45, 143-148. doi:10.1086/518854

Bakken, L. L., Callister, S. M., Wand, P. J., & Schell, R. F. (1997). Interlaboratory comparison of test results for detection of Lyme disease by 516 participants in the Wisconsin State Laboratory of Hygiene/College of American Pathologists Proficiency Testing Program. Journal of Clinical Microbiology, 35(3), 537-543.

Barad, K. (2007). Meeting the universe halfway: Quantum physics and the entanglement of matter and meaning. Durham, NC: Duke University Press.

Brisson, D., Dykhuizen, D. E., & Ostfeld, R. S. (2007). Conspicuous impacts of inconspicuous hosts on the Lyme disease epidemic. Proceedings of the Royal Society, 275, 227-235. doi:10.1098/rspb.2007.1208

Brownstein, J. S., Holford, T. R., & Fish, D. (2003). A climate-based model predicts the spatial distribution of the Lyme disease vector Ixodes scapularis in the United States. Environmental Health Perspectives, 111(9), 1152-1157.

Brownstein, J. S., Skelly, D. K., Holford, T. R., & Fish, D. (2005). Forest fragmentation predicts local scale heterogeneity of Lyme disease risk. Oecologia, 146, 469-475. doi:10.1007/s00442-005-0251-9

Brunner, J. L., & Ostfeld, R. S. (2008). Multiple causes of variable tick burdens on small-mammal hosts. Ecology, 89(8), 2259-2272.

Business Wire. (2015, October 9). FDA approves Optune in combination with temozolomide for the treatment of newly diagnosed glioblastoma. Retrieved from http://www.businesswire.com/

Burgdorfer, W., Barbour, A. G., Hayes, S. F., Benach, J. L., Grunwaldt, E., & Davis, J. P. (1982). Lyme disease: A tick-born spirochetosis? Science, 216(4552), 1317-1319.

Burnet, M., & White, D. O. (1972). Natural history of infectious disease (4th ed.). Cambridge, UK: Cambridge University Press.

Burrascano, Jr., J. J. (2008). Advanced topics in Lyme disease: Diagnostic hints and treatment guidelines for Lyme and other tick borne illnesses (16th ed.). Retrieved April 18, 2014, from www.Lymenet.org/BurrGuide200810.pdf

Cameron, D. J., Johnson, L. B., & Maloney, E. L. (2014). Evidence assessments and guideline recommendations in Lyme disease: The clinical management of known tick bites, erythema migrans rashes and persistent disease. Expert Review of Anti-Infective Therapy, 12(9), 1103-1135. doi:10.1586/14787210.2014.940900

Centers for Disease Control and Prevention and US Environmental Protection Agency (2013, March). Report on tick-borne disease and integrated pest management conference. Arlington, VA: Author.

Chevalier, M. S., Chung, W., Smith, J., Weil, L. M., Hughes, S. M., Joyner, S. N., . . . Lakey, D. L. (2014). Ebola virus disease cluster in the United States – Dallas County, Texas, 2014. Morbidity and Mortality Weekly Report, 63, 1-3. Retrieved from http://www.cdc.gov/mmwr/pdf/wk/mm63e1114a5.pdf

Chowdri, H. M., Gugliotta, J. L., Berardi, V. P., Goethert, H. K., Molloy, P. J., Sterling, S. L., & Telford III, S. R. (2013). Borrelia miyamotoi infection presenting as human granulocytic anaplasmosis. Annals of Internal Medicine, 159, 21-27.

Clark, K. L., Leydet, B., & Hartman, S. (2013). Lyme Borreliosis in human patients in Florida and Georgia, USA. International Journal of Medical Sciences, 10(7), 915-931. doi:10.7150/ijms.6273

Clark, K. L., Leydet, B. F., & Threlkeld, C. (2014). Geographical and genospecies distribution of Borrelia burgdorferi sensu lato DNA detected in humans in the USA. Journal of Medical Microbiology, 63, 674-684. doi:10.1099/jmm.0.073122-0

Corapi, K. M., Gupta, S., & Liang, M. H. (2008). Management of Lyme disease. Expert Review of Anti-Infective Therapy, 6(2), 241-250. doi:10.1016/j.jpeds.2010.06.031

Crowder, L. A., Rebman, A., Yedlin, V., Soloski, M., & Aucott, J. N. (2012). Improving global health equity for infectious diseases. International Conference on Emerging Infectious Diseases Programs and Abstracts Book. Retrieved February 23, 2014, from http://www.iceid.org/images/iceid_2012_finalprogram_final.pdf

Dennis, D. T., Nekomoto, T. S., Victor, J. C., Paul, W. S., & Piesman, J. (1998). Reported distribution of Ixodes scapularis and Ixodes pacificus (Acari: Ixodidae) in the United States. Journal of Medical Entomology, 35(5), 629-638.

