Lyme and other tick-borne diseases are complex medical conditions that lack a unified consensus on diagnostic testing and treatment. Because there is a lack of medical consensus on how to treat these conditions, Lyme-literate providers, who practice on the cutting edge of medicine, can find themselves vulnerable to medical board and other regulatory agency investigations. A recent survey of 155 Lyme-literate medical providers found that 39% were reported to either a medical board, insurer, or subjected to a hospital-based quality improvement inquiry.1 This survey has drawn attention to the challenges faced by medical providers in treating these complex and often misunderstood conditions. Exploring the reasons behind the complexity of treating tick-borne diseases sheds light on the ever increasing prevalence of Lyme disease and the growing demand for more comprehensive treatment approaches.
Understanding Lyme Disease
Lyme disease is the fastest growing vector-borne disease in the United States2 with the CDC estimating 476,000 new cases each year.3 While many patients will improve after a short course of antibiotics, up to 35% will experience late stage symptoms4 including cognitive dysfunction, memory loss, severe headache, fatigue, chest pain, shortness of breath, difficulty sleeping, lightheadedness, depression, and anxiety for which a single course of antibiotics does not resolve their symptoms.5
In addition to Lyme disease, there are a number of other tick-borne infections which may present in patients on their own, or in combination with Lyme disease including: Rocky Mountain Spotted Fever, Babesia, Bartonella, Ehrlichiosis, Tick Borne Relapsing Fever, Morgellons, Powassan Virus and Alpha-gal Syndrome, to name a few. Each of these diseases have different symptoms and some can cause death if not treated effectively.
The diagnosis of Lyme disease remains a complex process due in part to wide ranging symptoms and a poor CDC approved diagnostic test, which has been found to miss 71% of patients presenting with a Lyme rash greater than 5cm in size.6 For those reasons, many patients go undiagnosed for years, which in turn leads to more intense symptoms and a higher probability of treatment failure. Patients who do not recover after an initial round of treatment, typically 28 days of antibiotics, or who do not test positive with the flawed CDC approved test, are often denied further treatment due in part to the Infectious Diseases Society of America (IDSA)’s guidelines which urge against further treatment.
In the past, providers who treat patients beyond the IDSA’s recommendations have become susceptible to medical board proceedings despite their reliance on 700 per-reviewed research studies indicating the bacteria can persist long after treatment has concluded.7 These providers are known as Lyme-literate providers and they follow the guidelines produced by the International Lyme and Associated Diseases Society. Treatment from a Lyme-literate provider may consist of long-term antibiotics, herbal remedies, supplements, or a combination of various treatments.
This article aims to assist Lyme-literate providers, attorneys, and insurers in understanding potential liability that providers may face for prescribing treatment, including long-term antibiotics, beyond the IDSA guidelines and provide strategies to help reduce legal risks.
History of Claims Related to Lyme-Literate Providers
Due to the strong influence the IDSA has over medical journals, hospitals, and medical boards, the IDSA guidelines are often viewed as the standard of care for Lyme disease treatment in the medical community at large.
As a result, doctors who treat patients beyond the IDSA’s guidelines can find themselves susceptible to medical board proceedings despite scientific evidence showing Lyme disease can persist beyond standard treatment and despite their reliance on the International Lyme and Associated Diseases Society’s guidelines. For example, Dr. William Brown of Portland, Oregon was cited by a reviewer of an HMO insurance company for treating patients with Lyme disease. Upon investigation, the medical board allowed Dr. Brown to keep his medical license after he agreed to stop treating patients with Lyme disease, despite the fact that 5 out of 6 patients showed drastic improvement.8
In response to the growing number of claims against medical providers, patients and Lyme disease activists have worked with state legislatures to pass laws that offer additional protection to Lyme-literate providers. For example Illinois law states:
The Department shall not revoke, suspend, place on probation, reprimand, refuse to issue or renew, or take any other disciplinary or non-disciplinary action against the license or permit issued under this Act to practice medicine to a physician… for experimental treatment for Lyme disease or other tick-borne diseases, including, but not limited to, the prescription of or treatment with long-term antibiotics.9
While laws that allow Lyme-literate providers to treat patients with long-term antibiotics are extremely valuable, they are limited to 8 states that have passed similar statutes. For this reason, the following risk management techniques may help reduce some risk in treating beyond the IDSA’s guidelines.
Recordkeeping, Risk Management, and Practice Pointers for Medical Professionals Treating Lyme Disease: Minimizing Implications of Claims
Adequate record keeping is crucial in the treatment of Lyme disease in showing that a differential diagnosis was made and all treatment is medically necessary due to vast differences in treatment responses from patient to patient, inaccurate diagnostic tests, and complex treatment regiments. By thoroughly documenting the patient’s symptoms – both objective and subjective – potential exposure to tick bites, and initial test results, healthcare providers can establish a baseline for tracking the progressions of the disease and evaluating treatment effectiveness.
1. Stay Informed and Updated:
As medical knowledge surrounding Lyme disease continues to evolve, it is crucial for medical professionals to stay up to date with the latest research and treatment options by attending relevant conferences or workshops and engaging in continuing medical education credits specific to tick-borne diseases.
2. Accurate Diagnosis and Documentation:
Medical professionals must perform a thorough, differential diagnosis to rule out other conditions with similar symptoms. It is important to document the patient's medical history, symptoms, physical examination findings, and any diagnostic test results as well as the risks of treatment vs. nontreatment. Clear and comprehensive documentation provides a solid foundation for your treatment decisions and can be invaluable if a claim arises in the future.
