SB 461 — 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.

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
 1   Providing for patient access to diagnostics and treatments for
 2      Lyme disease and related tick-borne illnesses; and requiring
 3      health care policies to provide certain coverage.
 4      The General Assembly of the Commonwealth of Pennsylvania
 5   hereby enacts as follows:
 6   Section 1.   Short title.
 7      This act shall be known and may be cited as the Lyme Disease
 8   and Related Tick-Borne Illness Diagnosis and Treatment Act.
 9   Section 2.   Legislative findings.
10      The General Assembly finds as follows:
11          (1)   This Commonwealth has the highest incidence of Lyme
12      disease in the country in 10 of the past 11 years. Each year,
13      approximately 100,000 Pennsylvanians get Lyme disease.
14          (2)   In 2018, there were 102,080 confirmed and probable
15      Lyme disease cases reported in this Commonwealth, which
16      represents 30.32% of all cases in the United States. This is
17      an incidence rate of 70.3 per 100,000 confirmed and probable
18      cases in 2019.
 1        (3)   From 2010 to 2019, there have been more than 66,144
 2    confirmed Lyme disease cases in this Commonwealth, but due to
 3    the fact that the Centers for Disease Control and
 4    Prevention's number only represents confirmed cases, the
 5    estimated number of Lyme disease cases are 661,440 based on
 6    the Centers for Disease Control and Prevention's 10 times
 7    multiplier of actual cases. Therefore, with more than
 8    12,960,000 Pennsylvanians in 2019, an estimated 5.1% of
 9    Pennsylvanians contracted Lyme disease in the same 10 years.
10        (4)   In July 2021, the Department of Environmental
11    Protection, the Department of Conservation and Natural
12    Resources and the Physician General discussed the high
13    incidence in this Commonwealth resulting in high prevalence
14    of ticks and confirmed a high risk of Lyme disease in every
15    county of this Commonwealth. The Department of Environmental
16    Protection collected two times more blacklegged tick nymphs
17    in 2021 compared to 2020 and stated that infected blacklegged
18    ticks are present in all 67 counties in this Commonwealth.
19        (5)   According to the Centers for Disease Control and
20    Prevention, Lyme disease is the most common vector-borne
21    disease in the United States.
22        (6)   The early clinical diagnosis and appropriate
23    treatment of these related tick-borne illnesses can greatly
24    reduce the risks of continued, diverse and chronic symptoms
25    that can affect every system and organ of the human body and
26    often every aspect of an individual's life.
27        (7)   Between 10% to 40% of Lyme disease patients may go
28    on to suffer from complex, chronic/persistent conditions
29    which may be more difficult to treat.
30        (8)   There are multiple diagnostic and treatment

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 1      guidelines for diagnosis and treatment of Lyme disease and
 2      related tick-borne illness.
 3          (9)    Scientific understanding of these complex related
 4      tick-borne illnesses is expected to evolve rapidly in the
 5      next decade, including prevention, diagnosis and treatment
 6      options.
 7          (10)    A 2013 Centers for Disease Control and Prevention
 8      study found that only 39% of individuals with Lyme disease
 9      were treated using short-term antibiotics. The majority of
10      the individuals were treated for longer periods.
11          (11)    In 2014, the Massachusetts Center for Health and
12      Information Analysis found little to no increase in insurance
13      costs as a result of expanding coverage to include longer-
14      term courses of antibiotics. The expansion by fully insured
15      health plans was projected to result in an average annual
16      increase, over five years, to the typical member's monthly
17      health insurance premiums of between a negligible amount and
18      13¢ per year.
19   Section 3.    Legislative purpose.
20      The purposes of this act are:
21          (1)    To promote the education and awareness of Lyme
22      disease and related tick-borne illnesses among health care
23      practitioners.
24          (2)    To substantially reduce the incidence of related
25      tick-borne illnesses by providing insurance coverage for
26      diagnostic testing and treatment.
27          (3)    To eliminate or, at the very least, significantly
28      reduce the number of confirmed Lyme disease cases and related
29      tick-borne illnesses in this Commonwealth.
30          (4)    To promote the availability of tick testing to aid