Division of Vector-Borne Diseases, Centers for Disease Control and Prevention. (2014, April 7). About the Division of Vector-Borne Diseases. Retrieved May 1, 2014, from http://www.cdc.gov/ncezid/dvbd/

Eisen, R. J., Eisen, L., & Beard, C. B. (2016). County-scale distribution of Ixodes scapularis and Ixodes pacificus (Acari: Ixodidae) in the continental United States. Journal of Entomology, 53(2), 1-38. doi:10.1093/jme/tjv237

Elsner, R. A., Barthold, S. W., & Baumgarth, N. (2013). The immune system cannot generate immunological memory during infection with the Lyme disease agent B. burgdorfer. Cytokine, 63 (3), 261. doi:10.1016/j.cyto.2013.06.080

Elsner, R. A., Hastey, C. J., Olsen, K. J., & Baumgarth, N. (2015). Suppression of long-lived humoral immunity following Borrelia burgdorferi infection. PLOS Pathogens, 11(7), 1-19. doi:10.1371/journal.ppat.1004976

Environmental Protection Agency. (n.d.). EPA’s clean power plan, climate change and children’s health. Washington, D.C.: Author. Retrieved September 2, 2015, from http://www.epa.gov/airquality/cppcommunity/children-climate-change.pdf

Estrada-Peña, A. (1998). Geostatistics and remote sensing as predictive tools of tick distribution: A cokriging system to estimate Ixodes scapularis (Acari: Ixodidae) habitat suitability in the United States and Canada from advanced very high resolution radiometer satellite imagery. Journal of Medical Entomology, 35(6), 989-995.

Etkin, S., Lenker, D. P., & Mills, E. J. (Eds.). (2005). Professional guide to disease (8th ed.). Philadelphia, PA: Lippincott Williams & Wilkins.

Fallon, B. A., Vaccaro, B. J., Romano, M., & Clemente, M. D. (2006). Lyme borreliosis: Neuropsychiatric aspects and neuropathology. Psychiatric Annals, 36(2), 120-128.

Feder, Jr., H. M., Johnson, B. J. B., O’Connell, S., Shapiro, E. D., Steere, A. C., Wormser, G. P., & the Ad Hoc International Lyme Disease Group. (2007). A critical appraisal of “chronic Lyme disease.” New England Journal of Medicine, 357(14), 1422-1430.

Feria-Arroyo, T. P., Castro-Arellano, I., Gordillo-Perez, G., Cavazos, A. L., Vargas-Sandoval, M., Grover, A., . . . Esteve-Gassent, M. D. (2014). Implications of climate change on the distribution of the tick vector Ixodes scapularis and risk for Lyme disease in the Texas-Mexico transboundary region. Parasites & Vectors, 7(199), 1-16.

Films Media Group. (2014). Racial disparities in cardiac care: Second opinion—taking charge of your health care [DVD]. Retrieved from http://www.films.com/ecTitleDetail.aspx?TitleID=32746

Fish, D., & Daniels, T. J. (1990). The role of medium-sized mammals as reservoirs of Borrelia burgdorferi in Southern New York. Journal of Wildlife Diseases, 26(3), 339-345.

Fix, A. D., Peña, C. A., & Strickland, G. T. (2000). Racial differences in reported Lyme disease incidence. American Journal of Epidemiology, 152(8), 756-759.

Gagnon, E. (2009). First Nations and Lyme disease. Paper presented at the Weaving Conference, Simon Fraser University, Burnaby, BC. Paper retrieved from http://www.sfu.ca/lovemotherearth/08classroom/papers/Lyme_disease.pdf

Genetic Science Learning Center, University of Utah Health Sciences. (n.d.). Epigenetics [Website]. Retrieved September 7, 2015, from http://learn.genetics.utah.edu/content/epigenetics

Girard, Y. A., Fedorova, N., & Lane, R. S. (2011). Genetic diversity of Borrelia burgdorferi and detection of B. bissettii-like DNA in serum of north-coastal California residents. Journal of Clinical Microbiology, 49(3), 945-954. doi:10.1128/JCM.01689-10

Greenstein, G., & Zajonc, A. G. (1997). The quantum challenge: Modern research on the foundations of quantum mechanics. Sudbury, MA: Jones and Bartlett.

Harvey, W. T., & Salvato, P. (2003). ‘Lyme disease’: Ancient engine of an unrecognized borreliosis pandemic? Medical Hypotheses, 60(5), 742-759. doi:10.1016/S0306-9877(03)00060-4

Hersh, M. H., Ostfeld, R. S., McHenry, D. J., Tibbetts, M., Brunner, J. L., Killilea, M. E., . . . Keesing, F. (2014). Co-infection of blacklegged ticks with Babesia microti and Borrelia burgdorferi is higher than expected and acquired from small mammal hosts. PLoS One, 9(6), 1-8.

Horowitz, R. I. (2013). Why can’t I get better? Solving the mystery of Lyme & chronic disease. New York: St. Martin’s Press.

Hyun, S. (n.d.). Lyme disease. Retrieved December 1, 2014, from http://www.austincc.edu/microbio/2704p/rp.htm

Infectious Diseases Society of America. (2011, May 10). Ten facts you should know about Lyme disease [Website]. Retrieved November 20, 2013, from http://www.idsociety.org/

Institute of Medicine, Committee on the Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. (2015). Beyond myalgic encephalomyelitis/chronic fatigue syndrome: Redefining an illness. Retrieved from http://www.iom.edu/~/media/Files/Report%20Files/2015/MECFS/MECFS_ReportBrief.pdf

International Lyme and Associated Diseases Society, Working Group. (2004). Evidence-based guidelines for the management of Lyme disease. Expert Review of Anti-infective Therapy, 2(1), S1-S13.

