PRINTER'S NO. 3564
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
2431
Session of
2018
INTRODUCED BY STEPHENS, HAGGERTY, READSHAW, STAATS, HEFFLEY,
DRISCOLL, MURT, MARSICO, LEWIS, MULLERY, PHILLIPS-HILL,
D. COSTA, KAUFER, M. QUINN, CORBIN AND TOPPER, MAY 23, 2018
REFERRED TO COMMITTEE ON HEALTH, MAY 23, 2018
AN ACT
Amending Title 35 (Health and Safety) of the Pennsylvania
Consolidated Statutes, in public safety, providing for opioid
treatment agreements.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. Title 35 of the Pennsylvania Consolidated
Statutes is amended by adding a chapter to read:
CHAPTER 52B
OPIOID TREATMENT AGREEMENTS
Sec.
52B01. Definitions.
52B02. Procedure.
52B03. Regulations.
52B04. Penalties.
§ 52B01. Definitions.
The following words and phrases when used in this chapter
shall have the meanings given to them in this section unless the
context clearly indicates otherwise:
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"Baseline test." The initial assessment through a urine drug
test to:
(1) identify the presence of an illegal substance prior
to prescribing a controlled substance; or
(2) confirm the presence or absence of a prescribed drug
or drug class.
"Controlled substance." A drug, substance or immediate
precursor included in Schedules II through V of section 4 of the
act of April 14, 1972 (P.L.233, No.64), known as The Controlled
Substance, Drug, Device and Cosmetic Act.
"Department." The Department of Health of the Commonwealth.
"Individual." An individual who is at least 18 years of age.
"Medical emergency." A situation that, in the good faith
professional judgment of the prescriber, creates an immediate
threat of serious risk to the life or physical health of a
person.
"Opioid." Any of the following:
(1) A preparation or derivative of opium.
(2) A synthetic narcotic that has opiate-like effects
but is not derived from opium.
(3) A group of naturally occurring peptides that bind at
or otherwise influence opiate receptors, including an opioid
agonist.
"Periodic test." A random urine drug test that screens for a
random selection of drugs.
"Prescriber." An individual who is licensed, registered or
otherwise authorized to distribute, dispense or administer a
controlled substance or prescription drug or device in the
course of professional practice or research in this
Commonwealth. The term shall not include a veterinarian.
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"Presumptive positive drug test." Procedures that are used
to identify suspected possible use or non-use of drugs or a drug
class that may be followed by a definitive test to specifically
identify drugs or metabolites.
"Targeted test." A test ordered at the discretion of a
clinician, based on observation of the clinician and related
circumstances that enhance clinical decision making.
"Treatment agreement." A document signed by a prescriber and
individual that contains a statement to ensure that the
individual understands:
(1) Treatment responsibilities.
(2) The conditions of medication use.
(3) The conditions under which the treatment of the
individual may be terminated.
(4) The responsibilities of the prescriber.
§ 52B02. Procedure.
(a) Prescriber requirements.--Except as specified in
subsection (d), before issuing an individual the first
prescription in a single course of treatment for chronic pain
with a controlled substance containing an opioid, regardless of
whether the dosage is modified during that course of treatment,
a prescriber shall:
(1) Assess whether the individual has taken or is
currently taking a prescription drug for treatment of a
substance use disorder.
(2) Discuss with the individual:
(i) The risks of addiction and overdose associated
with the controlled substance containing an opioid.
(ii) The increased risk of addiction to a controlled
substance, if the individual suffers from a mental
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disorder or substance use disorder.
(iii) The dangers of taking a controlled substance
containing an opioid with benzodiazepines, alcohol or
other central nervous system depressants.
(iv) Other information deemed appropriate by the
prescriber under 21 CFR 201.57(c)(18) (relating to
specific requirements on content and format of labeling
for human prescription drug and biological products
described in § 201.56(b)(1)).
(3) Review and sign a treatment agreement form that
includes:
(i) The goals of the treatment.
