PRINTER'S NO. 414 THE GENERAL ASSEMBLY OF PENNSYLVANIA SENATE BILL No.461 Session of 2025 INTRODUCED BY BROOKS, COLLETT, FONTANA, SANTARSIERO, LANGERHOLC, CULVER, COSTA, COMITTA, KANE, J. WARD AND L. WILLIAMS, MARCH 17, 2025 REFERRED TO HEALTH AND HUMAN SERVICES, MARCH 17, 2025 AN ACT Providing for patient access to diagnostics and treatments for Lyme disease and related tick-borne illnesses; and requiring health care policies to provide certain coverage. The General Assembly of the Commonwealth of Pennsylvania hereby enacts as follows: Section 1. Short title. This act shall be known and may be cited as the Lyme Disease and Related Tick-Borne Illness Diagnosis and Treatment Act. Section 2. Legislative findings. The General Assembly finds as follows: (1) This Commonwealth has the highest incidence of Lyme disease in the country in 10 of the past 11 years. Each year, approximately 100,000 Pennsylvanians get Lyme disease. (2) In 2018, there were 102,080 confirmed and probable Lyme disease cases reported in this Commonwealth, which represents 30.32% of all cases in the United States. This is an incidence rate of 70.3 per 100,000 confirmed and probable cases in 2019. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 (3) From 2010 to 2019, there have been more than 66,144 confirmed Lyme disease cases in this Commonwealth, but due to the fact that the Centers for Disease Control and Prevention's number only represents confirmed cases, the estimated number of Lyme disease cases are 661,440 based on the Centers for Disease Control and Prevention's 10 times multiplier of actual cases. Therefore, with more than 12,960,000 Pennsylvanians in 2019, an estimated 5.1% of Pennsylvanians contracted Lyme disease in the same 10 years. (4) In July 2021, the Department of Environmental Protection, the Department of Conservation and Natural Resources and the Physician General discussed the high incidence in this Commonwealth resulting in high prevalence of ticks and confirmed a high risk of Lyme disease in every county of this Commonwealth. The Department of Environmental Protection collected two times more blacklegged tick nymphs in 2021 compared to 2020 and stated that infected blacklegged ticks are present in all 67 counties in this Commonwealth. (5) According to the Centers for Disease Control and Prevention, Lyme disease is the most common vector-borne disease in the United States. (6) The early clinical diagnosis and appropriate treatment of these related tick-borne illnesses can greatly reduce the risks of continued, diverse and chronic symptoms that can affect every system and organ of the human body and often every aspect of an individual's life. (7) Between 10% to 40% of Lyme disease patients may go on to suffer from complex, chronic/persistent conditions which may be more difficult to treat. (8) There are multiple diagnostic and treatment 20250SB0461PN0414 - 2 - 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 guidelines for diagnosis and treatment of Lyme disease and related tick-borne illness. (9) Scientific understanding of these complex related tick-borne illnesses is expected to evolve rapidly in the next decade, including prevention, diagnosis and treatment options. (10) A 2013 Centers for Disease Control and Prevention study found that only 39% of individuals with Lyme disease were treated using short-term antibiotics. The majority of the individuals were treated for longer periods. (11) In 2014, the Massachusetts Center for Health and Information Analysis found little to no increase in insurance costs as a result of expanding coverage to include longer- term courses of antibiotics. The expansion by fully insured health plans was projected to result in an average annual increase, over five years, to the typical member's monthly health insurance premiums of between a negligible amount and 13ยข per year. Section 3. Legislative purpose. The purposes of this act are: (1) To promote the education and awareness of Lyme disease and related tick-borne illnesses among health care practitioners. (2) To substantially reduce the incidence of related tick-borne illnesses by providing insurance coverage for diagnostic testing and treatment. (3) To eliminate or, at the very least, significantly reduce the number of confirmed Lyme disease cases and related tick-borne illnesses in this Commonwealth. (4) To promote the availability of tick testing to aid 20250SB0461PN0414 - 3 - 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 in determining a clinical diagnosis. (5) To promote the availability of diagnostic testing and antibiotic therapies for patients by licensed health care practitioners. (6) To improve public awareness of Lyme disease and related tick-borne illnesses and educate the public about tick bite