International Lyme and Associated Diseases Society (n.d.) Basic information about Lyme disease [Website]. Retrieved November 27, 2014, from http://www.ilads.org/Lyme/about-Lyme.php

Jarefors, S., Bennet, L., You, E., Forsberg, P, Ekerfelt, C., Berglund, J., & Ernerudh, J. (2006). Lyme Borreliosis reinfection: Might it be explained by a gender difference in immune response? Immunology, 118, 224-232. doi:10.1111/j.1365-2567.2006.02360x

Jemsek, J. (2006). Remarks to the North Carolina Medical Board. Retrieved from http://jemsekspecialty.com/

Johnson, L., Aylward, A., & Stricker, R. B. (2011). Healthcare access and burden of care for patients with Lyme disease: A large United States survey. Health Policy, 102, 64-71. doi:10.1016/j.healthpol.2011.05.007

Johnson, L., Wilcox, S., Mankoff, J., & Stricker, R. B. (2014). Severity of chronic Lyme disease compared to other chronic conditions: A quality of life survey. PeerJ, 2(e322), 1-21. doi:10.7717/peerj.322

Katz, A. (2012, June 21). Lyme disease: Where did the spirochete come from and how does it live around here? New Haven Register. Retrieved from http://www.nhregister.com/

Keesing, F., Holt, R. D., & Ostfeld, R. S. (2006). Effects of species diversity on disease risk. Ecology Letters, 9, 485-498. doi:10.1111/j.1461-0248.2006.00885.x

Keesing, F., Brunner, J., Duerr. S., Killilea, M., LoGiudice, K., Schmidt, K., . . . Ostfeld, R. S. (2009). Hosts as ecological traps for the vector of Lyme disease. Proceedings of the Royal Society B, 276, 3911-3919. doi:10.1098/rspb.2009.1159

Keirans, J. E., Hutcheson, J., Durden, L. A., & Klompen, J. S. H. (1996). Ixodes (Ixodes) scapularis (Acari: Ixodidae): Redescription of all active stages, distribution, hosts, geographical variation, and medical and veterinary importance. Journal of Medical Entomology, 33(3), 297-318.

Klempner, M. S., Wormser, G. H., Wade, K., Trevino, R. P., Tang, J., Kaslow, R. A., & Schmid, C. (2005). A case-control study to examine HLA haplotype associations in patients with posttreatment chronic Lyme disease. The Journal of Infectious Diseases, 192, 1010-1013. doi:0022-1899/2005/19206-0010

Kochhar, R., & Fry, R. (2014, December 12). Wealth inequality has widened along racial, ethnic lines since end of Great Recession. Pew Research Center. Retrieved from http://www.pewresearch.org/

Kosik-Bogacka, D. I., Kuzna-Grygiel, W., & Jaborowska, M. (2011). Ticks and mosquitoes as vectors of Borrelia burgdorferi s. l. in the forested areas of Szczecin. Folia biologica, 55(3-4), 143-146.

Krause, P. J., Telford II, S. R., Spielman, A., Sikand, V., Ryan, R., Christianson, D., . . . Persin, D. H. (1996). Concurrent Lyme disease and babesiosis. The Journal of the American Medical Association, 275(21), 1657-1660.

Kuhn, T. S. (2012). The structure of scientific revolutions (50th anniv. ed.). Chicago, IL: The University of Chicago Press.

Kugeler, K. J., Griffith, K. S., Gould, L. H., Kochanek, K., Delorey, M. J., Biggerstaff, B. J., & Mead, P. S. (2011). A review of death certificates listing Lyme disease as a cause of death in the United States, 52, 364-367.

Kugeler, K. J., Farley, G. M., Forrester, J. D., & Mead, P. S. (2015). Geographic distribution and expansion of human Lyme disease, United States. Emerging Infectious Diseases, 21(8), 1455-1457. doi:10.3201/eid2108.141878

Leland, D. K. (2013, August 19). Touched by Lyme: New CDC Lyme figures still ignore important issues[Web log post]. Lymedisease.org. Retrieved from http://lymedisease.org/

Lettau, L. A. (1991). From the Centers for Fatigue Control (CFC) Weekly Report: Lime Disease – United States. Annals of Internal Medicine, 114(7), 602.

Lockshin, M. D. (2001). Genome and hormones: Gender differences in physiology. Invited review: Sex ratio and rheumatic disease. Journal of Applied Physiology, 91, 2366-2373.

LoGiudice, K., Duerr, S. T. K., Newhouse, M. J., Schmidt, K. A., Killilea, M. E., & Ostfeld, R. S. (2008). Impact of host community composition on Lyme disease risk. Ecology, 89(10), 2841-2849.

Lovell, S., Kearns, R. A., & Friesen, W. (2007). Sociocultural barriers to cervical screening in South Auckland, New Zealand. Social Science & Medicine, 65(1), 138-150. doi:10.1016/j.socscimed.2007.02.042

Luger, S. W., & Krauss, E. (1990). Serologic tests for Lyme disease. Archives of Internal Medicine, 150, 761-763.

Lushenko, J. S. (1992). Letter to the editor. In L. Mermin (Ed.), Lyme disease 1991: Patient/physician perspectives from the U.S. & Canada. Madison, WI: Lyme Disease Education Project.

Lyme Action Network. (2015). Learn the facts: Tick-borne diseases and how to protect yourself [Advertorial insert]. Retrieved from http://www.jimapco.com/Lyme/learnthefacts.pdf

Makhani, N., Morris, S. K., Page, A. V., Brophy, J., Lindsay, L. R., Banwell, B. L., & Richardson, S. E. (2011). A twist on Lyme: The challenge of diagnosing European Lyme neuroborreliosis. Journal of Clinical Microbiology, 49(1), 455-457. doi:10.1128/JCM.01584-10

Markey, E. J., Blumenthal, R., Warren, E., Brown, S., & Durbin, R. J. (2014, July 2). [Letter to Brian Deese]. Retrieved from http://www.markey.senate.gov/imo/media/doc/2014-07-02_Deese_LDTs.pdf

Marques, A. (2008). Chronic Lyme disease: A review. Infectious Disease Clinics of North America, 22, 341-360. doi:10.1016/j.idc.2007.12.011

Mast, W. E., & Burrows, W. M. (1976). Erythema chronicum migrans and “Lyme Arthritis.” Journal of the American Medical Association, 236(21), 2392.

