Why Congress Must Enact Medical Insurance Coverage Laws for Lyme Disease

Jennifer Barrett is an Associate Attorney at Wood, Smith, Henning & Berman LLP. As a patient, she has made Lyme disease a focus of her life’s mission. In 2022, she published a law journal article on mandating Lyme disease insurance coverage.

This article provides an overview of Lyme disease and its prevalence in the United States. Despite scientific evidence showing the infection can persist long after initial treatment, most insurance companies restrict access to treatment beyond twenty-eight days, leaving patients to bear much of the financial burden. Barrett argues that the existing state-by-state approach to addressing Lyme disease is insufficient; therefore, Congress must enact legislation mandating coverage for the treatment of clinically diagnosed Lyme disease and co-infections based on the International Lyme and Associated Diseases Society’s Guidelines.

This blog is an excerpt from Jennifer’s publication in the Seattle University Law Review. It focuses on the actual cost of Lyme disease to patients and the medical system. The full publication can be found via the link:  It’s About Lyme: Why Congress Must Enact Medical Insurance Coverage Laws for Lyme Disease Patients Now Coverage Laws for Lyme Disease Patients Now.


The Cost of Lyme Disease

Limited Government Funding

One of the major obstacles to uncovering the cause of chronic Lyme disease and finding a cure is the lack of government funding for research as compared to other vector-borne diseases. In 1993, the U.S. Senate Committee on Labor and Human Resources held a hearing entitled: Lyme Disease: A Diagnostic and Treatment Dilemma. After hearing patient stories, Senator Bill Bradley noted: “This is an enormous national problem that we are refusing to address . . . . NIH has to get its act together . . . .”. Senator Metzenbaum followed, stating:

“I think [the testifying constituents] have sounded a clarion call that we ought to get off our butts and do something about this. Frankly, I think it is an illness that has been swept under the carpet, and not many people have paid attention to it…. I have heard of Lyme disease, but it hasn’t struck me with the strength of your testimony today.”

Yet, despite the Senators’ concerns, it appears Congress did little to help.

A few years later in 1998, Senator Christopher J. Dodd of Connecticut highlighted the issue in his proposal for a $3 million amendment to the Department of Defense budget for Lyme disease research, stating “[l]ong term treatment expenses can exceed $100,000 per person—a phenomenal cost to society. But an even greater price is paid by the victims and their families. We can put no price tag on the emotional costs associated with this disease.” And in relation to the military, he noted: “The growing number of cases has led the Department of Defense to recognize that Lyme Disease and other tick-borne illnesses pose a potentially serious health threat to our troops, civilian employees, and residents at military installations all over the world—and thus a threat to our military readiness.” Yet, as of today, Lyme disease is missing from the U.S. Wartime Disability Compensation Statute.

By 2019, little had changed in terms of government assistance in finding a cure for Lyme disease. The CDC estimates around 476,000 Americans are diagnosed with Lyme disease each year, yet the NIH dedicated only $32 million to research the disease in 2019. In contrast, the CDC estimates only 2,000 U.S. residents are infected with malaria each year, and most cases are from travelers abroad. However, the NIH spent $254 million on research for malaria and the malaria vaccine. Breaking the research dollars down by diagnosis shows the NIH spent $127,000 in research for each malaria diagnosis in 2019 and only $67 for each Lyme disease diagnosis.

The Kay Hagan Tick Act, passed in 2019 and the Omnibus Appropriations bill of 2021 expand research funding but do so with a caveat and provide little help to those currently suffering from the disease. The Kay Hagan Tick Act provides $10 million for new centers for excellence in vector-borne diseases and $20 million for enhanced support for health departments.145 But before passing the bill, senators removed all mention of the word “Lyme” and removed the requirement for proportional funding based on the disease burden in the U.S., which would have made Lyme disease first in line for funding. As a result, activists fear a larger portion of the funding will now go to other vector-borne illnesses like Zika, Malaria, and West Nile Virus, which have received more funding than Lyme disease in past years. The Fiscal Year 2021 Omnibus Appropriations bill requires an additional $10 million be spent on Lyme disease research on top of the $53 million proposed by the NIH, which is the most funding provided for Lyme disease research in years.148 But while additional funding for research is instrumental to future diagnosis and treatment, and is long overdue, research funding does little to help patients currently suffering from chronic Lyme disease who continue to face high costs for treatment and insurance coverage denials.

This is an enormous national problem that we are refusing to address . . . . NIH has to get its act together

Senator Bill Bradley

The Cost of Limited Insurance Coverage

For patients, frequent outpatient visits and expensive medications contribute to the high cost of Lyme disease treatment, which is exacerbated by insurance claim denials. Direct medical costs for treatment of Lyme disease are estimated to be between $712 million and $1.3 billion a year in the U.S. From an individual cost perspective, patients with Lyme disease incur $2,968 more in medical expenses each year than the average insured person without Lyme disease and patients with one or more chronic symptom spend $3,798 more than Lyme patients without chronic symptoms. The high cost of treatment, particularly IV antibiotics, meant Lyme disease became a financial burden for insurance companies beginning in the 1990s. To alleviate the burden on the insurance companies’ bottom line, many companies began tightening requirements for proof of illness. For example, some began requiring patients to meet the CDC surveillance criteria before providing coverage, despite the CDC’s warning that its surveillance criteria should not be used for diagnosis due to its strict requirements.

Currently, patients are forced to incur treatment expenses because insurance companies pre-define what treatment is medically necessary. United Healthcare Oxford’s current clinical policy lists IV antibiotic treatment for Lyme disease as “not medically necessary” for patients with the policy’s defined Post-Treatment Lyme Disease Syndrome (PTLDS). It defines PTLDS as “Fatigue, [w]idespread musculoskeletal pain[, and c]omplaints of cognitive difficulties” if the symptoms persist more than six months after antibiotic treatment. Similarly, Aetna lists treatment for PTLDS as “experimental” and “investigational.” By defining treatment as “experimental” or “investigatory,” insurance companies narrowly craft definitions within their contracts and refuse to pay for treatment.

Patients do have some power to push back through internal appeals and civil lawsuits, but the process is costly and may require patients to wait for pre-authorization without treatment. Further, judges are often put in the position of determining medical necessity. Under the Employee Retirement Income Security Act (ERISA), for example, a patient can bring a civil suit after internal appeal for denial of benefits. However, leaving it up to the courts to decide whether a treatment is medically necessary can be ineffective, time consuming, and, for cases raised in different jurisdictions, inconsistent. With diseases such as Lyme that are still under considerable medical debate, courts may be forced to decide between one medical expert who deems the treatment experimental, and another who states the opposite. Meanwhile, the patient will continue to suffer symptoms, which can worsen over time without treatment. In Fuja v. Benefit Trust Life Insurance Co., a case about whether a certain breast cancer treatment could be denied insurance coverage because the treatment was pursued “in connection with medical or other research” the court stated:

[C]ases of this nature pose troubling social as well as ethical questions that go well beyond the legal issues. As a court of law[,] we are empowered to decide legal issues presented by specific cases. political branches of government which can engage in “legislative fact-finding” and “benefit from public hearings and constituent expression of opinion.”

Thus, some judges argue that the medical coverage debate is best left to the legislators instead of the courts.

Legislation offers the best hope for patients to receive reimbursement for their treatment from insurance companies. A law can uniformly prevent unfair denial of treatment based on poor scientific studies, such as Klempner’s study, and will remove the delay caused by the appeal process. Finally, federal legislation will reduce the burden on judges, who are currently forced to decide on social and ethical issues well outside the scope of legal issues.