3. Informed Consent and Shared Decision-Making:
Engaging in open and transparent communication with patients and explaining the risks, benefits, and potential alternatives of various treatment options allows patients to make informed decisions about their health. Providers should implement informed consent forms, clearly document discussions with the patient, and note the patient's agreement to the chosen course of treatment. Shared decision-making empowers patients and reduces the risk of claims related to inadequate communication or patient dissatisfaction.
4. Collaboration and Referrals:
Lyme disease is a complex condition, and collaboration with other Lyme-literate medical professionals can enhance patient care and minimize the risk of claims. Collaborative efforts demonstrate a commitment to comprehensive care and can help address complex cases more effectively.
5. Document Reliance on Scientific Studies and Guidelines:
Provide documentation on which guidelines and/or scientific studies you are following in determining the proper treatment protocol for each patient. Placing an emphasis on the scientific reasoning behind your clinical judgment can increase the odds of a claim being dismissed early on in the process.
6. Continual Monitoring and Follow-up:
Implement a structured follow-up plan to monitor your patients' progress and adjust treatment as necessary. Regularly assess treatment outcomes, document changes in symptoms, and make appropriate modifications based on patient response. If symptoms persist, explain why Lyme or other tick-borne diseases are still suspected as the culprit and re-test as necessary. Consistent monitoring demonstrates your commitment to patient care and helps identify potential issues before they escalate.
7. Thorough Documentation of Treatment Decisions:
Document the rationale behind your treatment decisions, including the choice of medications, dosage adjustments, and the duration of treatment. This documentation should reflect your clinical judgment, considerations of patient-specific factors, and discussions held with the patient. Clear documentation demonstrates a thoughtful and well-reasoned approach, which can be invaluable in case of future claims.
8. Patient Education and Empowerment:
Educate your patients about Lyme disease, its course, and potential treatment outcomes. Provide resources, both written and verbal, that help patients understand the nature of their condition, the rationale behind treatment decisions, and realistic expectations. Empowering patients with knowledge and understanding can foster stronger doctor-patient relationships and reduce the likelihood of claims resulting from misunderstandings or unrealistic expectations.
9. Risk Management Education and Insurance Coverage:
Consider participating in risk management education programs specifically designed for medical professionals treating Lyme disease. These programs can provide valuable insights, guidance, and strategies for reducing the risk of claims. Additionally, ensuring you have appropriate professional liability insurance coverage that specifically addresses medical board proceedings may help reduce the financial risk associated with potential claims.
What if Despite Best Efforts Providers Find Themselves Embroiled in a Legal Dispute?
Lyme disease claims can be tricky due to the nature and complexity of emerging treatments as well as the lack of consensus on persistent infection in the medical field. In addition, professional liability insurance may not always cover medical board proceedings, so providers need to consider whether additional insurance would be beneficial. Medical board decisions can result in everything from a reprimand and fines to a license suspension or revocation. The procedures for complaints to medical boards vary widely state to state. Ordinarily, there is an initial investigation, which will culminate in a letter of concern, dismissal, or the opening of a formal investigation. In preparing a response to the initial investigation, providers should seek legal counsel and be sure to request the complaint as well as all associated patient files up front. They should also request that the full chart be entered into evidence and hire a court reporter to document the interview. In the end, proper record keeping, patient communication and keeping abreast of current practices and advancements in the area of Lyme disease are the best protection that medical practitioners can employ as they navigate the weeds posed by Lyme disease.
By implementing these risk management strategies and practice pointers, medical professionals can minimize the likelihood of being implicated in claims related to Lyme disease treatment. Consistently delivering high-quality, evidence-based care while maintaining clear and thorough documentation serves to protect both patients and healthcare providers, fostering a positive and effective treatment experience.
1 Lorraine B. Johnson & Elizabeth L. Maloney, Access to Care in Lyme Disease: Clinician Barriers to Providing Care, HEALTHCARE 10, no. 10: 1882. (2022), https://doi.org/10.3390/healthcare10101882.
2 Draft National Strategy for Vector-Borne Diseases: We Want to Hear from You, US DEPT. OF HEALTH & HUMAN SERVICES (Dec 13, 2022), https://www.hhs.gov/blog/2022/12/13/draft-national-strategy-for-vector-borne-diseases-we-want-to-hear-from-you.html#.
3 How Many People Get Lyme Disease?, CTRS. FOR DISEASE CONTROL & PREVENTION (Jan. 13, 2021), https://www.cdc.gov/lyme/stats/humancases.html.
4 TICK-BORNE DISEASE WORKING GROUP, 2020 REPORT TO CONGRESS 62–63 (2020).
5 Lyme Disease Basics for Providers, INT’L LYME & ASSOCIATED DISEASES SOC’Y, https://www.ilads.org/research-literature/lyme-disease-basics-for-providers.
6 Horn EJ, Dempsey G, Schotthoefer AM, Prisco UL, McArdle M, Gervasi SS, Golightly M, De Luca C, Evans M, Pritt BS, Theel ES, Iyer R, Liveris D, Wang G, Goldstein D, Schwartz I. 2020. The Lyme Disease Biobank: characterization of 550 patient and control samples from the East Coast and Upper Midwest of the United States, J Clin Microbiol 58:e00032-20, (2020) https://doi.org/10.1128/JCM.00032-20.
7 Plaintiffs’ First Amended Complaint at 18, Torrey v. Infectious Diseases Soc’y of Am., No.5:17-cv-00190-RWS (E.D. Tex. Mar. 25, 2019).
8 Jennifer Barrett, It’s About Lyme: Why Congress Must Enact Medical Insurance Coverage Laws for Lyme Disease Patients Now, 45 SEATTLE U. L. REV. SUPRA 50 (2022).
9 225 ILL. COMP. STAT. § 60/22(c) (2021).