Mather, T. N., Duffy, D. C., & Campbell, S. R. (1993). An unexpected result from burning vegetation to reduce Lyme disease transmission risk. Journal of Medical Entomology, 30(3), 642-645.

Mayo Clinic Staff. (2014, May 5). Germs: Understand and protect against bacteria, viruses and infection [Website]. Retrieved September 7, 2015, from http://www.mayoclinic.org/

McCabe, G. J., & Bunnell, J. E. (2004). Precipitation and the occurrence of Lyme disease in the Northeastern United States. Vector-Borne and Zoonotic Diseases, 4(2), 143-148.

Middelveen, M. J., Bandoski, C., Burke, J., Sapi, E., Mayne, P. J., & Stricker, R. B. (2013). Isolation and detection of Borrelia burgdorferi from human vaginal and seminal secretions. Journal of Investigative Medicine, 62(1), 281-281.

Mount, G. A., Haile, D. G., & Daniels, E. (1997). Simulation of blacklegged tick (Acari: Ixodidae) population dynamics and transmission of Borrelia burgdorferi. Journal of Medical Entomology, 34(4), 461-484.

Murray, P. (1996). The widening circle: A Lyme disease pioneer tells her story. New York: St. Martin’s Press.

Nadelman, R. B., & Wormser, G. P. (2007). Reinfection in patients with Lyme disease. Clinical Infectious Diseases, 45, 1032-1038. doi:10.1086/521256

Nelson, C., Hojvat, S., Johnson, B., Peterson, J., Schriefer, M., Beard, B., . . . Mead, P. (2014). Concerns regarding a new culture method for Borrelia burgdorferi not approved for the diagnoses of Lyme disease. Morbidity and Mortality Weekly Report, 63(15), 333. Retrieved from http://www.cdc.gov/

Nelson, C. A., Saha, S., Kugeler, K. J., Delorey, M. J., Shankar, M. B., Hinckley, A. F., & Mead, P. S. (2015). Incidence of clinician-diagnosed Lyme disease, United States, 2005-2010. Emerging Infectious Diseases, 21(9), 1625-1631. doi:10.3201/eid2109.150417

Norcross, W. A., Ramirez, C., & Palinkas, L. A. (1996). The influence of women on the health care-seeking behavior of men. The Journal of Family Practice, 43(5), 475-480.

O’Connell, J., Yi, R., Wilson, C., Manson, S. M., & Acton, K. J. (2010). Racial Disparities in Health Status: A comparison of the morbidity among American Indian and U.S. adults with diabetes. Diabetes Care, 33(7), 1463-70. doi:10.2337/dc09-1652

Ogden, N. H., Bigras-Poulin, M., O’Callaghan, C. J., Barker, I. K., Lindsay, L. R., Maarouf, A., Smoyer-Tomic, K. E., . . . Charron, D. (2005). A dynamic population model to investigate effects of climate on geographic range and seasonality of the tick Ixodes scapularis. International Journal for Parasitology, 35, 375-389. doi:10.1016/j.ijpara.2004.12.013

Ostfeld, R. S. (2011). Lyme disease: The ecology of a complex system. New York: Oxford University Press.

Ostfeld, R. S., & Keesing, F. (2000). Biodiversity and disease risk: The case of Lyme disease. Conservation Biology, 14(3), 722-728.

Ostfeld, R. S., Canham, C. D., Oggenfuss, K., Winchcombe, R. J., & Keesing, F. (2006). Climate, deer, rodents, and acorns as determinants of variation in Lyme-disease risk. PLoS Biology, 4(6), 1058-1068. doi:10.1371/journal.pbio.0040145

Ostfeld, R. S., Price, A., Hornbostel, V. L., Benjamin, M. A., & Keesing, F. (2006). Controlling ticks and tick-borne zoonoses with biological and chemical agents. Bioscience, 56(5), 383-394.

Palmer, N. R. A., Geiger, A. M., Felder, T. M., Liu, L., Case, L. D., & Weaver, K. E. (2013). Racial/ethnic disparities in health care receipt among male cancer survivors. American Journal of Public Health, 103(7), 1306-1313. doi:10.2105/AJPH.2012.301096

Peters, K. (2010). Reasons why women choose a medical practice or a women’s health centre for routine health screening: Worker and client perspectives. Journal of Clinical Nursing, 19, 2557-2564. doi:10.1111/j.1365-2702.2010.03245.x

Poinar, Jr. G. (2014a). Rickettsial-like cells in the Cretaceous tick, Cornupalpatum burmanicum (Ixodida: Ixodidae). Cretaceous Research, 53, 1-5. doi:10.1016/j.cretres.2014.02.007

Poinar, Jr., G. (2014b). Spirochete-like cells in a Dominican amber Ambylomma tick (Arachnida: Ixodidae). Historical Biology, 26, 1-6. doi:10.1080/08912963.2014.897699

Pokorný, P. (1989). Incidence of spirochaeta Borrelia burgdorferi in arthropods and of antibodies in vertebrates. eskoslovenská Epidemiologie, Mikrobiologie, Imunologie, 38(1), 52-60.

Porter, R. S., & Kaplan, J. L. (Eds.). (2011). The MERCK manual (19th ed.). Whitehouse Station, NJ: Merck.