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 1      in determining a clinical diagnosis.
 2          (5)   To promote the availability of diagnostic testing
 3      and antibiotic therapies for patients by licensed health care
 4      practitioners.
 5          (6)   To improve public awareness of Lyme disease and
 6      related tick-borne illnesses and educate the public about
 7      tick bite prevention practices that can reduce the incidence
 8      and prevalence of ticks in this Commonwealth.
 9   Section 4.   Definitions.
10      The following words and phrases when used in this act shall
11   have the meanings given to them in this section unless the
12   context clearly indicates otherwise:
13      "Clinical diagnosis."     A diagnosis of a patient based
14   primarily on information obtained from medical history, a
15   physical examination of the patient and review of medical
16   records, including laboratory tests and radiologic studies or
17   other differential diagnostic testing.
18      "Covered person."   A policyholder, subscriber or other
19   individual who is entitled to receive health care services under
20   a health insurance policy.
21      "Department."    The Department of Health of the Commonwealth.
22      "Enrollee."   An individual who is entitled to receive health
23   care services under an agreement with the Department of Human
24   Services.
25      "Government program."     Either of the following:
26          (1)   The medical assistance program established under the
27      act of June 13, 1967 (P.L.31, No.21), known as the Human
28      Services Code.
29          (2)   The children's health insurance program established
30      under Article XXIII-A of the act of May 17, 1921 (P.L.682,

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 1      No.284), known as The Insurance Company Law of 1921.
 2      "Health care practitioner."     As defined in section 103 of the
 3   act of July 19, 1979 (P.L.130, No.48), known as the Health Care
 4   Facilities Act.
 5      "Health insurance policy."     An individual or group insurance
 6   policy, subscriber contract, certificate or plan issued by an
 7   insurer that provides medical or health care coverage, including
 8   emergency services. The term does not include:
 9          (1)     An accident only policy.
10          (2)     A credit only policy.
11          (3)     A long-term care or disability income policy.
12          (4)     A specified disease policy.
13          (5)     A Medicare supplement policy.
14          (6)     A TRICARE policy, including a Civilian Health and
15      Medical Program of the Uniformed Services (CHAMPUS)
16      supplement policy.
17          (7)     A fixed indemnity policy.
18          (8)     A hospital indemnity policy.
19          (9)     A dental only policy.
20          (10)     A vision only policy.
21          (11)     A workers' compensation policy.
22          (12)     An automobile medical payment policy.
23          (13)     A homeowners' insurance policy.
24          (14)     A short-term limited duration policy.
25          (15)     Any other similar policy providing for limited
26      benefits.
27      "Insurer."     An entity licensed by the Insurance Department
28   with accident and health authority to issue a health insurance
29   policy that is offered or governed under any of the following:
30          (1)     The Insurance Company Law of 1921, including section

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 1      630 and Article XXIV.
 2          (2)   The act of December 29, 1972 (P.L.1701, No.364),
 3      known as the Health Maintenance Organization Act.
 4          (3)   40 Pa.C.S. Ch. 61 (relating to hospital plan
 5      corporations) or 63 (relating to professional health services
 6      plan corporations).
 7      "Lyme disease."   Signs or symptoms compatible with acute,
 8   late-stage, persistent infection with Borrelia burgdorferi or
 9   complications related to such infection or with such other
10   strains of Borrelia, including, but not limited to, B.
11   miyamotoi, B. mayonii, B. garinii and B. afzelii, that are
12   recognized by the Centers for Disease Control and Prevention as
13   a cause of Lyme disease. The term includes infection that meets
14   the surveillance criteria established by the Centers for Disease
15   Control and Prevention and other acute and persistent
16   manifestations of such an infection as determined by a health
17   care practitioner.
18      "Related tick-borne illness."      The presence of signs or
19   symptoms compatible with infection with bartonella,
20   babesiosis/piroplasmosis, anaplasmosis, ehrlichiosis, Rocky
21   Mountain spotted fever, rickettsiosis or other tick-
22   transmissible illness or complications related to the
23   infections. The term does not include Lyme disease.
24      "Surveillance criteria."   The set of case definition
25   standards established by the Centers for Disease Control and
26   Prevention for the purposes of consistency in research or for
27   evaluating trends in the spread of various diseases, but which
28   the Centers for Disease Control and Prevention does not intend
29   to be used by health care practitioners for individual patient
30   diagnoses.

