A00669
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
629
Session of
2019
INTRODUCED BY RAPP, KAUFFMAN, BOROWICZ, HERSHEY, OWLETT,
ZIMMERMAN, SAYLOR, REESE, ROTHMAN, GLEIM, STRUZZI, HARKINS,
MURT, STURLA, QUINN, READSHAW, T. DAVIS, JAMES, STAATS,
PEIFER, BARRAR, McNEILL, D. MILLER, JOZWIAK, FREEMAN, BOBACK,
MACKENZIE, OTTEN, DeLUCA, CAUSER, PICKETT, LAWRENCE,
B. MILLER, GILLEN, GABLER, MASSER, ECKER, RAVENSTAHL,
HANBIDGE, MILLARD, EVERETT, EMRICK AND FRITZ,
FEBRUARY 28, 2019
AS REPORTED FROM COMMITTEE ON HEALTH, HOUSE OF REPRESENTATIVES,
AS AMENDED, MARCH 25, 2019
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 1990 to 2017, Pennsylvania reported 79,283
116,824 confirmed cases of Lyme disease and in 2017 reported
10,001 11,900 new cases, ranking highest in the nation in
confirmed cases for the last seven years. BECAUSE THE UNITED
STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR
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DISEASE CONTROL AND PREVENTION ESTIMATES CASES MAY BE
UNDERREPORTED BY A FACTOR OF 10, IT IS ESTIMATED THAT THE
NUMBER OF LYME DISEASE CASES IN PENNSYLVANIA IN 2017 WAS
CLOSER TO 119,000.
(2) In 2015, the Department of Environmental Protection
published a study that confirmed a high risk of Lyme disease
in every county of this Commonwealth and noted 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
conditions which is much may be 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 Guideline
Clearinghouse (NGC) maintains only the International Lyme and
Associated Diseases 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 Diseases 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
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disease were treated using short-term antibiotic
recommendations from the IDSA guidelines ANTIBIOTICS. 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.
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) An 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) The act of May 17, 1921 (P.L.682, No.284), known
as The Insurance Company Law of 1921, INCLUDING SECTION
630 AND ARTICLE XXIV OF THE 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
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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 the infection or with 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 the
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. Treatment.
(a) Options.--A health care practitioner may order
diagnostic testing and prescribe, administer or dispense
antibiotic therapy for the duration the health care practitioner
determines appropriate for a 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 illness. The health care practitioner must
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document the diagnosis and treatment in the patient's medical
records.
(b) Required disclosure.--A health care practitioner shall
fully disclose all risks and benefits associated with any
recommended treatment option. The disclosure shall include
alternatives that a reasonable prudent patient would require to
make an informed decision. The disclosure of the information
under this subsection shall be recorded in the patient's medical
record.
Section 5. Coverage requirement.
The following apply:
(1) Every health insurance policy which is delivered,
issued for delivery, renewed, extended or modified in this
Commonwealth shall cover the prescribed treatment for Lyme
disease and 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) Coverage of longer-term antibiotic treatment shall
MAY not be denied 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. provide coverage for long-term antibiotic
and antimicrobial therapy for a patient with Lyme disease and
related tick-borne illnesses when determined by a health care
practitioner to be medically necessary and ordered by a
health care practitioner after making a thorough evaluation
of the patient's symptoms, diagnostic test results or
response to treatment.
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(2) Nothing in this section shall be construed as
limiting a health insurer's ability to use utilization
management tools.
Section 6. Immunity Licensing authority.
(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 a related tick-borne illness, 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 a related tick-borne illness if the
diagnosis, treatment plan and ongoing monitoring has been
documented in the patient's medical record. and recommending a
treatment protocol which the health care practitioner deems
medically necessary based on the patient's needs and responses
to other clinical measures.
(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
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 antibiotic treatment relating to Lyme
disease or a related tick-borne illness.
SECTION 7. APPLICABILITY.
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(A) HEALTH INSURANCE POLICIES.--THIS ACT SHALL APPLY TO
HEALTH INSURANCE POLICIES AS FOLLOWS:
(1) FOR A HEALTH INSURANCE POLICY FOR WHICH EITHER RATES
OR FORMS ARE REQUIRED TO BE FILED WITH THE FEDERAL GOVERNMENT
OR THE INSURANCE DEPARTMENT, THIS ACT SHALL APPLY TO ANY
POLICY FOR WHICH A FORM OR RATE IS FIRST FILED ON OR AFTER
180 DAYS AFTER THE DATE OF ENACTMENT OF THIS ACT.
(2) FOR A HEALTH INSURANCE POLICY FOR WHICH NEITHER
RATES NOR FORMS ARE REQUIRED TO BE FILED WITH THE FEDERAL
GOVERNMENT OR THE INSURANCE DEPARTMENT, THIS ACT SHALL APPLY
TO ANY POLICY ISSUED OR RENEWED ON OR AFTER 180 DAYS AFTER
THE DATE OF ENACTMENT OF THIS ACT.
(B) CONTRACTS.--THIS ACT SHALL APPLY TO CONTRACTS BETWEEN
HEALTH CARE PRACTITIONERS AND INSURERS THAT ARE EXECUTED OR
RENEWED ON OR AFTER 180 DAYS AFTER THE DATE OF ENACTMENT OF THIS
ACT.
Section 7 8. Effective date.
This act shall take effect in 180 60 days.
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