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PRINTER'S NO. 1877
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No.
1299
Session of
2015
INTRODUCED BY GREENLEAF, SCAVELLO, ARGALL, TEPLITZ, WOZNIAK,
RAFFERTY, COSTA, TARTAGLIONE, AUMENT, BAKER, McGARRIGLE AND
BOSCOLA, JUNE 6, 2016
REFERRED TO BANKING AND INSURANCE, JUNE 6, 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 (provisional cases to be confirmed in 2016),
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
in every county of the Commonwealth and that 67 counties had
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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were removed from the NGC in 2015 because they were "outdated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 International Lyme and Associated Disease Society's
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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(8) The exercise of the patient's right of self-
determination is a cornerstone of medical ethics, endorsed by
the American Medical Association, American College of
Physicians and other professional medical organizations.
Patients should be fully informed of their options, taking
into account the best scientific evidence available,
especially in emerging diseases, and the physician's clinical
judgment and, in light of the patient's values and
preferences, patients should be informed in order to make the
best decision for themselves.
(9) In 2014, the Massachusetts Center for Health and
Information Analysis (CHIA) 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 $0.13 per year.
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:
"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.
"Health care professional." A licensed physician,
physician's assistant, certified registered nurse practitioner
or other licensed health care professional.
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"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
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 professional.
"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 professionals for individual patient
diagnoses.
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 attending health care professionals.
Section 5. Treatment.
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A licensed health care professional 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. Required coverage.
(a) Duty to provide.--
(1) Except as provided in subsection (b), every health
care policy which is delivered, issued for delivery, renewed,
extended or modified in this Commonwealth by a health insurer
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 professional.
(2) Longer-term antibiotic treatment otherwise eligible
for benefits under this section 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.
(b) Exception.--Subsection (a) shall not apply to any of the
following types of insurance:
(1) Hospital indemnity.
(2) Accident.
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(3) Specified disease.
(4) Disability income.
(5) Dental.
(6) Vision.
(7) Medicare and Medicare Advantage.
(8) Any federally funded plans, including TRICARE,
formerly CHAMPUS, covering military personnel and dependents,
Veterans Administration and the Federal Employee's Health
Benefit Plan.
(9) Self-insured plans, subject to Federal law.
(10) Other limited insurance benefit plans.
Section 7. Immunity.
(a) General rule.--No health care professional may be
subject to disciplinary action by the health care professional'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
professional who:
(1) prescribes, administers or dispenses longer-term
antibiotic therapy for a nontherapeutic purpose;
(2) fails to monitor ongoing care of a patient receiving
longer-term antibiotics; or
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(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 immediately.
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