Preidt, R. (2015, June 19). Tick infection epidemic among American Indian tribes in Arizona: CDC. HealthDay. Retrieved from http://consumer.healthday.com/

Pritt, B. S., Mead, P. S., Hoang Johnson, D. K., Neitzel, D. F., Respicio-Kingry, L. B., Davis, J. P., . . . Petersen, J. M. (2016). Identification of a novel pathogenic Borrelia species causing Lyme borreliosis with unusually high spirochaetaemia: A descriptive study. Lancet Infectious Diseases, 1-9. doi:10.1016/S1473-3099(15)00464-8

Quammen, D. (2012). Spillover: Animal infections and the next human pandemic. New York: W. W. Norton & Co.

Rea, W. J. (1996). Chemical sensitivity: Tools, diagnosis and method of treatment (Vol. 4). Boca Raton, FL: CRC Press.

Richter, D., Spielman, A., Komar, N., & Matuschka, F-R. (2000). Competence of American robins as reservoir hosts for Lyme disease spirochetes. Emerging Infectious Diseases, 6(2), 133-138.

Rodgers, S. E., & Mather, T. N. (2006). Evaluating satellite sensor-derived indices for Lyme disease risk prediction. Journal of Medical Entomology, 43(2), 337-343.

Ross, M. (2014, May 2). A review of Lyme infection tests. Pass or fail. [Web log post]. Treat Lyme. Retrieved from http://www.treatLyme.net/treat-Lyme-book/a-review-of-Lyme-infection-tests-pass-or-fail

Ross, M., & Brooke, T. (2013). Supplements and advanced treatments for Lyme and associated diseases. [Web log post]. Treat Lyme. Retrieved November 27, 2014, from http://www.treatLyme.net/Lyme-treatment-guidelines

Ross, M., & Brooke, T. (2014). What is Lyme disease? A mess of things [Web log post]. Treat Lyme. Retrieved August 31, 2015, from http://www.treatLyme.net/treat-Lyme-book/what-is-Lyme-disease-a-mess-of-things

Santow, G. (1992, May). Gender differences in health risks and use of services. Paper presented at the meeting of the International Conference on Population and Development, 1994, Expert Group Meeting on Population and Women, Gaborone, Botswana.

Sapi, E., Pabbati, N., Datar, A., Davies, E. M., Rattelle, A., & Kuo, B. A. (2013). Improved culture conditions for the growth and detection of Borrelia from human serum. International Journal of Medical Sciences, 10(4), 362-376. doi:10.7150/ijms.5698

Savely, V. R. (2008). Update on Lyme disease: The hidden epidemic. Journal of Infusion Nursing, 31(4), 236-240.

Schmid, G. P. (1984). The global distribution of Lyme disease. The Yale Journal of Biology and Medicine, 57, 617-618.

Shah, S. (2010). The fever. New York: Picador.

Simms, M., Fortuny, K., & Henderson, E. (2009). Racial and ethnic disparities among low-income families. Urban Institute. Retrieved www.urban.org/sites/default/files/alfresco/publication-pdfs/411936-Racial-and-Ethnic-Disparities-Among-Low-Income-Families.PDF

Simons, J. (2009/2010). Effective treatment for chronic viruses. The Lyme Times, 58, 29-30.

Sonenshine, D. E. (1993). Biology of ticks (Vol. 2). New York: Oxford University Press.

Spielman, A., Telford III, S. R., & Pollack, R. J. (1993). The origins and course of the present outbreak of Lyme disease. In H. S. Ginsberg (Ed.), Ecology and environmental management of Lyme disease (pp. 83-96). New Brunswick, NJ: Rutgers University Press.

Steere, A. C., & Malawista, S. E. (1979). Cases of Lyme disease in the United States: Locations correlated with distribution of Ixodes dammini. Annals of Internal Medicine, 91, 730-733.

Steere, A. C., Malawista, S. E., Syndman, D. R., Shope, R. E., Andiman, W. A., Ross, M. A., & Steele, F. M. (1977). Lyme Arthritis: An epidemic of oligoarticular arthritis in children and adults in three Connecticut communities. Arthritis and Rheumatism, 20(1), 7-17.

Stricker, R. B. (2007). Counterpoint: Long-term antibiotic therapy improves persistent symptoms associated with Lyme disease. Antibiotic Therapy and Lyme Disease, 45, 149-157. doi:10.1086/518853

Stricker, R. B., & Johnson, L. (2009). Gender bias in chronic Lyme disease. Journal of Women’s Health, 18(10), 1717-1718. doi:10.1089/jwh.2009.1657

Stricker, R. B., & Johnson, L. (2010). Lyme disease diagnosis and treatment: Lessons from the AIDS epidemic. Minerva Medica, 101(6), 419-425.

Stricker, R. B., & Johnson, L. (2011). Lyme disease: The next decade. Infection and Drug Resistance, 4, 1-9. doi:10.2147/IDR.$15653

Stricker, R. B., & Johnson, L. (2014). Lyme disease: Call for a “Manhattan Project” to combat the epidemic. PLoS Pathogen, 10(1), 1-3. doi:10.1371/journal.ppat.1003796

Stricker, R. B., & Lautin, A. (2003). The Lyme wars: Time to listen. Expert Opinion on Investigational Drugs, 12(10), 1609-1614.

Taylor, L. H., Latham, S. M., & Woolhouse, M. E. J. (2001). Risk factors for human disease emergence. Philosophical Transactions of the Royal Society, 356, 983-989. doi:10.1098/rstb.2001.0888

Telford III, S. R., Mather, T. N., Moore, S. I, Wilson, M. L., & Spielman, A. (1988). Incompetence of deer as reservoirs of the Lyme disease spirochete. The American Journal of Tropical Medicine and Hygiene, 39(1), 105-109.