prevention practices that can reduce the incidence and prevalence of ticks in this Commonwealth. Section 4. Definitions. The following words and phrases when used in this act shall have the meanings given to them in this section unless the context clearly indicates otherwise: "Clinical diagnosis." A diagnosis of a patient based primarily on information obtained from medical history, a physical examination of the patient and review of medical records, including laboratory tests and radiologic studies or other differential diagnostic testing. "Covered person." A policyholder, subscriber or other individual who is entitled to receive health care services under a health insurance policy. "Department." The Department of Health of the Commonwealth. "Enrollee." An individual who is entitled to receive health care services under an agreement with the Department of Human Services. "Government program." Either of the following: (1) The medical assistance program established under the act of June 13, 1967 (P.L.31, No.21), known as the Human Services Code. (2) The children's health insurance program established under Article XXIII-A of the act of May 17, 1921 (P.L.682, 20250SB0461PN0414 - 4 - 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 No.284), known as The Insurance Company Law of 1921. "Health care practitioner." As defined in section 103 of the act of July 19, 1979 (P.L.130, No.48), known as the Health Care Facilities Act. "Health insurance policy." An individual or group insurance policy, subscriber contract, certificate or plan issued by an insurer that provides medical or health care coverage, including emergency services. The term does not include: (1) An accident only policy. (2) A credit only policy. (3) A long-term care or disability income policy. (4) A specified disease policy. (5) A Medicare supplement policy. (6) A TRICARE policy, including a Civilian Health and Medical Program of the Uniformed Services (CHAMPUS) supplement policy. (7) A fixed indemnity policy. (8) A hospital indemnity policy. (9) A dental only policy. (10) A vision only policy. (11) A workers' compensation policy. (12) An automobile medical payment policy. (13) A homeowners' insurance policy. (14) A short-term limited duration policy. (15) Any other similar policy providing for limited benefits. "Insurer." An entity licensed by the Insurance Department with accident and health authority to issue a health insurance policy that is offered or governed under any of the following: (1) The Insurance Company Law of 1921, including section 20250SB0461PN0414 - 5 - 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 630 and Article XXIV. (2) The act of December 29, 1972 (P.L.1701, No.364), known as the Health Maintenance Organization Act. (3) 40 Pa.C.S. Ch. 61 (relating to hospital plan corporations) or 63 (relating to professional health services plan corporations). "Lyme disease." Signs or symptoms compatible with acute, late-stage, persistent infection with Borrelia burgdorferi or complications related to such infection or with such other strains of Borrelia, including, but not limited to, B. miyamotoi, B. mayonii, B. garinii and B. afzelii, th at are recognized by the Centers for Disease Control and Prevention as a cause of Lyme disease. The term includes infection that meets the surveillance criteria established by the Centers for Disease Control and Prevention and other acute and persistent manifestations of such an infection as determined by a health care practitioner. "Related tick-borne illness." The presence of signs or symptoms compatible with infection with bartonella, babesiosis/piroplasmosis, anaplasmosis, ehrlichiosis, Rocky Mountain spotted fever, rickettsiosis or other tick- transmissible illness or complications related to the infections. The term does not include Lyme disease. "Surveillance criteria." The set of case definition standards established by the Centers for Disease Control and Prevention for the purposes of consistency in research or for evaluating trends in the spread of various diseases, but which the Centers for Disease Control and Prevention does not intend to be used by health care practitioners for individual patient diagnoses. 20250SB0461PN0414 - 6 - 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 Section 5. Treatment. If a health care practitioner orders diagnostic testing then prescribes, administers or dispenses antibiotic therapy that the licensed health care practitioner determines appropriate for the patient, for the therapeutic purpose of eliminating or controlling a patient's infection or symptoms upon making a clinical diagnosis that the patient has Lyme disease or a related tick-borne illness or displays symptoms consistent with a clinical diagnosis of Lyme disease or related tick-borne illnesses, and documents the diagnosis and treatment in the patient's medical records, the attending health care practitioner shall consult and report to the Statewide registry under section 6(c) the clinical diagnosis. Section 6. Duties of department. (a) Comprehensive educational program.