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 1   Section 5.     Treatment.
 2      If a health care practitioner orders diagnostic testing then
 3   prescribes, administers or dispenses antibiotic therapy that the
 4   licensed health care practitioner determines appropriate for the
 5   patient, for the therapeutic purpose of eliminating or
 6   controlling a patient's infection or symptoms upon making a
 7   clinical diagnosis that the patient has Lyme disease or a
 8   related tick-borne illness or displays symptoms consistent with
 9   a clinical diagnosis of Lyme disease or related tick-borne
10   illnesses, and documents the diagnosis and treatment in the
11   patient's medical records, the attending health care
12   practitioner shall consult and report to the Statewide registry
13   under section 6(c) the clinical diagnosis.
14   Section 6.     Duties of department.
15      (a)   Comprehensive educational program.--The department shall
16   conduct an annual public information campaign to inform each
17   licensed physician, physician's assistant, certified registered
18   nurse and other health care practitioners of the requirements of
19   this act.
20      (b)   Distribution of literature about Lyme disease and
21   related tick-borne illnesses.--The department shall provide
22   educational material in accordance with the following:
23            (1)   The department shall provide culturally and
24      linguistically appropriate educational materials regarding
25      Lyme disease and related tick-borne illnesses, prevention of
26      disease and illness, treatment for disease and illness,
27      surveillance research and, when appropriate, the requirements
28      of this act.
29            (2)   Educational materials shall be available at no cost
30      and shall be developed for specific audiences, including

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 1      health care practitioners, patients and the general public.
 2      (c)   Statewide registry.--The department shall partner with
 3   the Tick Research Lab of Pennsylvania at East Stroudsburg
 4   University, or a successor testing facility at a successor or
 5   other college or university, to develop an electronic database
 6   for use by the Tick Research Lab, the department and health care
 7   practitioners. The database shall include the following
 8   nonidentifiable patient information submitted to the department:
 9            (1)   From the Tick Research Lab of Pennsylvania, tick
10      testing information, including the results of the testing and
11      the zip code and county location of where the tick was
12      extracted.
13            (2)   From the health care practitioner, information,
14      including diagnostic testing information and testing results,
15      confirmed or suspected diagnosis and surveillance criteria
16      applied to determine the confirmed or suspected diagnosis.
17   Section 7.     Lyme Disease Testing Coverage.
18      (a)   Insurance or program coverage.--A health insurance
19   policy or government program shall provide to covered persons or
20   enrollees who are seeking treatment in accordance with section 5
21   for Lyme disease or related tick-borne illness the following
22   coverage when ordered by the covered person's or enrollee's
23   health care practitioner:
24            (1)   All diagnostic testing. This includes testing of all
25      bands on the western blot test for the purposes of a clinical
26      diagnosis and determining appropriate treatment.
27            (2)   Tick testing.
28            (3)   The prescribed treatment for Lyme disease or related
29      tick-borne illnesses if the clinical diagnosis and treatment
30      plan are documented in the covered person's or enrollee's

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 1      medical record. Treatment plans may include short-term or
 2      long-term durations of antibiotic or antimicrobial
 3      treatments, including both oral or intravenous, as prescribed
 4      by the covered person's or enrollee's attending health care
 5      practitioner.
 6      (b)   Copayments, deductibles and coinsurance.--Coverage under
 7   this section shall be subject to copayment, deductible and
 8   coinsurance provisions and any other general exclusions or
 9   limitations of a health insurance policy or government program
10   to the same extent as other medical services covered by the
11   health insurance policy or government program are subject to
12   these provisions.
13      (c)   Construction.--This section does not limit benefits
14   which are otherwise available to an individual under a health
15   insurance policy or government program.
16      (d)   Report by insurers.--By January 1, 2027, an insurer
17   shall make a report to the Insurance Department, in a form and
18   manner as determined by the department, to evaluate the
19   implementation of this section.
20   Section 8.     Application.
21      Section 7 shall apply as follows:
22            (1)   For health insurance policies for which either rates
23      or forms are required to be filed with the Federal Insurance
24      Office, this act shall apply to any health insurance policy
25      for which a form or rate is first filed on or after the
26      effective date of this section.
27            (2)   For health insurance policies for which neither
28      rates nor forms are required to be filed with the Federal
29      Insurance Office, this act shall apply to any health
30      insurance policy offered, issued or renewed on or after 180

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1      days after the effective date of this section.
2   Section 9.    Regulations.
3      The department shall adopt rules and promulgate regulations
4   to administer and enforce this act.
5   Section 10.    Effective date.
6      This act shall take effect in 60 days.




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