Teltow, G. J., Fournier, P. V., & Rawlings, J. A. (1991). Isolation of Borrelia burgdorferi from arthropods collected in Texas. The American Journal of Tropical Medicine and Hygiene, 44(5), 469-474.

Thompson, A., & Climate Central. (2015, July 30). What global warming means for 4 of summer’s worst pests. Scientific American. Retrieved from http://www.scientificamerican.com/

Tippett, K. (Executive Producer). (2015, July 30). On Being [Audio podcast]. Retrieved from http://www.onbeing.org/

U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. (2007, June 15). Lyme disease – United States, 2003-2005. Morbidity and Mortality Weekly Report, 56(23), 573-576.

U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. (2011, November 15). Two-step laboratory testing process [Website]. Retrieved February 22, 2015, from http://www.cdc.gov/Lyme/diagnosistesting/LabTest/TwoStep/

U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. (2013a, January 11). Lyme disease transmission [Website]. Retrieved September 9, 2013, from http://www.cdc.gov/Lyme/transmission/index.html

U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. (2013b, August 19). CDC provides estimate of Americans diagnosed with Lyme disease each year. Retrieved from http://www.cdc.gov/

U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. (2013c, September 4). Lyme disease data [Website]. Retrieved September 9, 2013, from http://www.cdc.gov/Lyme/stats/index.html

U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. (2013d, October 4). FY 2013 full year CR operating plan. Retrieved October 6, 2013, from http://www.cdc.gov/fmo/topic/Budget%20Information

U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. (2014, May 8). Lyme disease (Borrelia burgdorferi) [Website]. Retrieved November 27, 2014, from http://wwwn.cdc.gov/NNDSS/script/casedef.aspx?CondYrID=752&DatePub=1/1/2011

U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Disease. (2008). Finding the cause of Lyme disease [Website]. Retrieved from http://www.niaid.nih.gov/topics/LymeDisease/research/Pages/cause.aspx

U.S. Department of Health & Human Services, National Partnership for Action. (2011). HHS action plan to reduce racial and ethnic disparities: A nation free of disparities in health and health care. Washington, D.C.: Author. Retrieved from http://minorityhealth.hhs.gov/npa/files/plans/hhs/hhs_plan_complete.pdf

U.S. Senate, Committee on Labor and Human Resources. (1993, August 5). Lyme disease: A diagnostic and treatment dilemma (S. Hrg. 103-265). Washington, D.C.: U.S. Government Printing Office.

Vayssier-Taussat, M., Moutailler, S., Féménia, F., Raymond, P., Croce, O., La Scola, B., . . . Raoult, D. (2016). Identification of novel zoonotic activity of Bartonella spp., France. Emerging Infectious Diseases, 22(3), 457-462. doi: 10.3201/eid2203.150269

Vyas, J. M. (2014). Lyme disease. In MedlinePlus. Retrieved December 23, 2014, from http://www.nlm.nih.gov/medlineplus/ency/article/001319.htm

Walters, M. J. (2003). Six modern plagues and how we are causing them (pp. 89-111). Washington, D.C.: Island Press.

Weber, K., Schierz, G., Wilske, B., & Preac-Mursic, V. (1984). European Erythema migrans disease and related disorders. The Yale Journal of Biology and Medicine, 57, 463-471.

Whitacre, C. C., Reingold, S. C., & O’Looney, P. A. (1999). A gender gap in autoimmunity. Science, 283, 1277-1278.

White, B., Seaton, R. A., & Evans, T. J. (2013). Quarterly Journal of Medicine, 106, 133-138. doi:10.1093/qjmed/hcs189

World Health Organization. (2010). International statistical classification of diseases and related health problems (10th ed.) [Online version]. Retrieved from http://www.who.int/classifications/icd/en/

World Health Organization. (2014). Ebola virus disease. Retrieved from http://www.who.int/mediacentre/factsheets/fs103/en/

Wormser, G. P., Dattwyler, R. J., Shapiro, E. D., Halperin, J. J., Steere, A. C., Klempner, M. S., . . . Nadelman, R. B. (2006). The clinical assessment, treatment, and prevention of Lyme disease, human granulocytic anaplasmosis, babesiosis: Clinical practice guidelines by the Infectious Diseases Society of America. Clinical Infectious Diseases, 43(9), 1089-1134. doi:10.1086/508667

Wormser, G. P., & Shapiro, E. D. (2009). Implications of gender in chronic Lyme disease. Journal of Women’s Health, 18(6), 831-834. doi:10.1089/jwh.2008.1193

Yumkella, F. (1996). Women, onchocerciasis and ivermectin in Sierra Leone (Gender and Tropical Diseases Resource Papers No. 2). Retrieved from World Health Organization website: http://www.who.int/iris/handle/10665/63318

Access To Care Services & Patient Support: Future

PeerJ. 2014 Mar 27;2:e322. doi: 10.7717/peerj.322. eCollection 2014.

Severity of chronic Lyme disease compared to other chronic conditions: a quality of life survey. Johnson L1, Wilcox S1, Mankoff J2, Stricker RB3.

Front Med (Lausanne). 2017 Dec 14;4:224. doi: 10.3389/fmed.2017.00224. eCollection 2017.

The Clinical, Symptom, and Quality-of-Life Characterization of a Well-Defined Group of Patients with Posttreatment Lyme Disease Syndrome.