--The department shall conduct an annual public information campaign to inform each licensed physician, physician's assistant, certified registered nurse and other health care practitioners of the requirements of this act. (b) Distribution of literature about Lyme disease and related tick-borne illnesses.--The department shall provide educational material in accordance with the following: (1) The department shall provide culturally and linguistically appropriate educational materials regarding Lyme disease and related tick-borne illnesses, prevention of disease and illness, treatment for disease and illness, surveillance research and, when appropriate, the requirements of this act. (2) Educational materials shall be available at no cost and shall be developed for specific audiences, including 20250SB0461PN0414 - 7 - 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 health care practitioners, patients and the general public. (c) Statewide registry.--The department shall partner with the Tick Research Lab of Pennsylvania at East Stroudsburg University, or a successor testing facility at a successor or other college or university, to develop an electronic database for use by the Tick Research Lab, the department and health care practitioners. The database shall include the following nonidentifiable patient information submitted to the department: (1) From the Tick Research Lab of Pennsylvania, tick testing information, including the results of the testing and the zip code and county location of where the tick was extracted. (2) From the health care practitioner, information, including diagnostic testing information and testing results, confirmed or suspected diagnosis and surveillance criteria applied to determine the confirmed or suspected diagnosis. Section 7. Lyme Disease Testing Coverage. (a) Insurance or program coverage.--A health insurance policy or government program shall provide to covered persons or enrollees who are seeking treatment in accordance with section 5 for Lyme disease or related tick-borne illness the following coverage when ordered by the covered person's or enrollee's health care practitioner: (1) All diagnostic testing. This includes testing of all bands on the western blot test for the purposes of a clinical diagnosis and determining appropriate treatment. (2) Tick testing. (3) The prescribed treatment for Lyme disease or related tick-borne illnesses if the clinical diagnosis and treatment plan are documented in the covered person's or enrollee's 20250SB0461PN0414 - 8 - 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 medical record. Treatment plans may include short-term or long-term durations of antibiotic or antimicrobial treatments, including both oral or intravenous, as prescribed by the covered person's or enrollee's attending health care practitioner. (b) Copayments, deductibles and coinsurance.--Coverage under this section shall be subject to copayment, deductible and coinsurance provisions and any other general exclusions or limitations of a health insurance policy or government program to the same extent as other medical services covered by the health insurance policy or government program are subject to these provisions. (c) Construction.--This section does not limit benefits which are otherwise available to an individual under a health insurance policy or government program. (d) Report by insurers.--By January 1, 2027, an insurer shall make a report to the Insurance Department, in a form and manner as determined by the department, to evaluate the implementation of this section. Section 8. Application. Section 7 shall apply as follows: (1) For health insurance policies for which either rates or forms are required to be filed with the Federal Insurance Office, this act shall apply to any health insurance policy for which a form or rate is first filed on or after the effective date of this section. (2) For health insurance policies for which neither rates nor forms are required to be filed with the Federal Insurance Office, this act shall apply to any health insurance policy offered, issued or renewed on or after 180 20250SB0461PN0414 - 9 - 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 days after the effective date of this section. Section 9. Regulations. The department shall adopt rules and promulgate regulations to administer and enforce this act. Section 10. Effective date. This act shall take effect in 60 days. 20250SB0461PN0414 - 10 - 1 2 3 4 5 6