(ii) The consent of the individual to a targeted
test in a circumstance where the physician determines
that a targeted test is medically necessary. The
treatment of chronic pain shall be consistent with the
Centers for Disease Control and Prevention guidelines as
they relate to a baseline test and periodic test as
warranted for treatment.
(iii) The prescription drug prescribing policies of
the prescriber, which policies include:
(A) A requirement that the individual take the
medication as prescribed.
(B) A prohibition on sharing the prescribed
medication with other individuals.
(iv) A requirement that the individual inform the
prescriber about any other controlled substances
prescribed or taken by the individual.
(v) Any reason why the opioid therapy may be changed
or discontinued by the prescriber.
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(4) Obtain written consent for the prescription from the
individual.
(5) Record the consent under paragraph (4) on the
treatment agreement form under paragraph (3).
(b) Treatment agreement form requirements.--The treatment
agreement form under subsection (a)(3) shall be maintained by
the prescriber in the medical record of the individual and
include:
(1) The brand name or generic name, quantity and initial
dose of the controlled substance containing an opioid being
prescribed.
(2) A statement indicating that a controlled substance
is a drug or other substance that the United States Drug
Enforcement Administration has identified as having a
potential for abuse.
(3) A statement certifying that the prescriber engaged
in the discussion under subsection (a)(2).
(4) The signature of the individual and the date of
signing.
(c) Drug testing.--
(1) A baseline test, periodic test or targeted test
shall be used to establish a general assessment for an
individual new to treatment for chronic pain and in
monitoring adherence to an existing individual treatment
plan, as well as to detect the use of a nonprescribed drug.
(2) A baseline test shall be required prior to the
issuance of the initial prescription for chronic pain and
shall include confirmatory or quantitative testing of
presumptive positive drug test results.
(3) A prescriber may not issue a prescription opioid
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drug for the treatment of chronic pain without first
obtaining a confirmatory or quantitative testing for
presumptive positive drug test results prior to the initial
issuance of a prescription under paragraph (1).
(4) An individual who is treated for addiction or an
individual who is considered moderate or high risk by the
prescriber shall be tested at least once annually or as
frequently as necessary to ensure therapeutic adherence.
(5) The department shall ensure that presumptive and
definitive urine drug testing methodologies are subject to
reimbursement for prescribers and clinical laboratories under
the Clinical Laboratories Improvement Act of 1967 (Public Law
90-174, 81 Stat. 533). For the purposes of this paragraph,
definitive drug testing includes confirmatory drug testing
and instances where definitive drug testing is the only
method available.
(d) Exception.--Subsection (c) shall not apply if the
treatment of an individual with a controlled substance
containing an opioid is associated with or incident to:
(1) A medical emergency documented in the medical record
of the individual.
(2) The management of pain associated with cancer.
(3) The use in palliative or hospice care.
(4) The professional judgment of the prescriber under
subsection (a)(1) and (2).
(e) Documentation of exemption.--If subsection (d) applies,
the prescriber shall document in the individual's medical record
the factor that the prescriber believes applies under subsection
(d) to the individual.
§ 52B03. Regulations.
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(a) Promulgation.--The department shall promulgate temporary
regulations within 30 days of the effective date of this
subsection. The temporary regulations shall not be subject to:
(1) Sections 201, 202, 203, 204 and 205 of the act of
July 31, 1968 (P.L.769, No.240), referred to as the
Commonwealth Documents Law.
(2) Sections 204(b) and 301(10) of the act of October
15, 1980 (P.L.950, No.164), known as the Commonwealth
Attorneys Act.
(3) The act of June 25, 1982 (P.L.633, No.181), known as
the Regulatory Review Act.
(b) Expiration.--The temporary regulations under subsection
(a) shall expire on the promulgation of final-form regulations,
or two years following the effective date of this section,
whichever is later.
§ 52B04. Penalties.
A violation of this chapter by a prescriber shall be
punishable by a sanction authorized by law by the licensing
board of the prescriber.
Section 2. This act shall take effect immediately.
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