Rebman AW1, Bechtold KT2, Yang T1, Mihm EA1, Soloski MJ1, Novak CB1, Aucott JN1.

PLoS One. 2015 Feb 4;10(2):e0116767. doi: 10.1371/journal.pone.0116767. eCollection 2015.

Health care costs, utilization and patterns of care following Lyme disease.

Adrion ER1, Aucott J2, Lemke KW3, Weiner JP1.

http://mgaleg.maryland.gov/2016RS/chapters_noln/Ch_450_sb0926T.pdf

Engstrom et al. J Clin Microbiol 1995;33:419-27

Ledue et al. J Clin Microbiol 1996;34:2343-50

Trevejo et al. J Infect Dis 1999;179:931-8

Nowakowski et al. Clin Infect Dis 2001;33:2023-7

Bacon et al. J Infect Dis 2003;187:1187-99

https://www.niaid.nih.gov/topics/lymedisease/Pages/diagnostics.aspx

Experimental Test Detects Signs of Lyme Disease Near Time of Infection
https://www.nist.gov/news-events/news/2016/02/new-experimental-test-detects-signs-lyme-disease-near-time-infection

https://www.sciencedaily.com/releases/2017/01/170112141153.htm

https://hab.hrsa.gov/about-ryan-white-hivaids-program/ryan-white-hivaids-program-legislation

10 Steps for Coping With a Chronic Condition

https://www.health.harvard.edu/staying-healthy/10-steps-for-coping-with-a-chronic-condition

The impact of patients’ chronic disease on family quality of life: an experience from 26 specialties

Helping Patients Take Charge of Their Chronic Illnesses

https://www.aafp.org/fpm/2000/0300/p47.html

(American Academy of Family Physicians)

Infect Drug Resist. 2016 Sep 13;9:215-9. doi: 10.2147/IDR.S114770. eCollection 2016.

Lyme disease: the promise of Big Data, companion diagnostics and precision medicine.

Stricker RB1, Johnson L2.

https://www.lymedisease.org/mylymedata/

Ethical Decision Making About Lyme Disease Policy

https://www.youtube.com/watch?v=2iQweqOZnXU

Qual Health Res. 2017 Mar;27(4):534-546. doi: 10.1177/1049732315619380. Epub 2016 Jul 10.

Living in Limbo: Contested Narratives of Patients With Chronic Symptoms Following Lyme Disease.

Rebman AW1,2, Aucott JN2, Weinstein ER1,2, Bechtold KT2, Smith KC3, Leonard L3,4.

Dusenbery, Maya (2018). Doing Harm, Harper Collins

Centers of excellence in healthcare institutions: what they are and how to assemble them James K. Elrod1 and John L. Fortenberry, Jr.1,2

http://cdmrp.army.mil/aboutus

NY Times, Gina Kolata, https://www.nytimes.com/2009/06/28/health/research/28cancer.html

Health system frameworks and performance indicators in eight countries: A comparative international analysis Jeffrey Braithwaite,1 Peter Hibbert,1 Brette Blakely,1 Jennifer Plumb,2 Natalie Hannaford,3 Janet Cameron Long

Appendix 2: Access to Care Services and Support to Patients Subcommittee Agendas and Top Line Summaries

Meeting Summary 1, February 28, 2018

Agenda

1. Roll call
2. Discussion of the working plan
3. Vote on the working plan
4. Discussion about the first draft submission of the "Issues and Priorities" report
5. Vote to approve and have the first draft of the "Issues and Priorities" report submitted to the writer
6. Discussion about the "Methods" report submission
7. Vote to submit the "Methods" report to the writer as a completed document
8. Technology - accessing files and email
9. Wrap-up

Summary of Key Points

• Are Lyme disease and other tick-borne diseases new?
• What are the needs of the public and patients relating to tick-borne diseases?
• Is there a lack of access to affordable medical care for people with tick-borne diseases?
• Are there barriers to patients seeking proper diagnosis and treatment?
• Are there barriers to diagnosis and treatment that exist at the federal or state government levels?
• Key Discussion Point-The Past, Present, and Future of Access to Care and Support to Patients
• Key Discussion Point-Barriers to Accessing and Providing Patient Care and Support
• Key Discussion Point-The Past, Present, and Future of Access to Care and Support to Patients
• Key Discussion Point-Barriers to Accessing and Providing Patient Care and Support

Meeting Summary 2, March 7, 2018

Agenda

• Roll Call
• Call Summary from Wednesday, 28 FEB 2018
• Group Nominations and Decision for the Non-Federal Subcommittee Co-Chair
• Discussion of the Voting and Decision-Making Process for Subcommittees of the Tick-Borne Disease Working Group
• Timeline for Deliverables to the Tick-Borne Disease Working Group
• Next Deliverable-Background and/or Methods Section(s)
• Division of the Six Issues/Priorities
• Technology - Accessing Files
• Other Issues/Wrap-Up

Summary of Key Points

• Key Discussion Point- Group nominations and decision for non-Federal subcommittee co-chair
• Key Discussion Point- Discussion of the voting and decision-making process for subcommittees of the Tick-Borne Disease Working Group
• Key Discussion Point-Timeline and Division of Work on Deliverables to the Tick-Borne Disease Working Group
• Key Discussion Point-Organization of Topics in the Report to the Tick-Borne Disease Working Group
• Key Discussion Point-Establishing a Work Plan and Identifying Possible Speakers

