PRINTER'S NO. 3710
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
2242
Session of
2015
INTRODUCED BY BAKER, PICKETT, MILLARD, STAATS, CORBIN, ROZZI,
TOEPEL, D. COSTA, JAMES, DRISCOLL, WARD, CAUSER, WATSON,
PASHINSKI, BARRAR, KAUFFMAN, METZGAR, MALONEY, TRUITT,
BOBACK, READSHAW, MAHONEY, HENNESSEY, HARHAI, MAJOR, McNEILL,
BRADFORD, SAYLOR, ZIMMERMAN, REGAN, DeLUCA, GILLEN, MILNE,
PHILLIPS-HILL, HEFFLEY AND LAWRENCE, JULY 7, 2016
REFERRED TO COMMITTEE ON HEALTH, JULY 7, 2016
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. Findings.
The General Assembly finds as follows:
(1) From 2002 to 2014, Pennsylvania reported a total of
59,478 confirmed cases of Lyme disease and in 2015 reported
10,817 new cases ranking highest in the nation in confirmed
cases for the last five years.
(2) In 2015, the Department of Environmental Protection
published a study that confirmed a high risk of Lyme disease
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in every county of the Commonwealth and that 67 counties had
the blacklegged tick.
(3) Early diagnosis and treatment of these tick-borne
illnesses and diseases can greatly reduce the risks of
continued symptoms which can affect every system and organ of
the human body and often every aspect of life.
(4) Between 10% to 40% of Lyme disease patients may go
on to suffer from a complex, chronic/persistent disease which
is much more difficult to treat.
(5) There are multiple diagnostic and treatment
guidelines for diagnosis and treatment of Lyme disease and
tick-borne illness; yet, in 2016, the National Guidelines
Clearinghouse (NGC) maintains only the International Lyme and
Associated Disease Society's (ILADS) guidelines, which
guidelines were updated in 2015 and met the more stringent
evidence criteria introduced by the NGC in 2014. These
guidelines recommend longer-term courses of antibiotics as an
option when deemed necessary by health care professionals.
The Infectious Disease Society of America's (IDSA) guidelines
were removed from the NGC in 2015 because they were "outdated
and not in compliance with current standards."
(6) A 2013 Centers for Disease Control and Prevention
(CDC) study found that only 39% of individuals with Lyme
disease were treated using short-term antibiotic
recommendations from the IDSA guidelines. The majority of the
individuals were treated for longer periods, more in line
with the ILADS recommendations.
(7) Scientific understanding of these complex tick-borne
illnesses is expected to evolve rapidly in the next decade,
including diagnosis and treatment options.
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Section 3. 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:
"Health care practitioner." A 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, who is
authorized to prescribe medication in this Commonwealth.
"Health insurance policy."
(1) Any individual or group health, sickness or accident
policy, or subscriber contract or certificate offered, issued
or renewed by an entity subject to one of the following:
(i) This act.
(ii) The act of December 29, 1972 (P.L.1701,
No.364), known as the Health Maintenance Organization
Act.
(iii) The provisions of 40 Pa.C.S. Ch. 61 (relating
to hospital plan corporations) or 63 (relating to
professional health services plan corporations).
(2) The term does not include accident only, fixed
indemnity, limited benefit, credit, dental, vision, specified
disease, Medicare supplement, Civilian Health and Medical
Program of the Uniformed Services (CHAMPUS) supplement, long-
term care or disability income, workers' compensation or
automobile medical payment insurance.
"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, that are
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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.
Section 4. Legislative intent.
It is the intent of the General Assembly to ensure that
patients have access to available and emerging diagnostics and
treatment options for Lyme disease and related tick-borne
illnesses as prescribed by health care practitioners.
Section 5. Treatment.
A health care practitioner may order diagnostic testing and
prescribe, administer or dispense antibiotic therapy of the
duration they determine 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 by documenting the
diagnosis and treatment in the patient's medical records.
Section 6. Coverage requirement.
The following apply:
(1) Every health insurance policy which is delivered,
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issued for delivery, renewed, extended or modified in this
Commonwealth shall cover the prescribed treatment 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, as prescribed by
the patient's attending health care practitioner.
(2) Longer-term antibiotic treatment shall not be
denied coverage solely because the treatment may be
characterized as unproven, experimental or investigational in
nature for the treatment of Lyme disease and related tick-
borne illnesses.
Section 7. Immunity.
(a) General rule.--No health care practitioner shall be
subject to disciplinary action by the health care
practitioner's licensing board solely for diagnosing Lyme
disease or related tick-borne illnesses or for prescribing,
administering or dispensing longer-term antibiotic therapies for
the therapeutic purpose of eliminating infection or controlling
a patient's symptoms when the patient is clinically diagnosed
with Lyme disease or related tick-borne illnesses, if the
diagnosis, treatment plan and ongoing monitoring has been
documented in the patient's medical record.
(b) Construction.--Nothing in this section shall be
construed to deny the right of a licensing board to deny, revoke
or suspend the license of or to discipline any health care
practitioner who:
(1) prescribes, administers or dispenses longer-term
antibiotic therapy for a nontherapeutic purpose;
(2) fails to monitor ongoing care of a patient receiving
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longer-term antibiotics; or
(3) fails to keep complete and accurate records of the
diagnosis, treatment and response to treatment of a patient
receiving longer-term treatment relating to Lyme disease or
related tick-borne illnesses.
Section 8. Effective date.
This act shall take effect in 60 days.
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