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Senate of Pennsylvania
Session of 2017 - 2018 Regular Session


Posted: December 5, 2016 12:51 PM
From: Senator Stewart J. Greenleaf
To: All Senate members
Subject: Insurance Coverage for Lyme Disease and Related Tick-Borne Illnesses
I am reintroducing Senate Bill 1299, legislation enacting the Lyme and Related Tick-Borne Disease Diagnosis and Treatment Act. The intent of the legislation is to ensure that patients have access to available and emerging diagnostics and treatment options for Lyme disease and related tick-borne diseases as prescribed by the attending health care professional.

Two schools of thought (standards of care) exist today regarding the diagnosis and treatment of Lyme disease. The Infectious Disease Society of America’s (IDSA) guidelines, which most insurers apply for coverage decisions, provides for short-term antibiotic treatment, regardless of continuation of symptoms. The International Lyme and Associated Disease Society (ILADS) guidelines provide for longer term treatment with antibiotic therapies for persistent and chronic Lyme disease symptoms not cured by short term protocols. Both guidelines are evidence-based. The National Guidelines Clearinghouse (NGC) currently provides only the ILADS guidelines on their website. These were updated and republished by the NGC in 2015. The IDSA Guidelines were removed by the NGC as they were outdated, and no longer met the NGC’s current evidence requirements. The IDSA has indicated it will take 2-5 years before their guidelines are updated (2018-2021). This leaves the ILADS guidelines the only NGC recommended guidelines for the diagnosis and treatment of Lyme and Related diseases. And yet, insurers in Pennsylvania continue to deny longer-term antibiotic treatments prescribed by physicians. Insurers should be covering both approaches as long as the treating physician informs the patient of all treatment options, risks and benefits, and the patient consents.

A 2013 CDC study found that only 39% of those with Lyme disease were treated using short term antibiotic recommendations from the IDSA guidelines. The majority were treated for longer periods, more in line with the ILADS recommendations. Scientific understanding of these complex tick-borne diseases will continue to evolve rapidly in the next decade, including diagnosis and treatment options. Patients should be fully informed of their options, taking into account the best scientific evidence available, the physician’s clinical judgment, and, in light of the patient’s values and preferences, be informed to make the best decision for themselves.

Under the bill, health insurers would be required to cover the treatment as prescribed by their health care practitioner for Lyme disease or related tick-borne illnesses if the diagnosis and treatment plan are documented in the patient's medical record. Treatment plans may include short or longer durations of antibiotic or antimicrobial treatments. Longer-term antibiotic treatment shall not be denied coverage solely because such treatment may be characterized as unproven, experimental, or investigational in nature for the treatment of Lyme and related tick-borne diseases.

The legislation provides that health care professionals have the right to diagnose and prescribe antibiotic therapy for a duration they deem appropriate for the patient upon making a clinical diagnosis of Lyme disease or related tick-borne disease. In addition, no health care professional shall be subject to disciplinary action by their licensing board solely for prescribing longer-term antibiotic therapies for a therapeutic purpose for a patient with Lyme disease or related tick-borne illness. However, the licensing board retains appropriate monitoring powers to ensure patient safety. Similar language has been approved in other states ((RI, NY, MN, CT, MA, NJ, VT)) that protects health care professionals from such actions, and also to diffuse the “chilling effect” such sanctions have had on physicians in diagnosis and treatment of Lyme disease.

To date, multiple states (RI, NY, MN, CT, MA, NJ, VT) have enacted laws, or have legislation pending, which require insurance coverage for longer-term antibiotic treatment of Lyme disease, and/or acknowledge the legitimacy of longer-term antibiotic treatments as an option if deemed medically necessary and prescribed by their physicians. In July, the Massachusetts Legislature approved a bill requiring private health insurers to provide coverage for long-term antibiotic therapy for a patient with Lyme disease when determined to be medically necessary and ordered by a physician. With regard to Rhode Island, a sunset provision was incorporated into its 2003 law so its impact could be evaluated. A year later the Legislature removed the sunset date to permanently require health insurers in Rhode Island to cover antibiotics as a treatment for Lyme disease. A 2013 review of Mandated Benefits by the Rhode Island Office of Health Insurance Commissioner estimates that the impact of this mandate on premiums to be $0.03 per member per month. In 2014, the Massachusetts Center for Health and Information Analysis reviewed proposed legislation mandating insurers to cover long-term antibiotic treatment of Lyme disease, finding an average annual increase, over five years, to typical member’s monthly health insurance premiums between a negligible amount (0.00%) and $0.13 (0.02%) per year.

Pennsylvania has ranked highest in the nation in confirmed cases of Lyme disease for five years running. From 2002 to 2014, Pennsylvania reported a total of 59,478 confirmed cases of Lyme disease and in 2015 reported 10,817 new cases. Notably, 2016 cases are likely to again surpass 2015 with 11,271 cases reported YTD (a/o 11/26/16) compared to 8,638 YTD 2015 (11/28/15). The CDC indicates under-reporting at a factor of 10, making new cases in Pennsylvania actually 100,817. There is no county in Pennsylvania without Lyme disease. A PA Department of Environmental Protection study was published in 2015 confirming a high risk of Lyme in every county of the Commonwealth (67 counties had the black legged tick).

Introduced as SB100