Meeting Summary 3, March 14, 2018

Agenda

• Roll call
• Vision, Values, and Ethics pledge for the TBDWG and its subcommittees
• Open discussion and reflection on the above
• Open discussion on questions/observations regarding unity in the Lyme/TBD community, specifically with patient advocacy
• Announcement of new co-chair with vote tallies for the nominees and verbal acceptance of position by the member selected
• Revised Timeline for Access to Care/Patient Support deliverables to TBDWG
• Next deliverable-Background and Methods sections
• Division of the six Issues/Priorities identified in Table 2 of the draft section and outline of work plan
• Other issues/Wrap-up

Summary of Key Points

• Key Discussion Point-Review and Discussion of Ethics Pledge, Mission, Vision, and Values
• Key Discussion Point-Unity and Division in the Lyme/Tick-Borne Disease Community

Meeting Summary 4, March 28, 2018

Agenda

• Roll call
• Addressing Issues of Communication
• Division of writing tasks for the subcommittee report to the Tick-Borne Disease Working Group-work plan/outline
• Other issues/Wrap-up

Summary of Key Points

• Key Discussion Point-Communication Within and Outside the Subcommittee
• Key Discussion Point-Issues and Priorities

Meeting Summary 5, April 4, 2018

Agenda

• Roll call
• Open forum for DFO and TBDWG Vice-Chair if needed
• Discussion of documents submitted to subcommittee as well as other relevant documents/issues
• Update on speaker presentations on next three calls
• Division of the subcommittee report to TBDWG-- work plan/outline
• Other issues/Wrap-up

Summary of Key Points

• Key Discussion Point-Working Group Processes
• Key Discussion Point-Topics to Include in the Report to the Tick-Borne Disease Working Group

Meeting Summary 6, April 18, 2018

Agenda

• Roll call
• Updates from DFO and TBDWG Vice-Chair as needed
• General housekeeping, especially regarding any issues with SharePoint
• Speaker presentations

Presentation 1: Patient Access to Care: The Role of Physician Education

Betty Maloney, MD; Minnesota Lyme activist and President of Partnership for Healing & Health

Presentation 2: Global Lyme Alliance Activities

Scott Santarella; Global Lyme Alliance

Presentation 3: Experiences as an Investigative Reporter Researching Lyme Diseases

Mary Beth Pfeiffer; Author/Journalist (LYME: The First Epidemic of Climate Change)

Meeting Summary 7, April 25, 2018

Agenda

• Roll call
• Welcome and introduction of new member to the subcommittee
• Updates from DFO and TBDWG Vice-Chair as needed
• Speaker presentations

Presentation 1: Cohen Lyme and Tick-borne Disease Initiative

Bennett (Ben) Nemser, MPH; Epidemiology; Senior Program Officer, Steven & Alexandra Cohen Lyme Foundation

Presentation 2: Recent Work Helping Patients with Insurance Company Denials and Working to Change State Laws

Susan Green; Legislative Counsel, NatCapLyme

Presentation 3: Access to Care Challenges

Nevena Zubcevik, DO, MSPT; Clinical Co-Director, Spaulding Rehabilitation Network

Meeting Summary 8, May 2, 2018

Agenda

1. Roll call
2. Speaker presentations

Presentation 1: MyLyme Data

Lorraine Johnson, JD, MBA; Chief Executive Officer, LymeDisease.org

Presentation 2: Creation of the Focus on Lyme Biorepository

Tammy Crawford; Founder, Executive Director, Focus on Lyme

Presentation 3: Barriers and Opportunities for Improved Access to Care and Support to Patients

Richard Horowitz, MD; Medical Director, Hudson Valley Healing Arts Center

Meeting Summary 9, May 3, 2018

Agenda

• Roll call
• Determination of Potential Actions for the final report to the Tick-Borne Disease Working Group

Appendix 3: Informed Consent for Treatment of Persistent Lyme Disease

This information is accessible on the LymeDisease.org website at https://www.lymedisease.org/wp-content/uploads/2018/05/Informed-consent-for-Lyme-treatment.pdf.

Appendix 4: The "Lyme-Literate" Mental Health Evaluation

Sheila M. Statlender, PhD

The following list is not meant to be all-inclusive, but rather to provide examples of the types of questions which are helpful in screening for possible Lyme-induced neuropsychiatric symptoms in our patients.

1. Are the symptoms of new onset? Do they represent a marked change, in terms of previous level of functioning?
2. Does the patient live in a Lyme-endemic area or has s/he visited on recently?
3. Does the patient engage in activities that are high-risk, in terms of Lyme disease? Examples include gardening, hiking and camping, although many tick bites occur in the back yard. Does s/he own an indoor/outdoor animal?
4. Does the patient report a history of tick attachment(s)?
5. Has the patient ever been treated for Lyme or another tick-borne disease? If so, was treatment administered and for how long?
6. Has the patient ever suspected that s/he had Lyme disease, but was told that it was ruled out?
7. Has the patient ever noticed improvement in symptoms after a course of antibiotics for another reason? Ever noticed that antibiotics made them feel worse? (Jarisch-Herxheimer reaction)
8. Does that patient report new onset medical symptoms? What type? Typical examples may include but are not limited to new onset headaches, often of migraine intensity, sever fatigue, joint pain, gastrointestinal distress, shooting pains and/or tingling in the extremities, light or sound sensitivity.
9. Does the patient report new onset cognitive difficulties? These may include but are not limited to difficulties with concentration and attention, recent memory, reduced processing speed, as well as a tendency to get lost, even in familiar places. The informal term for these combined difficulties is "brain fog."
10. Does the patient have family members or a family pet that was diagnosed with Lyme disease?