SENATE AMENDED
PRIOR PRINTER'S NOS. 2835, 3532
PRINTER'S NO. 4119
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
1698
Session of
2015
INTRODUCED BY HEFFLEY, KINSEY, THOMAS, DRISCOLL, MARSICO,
DiGIROLAMO, TOEPEL, KILLION, HARHAI, TAYLOR, D. PARKER,
TOOHIL, SCHLEGEL CULVER, MASSER, JOZWIAK, HAHN, WARD, KAUFER,
ROZZI, SNYDER, LONGIETTI, HARHART, STAATS, GIBBONS, KLUNK,
O'BRIEN, MURT, BOBACK, GOODMAN, READSHAW, SAYLOR, COHEN,
NESBIT, FABRIZIO, SCHLOSSBERG, MOUL, EVERETT, DONATUCCI,
R. BROWN, PHILLIPS-HILL, FARRY, KORTZ, DAVIS AND SANTARSIERO,
FEBRUARY 9, 2016
AS AMENDED ON THIRD CONSIDERATION, IN SENATE, OCTOBER 25, 2016
AN ACT
Providing for coverage requirements by an insurance carrier or
health insurance plan for abuse-deterrent opioid analgesic
drug products.
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 Abuse-
Deterrent Opioid Analgesic Drug Products Coverage Act.
Section 2. Findings and declarations.
The General Assembly finds and declares as follows:
(1) The abuse of opioids is a serious problem that
affects the health, social and economic welfare of this
Commonwealth.
(2) An estimated 2.1 million people in the United States
suffered from substance use disorders related to prescription
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opioid pain relievers in 2012.
(3) The number of unintentional overdose deaths from
prescription opioid pain relievers has more than quadrupled
in the United States since 1999.
(4) It is imperative for people suffering from pain to
get the relief they need while minimizing the potential for
negative consequences.
(5) The human suffering caused by drug addiction,
including the effect on the loved ones of the individuals
suffering from drug addiction, has now reached epidemic
proportions in this Commonwealth.
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:
"Abuse-deterrent opioid analgesic drug product." A brand or
generic opioid analgesic drug product approved by the United
States Food and Drug Administration AS AN ABUSE-DETERRENT OPIOID
with abuse-deterrence labeling claims indicating its abuse-
deterrent properties are expected to deter or reduce its abuse.
"Cost-sharing." The cost to an individual insured under a
health insurance plan according to any coverage limit,
copayment, coinsurance, deductible or other out-of-pocket
expense requirements imposed by the health insurance plan.
"Health insurance carrier." An entity that offers or issues
a health insurance plan and is subject to any of the following:
(1) 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 THAT ACT.
(2) The act of December 29, 1972 (P.L.1701, No.364),
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known as the Health Maintenance Organization Act.
(3) 40 Pa.C.S. Chs. 61 (relating to hospital plan
corporations) or 63 (relating to professional health services
plan corporations).
"Health insurance plan." A policy, contract, certificate or
agreement offered or issued by a health insurance carrier to
provide for the costs of health care services. The term does not
include the following types of policies:
(1) Accident only.
(2) Limited benefit.
(3) Credit.
(4) Vision.
(5) DENTAL.
(5) (6) Specified disease.
(6) (7) Civilian Health and Medical Program of the
Uniformed Services (CHAMPUS) supplement.
(7) (8) Long-term care or disability income.
(8) (9) Workers' compensation.
(9) (10) Automobile medical payment.
"Opioid analgesic drug product." A drug product that
contains an opioid agonist and is designated by the United
States Food and Drug Administration for the treatment of pain,
notwithstanding whether or not the drug product is in an
immediate release or extended release formulation or contains
other drug substances.
Section 4. Coverage requirements for abuse-deterrent opioid
analgesic drug products.
(a) Requirement.--A IF A health insurance carrier or health
insurance plan shall provide PROVIDES coverage on its formulary,
drug list or other lists of similar construct for at least one
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abuse-deterrent opioid analgesic drug product per opioid
analgesic active ingredient., THEN A HEALTH INSURANCE CARRIER OR
HEALTH INSURANCE PLAN SHALL PROVIDE COVERAGE FOR AT LEAST THREE
ABUSE-DETERRENT OPIOID ANALGESIC DRUG PRODUCTS IN A MANNER THAT
PRESERVES THERAPEUTIC CHOICE FOR PRESCRIBERS AND PATIENTS.
(b) Cost-sharing.--The following apply:
(1) Cost-sharing for brand name abuse-deterrent opioid
analgesic drug products shall not exceed the lowest cost-
sharing level applied to brand name prescription drugs
covered under the health insurance plan.
(2) Cost-sharing for generic abuse-deterrent opioid
analgesic drug products shall not exceed the lowest cost-
sharing level applied to generic prescription drugs covered
under the health insurance plan.
(3) An increase in cost-sharing or other disincentives
for prescribers or dispensers may not be used to achieve
compliance with this section.
Section 5. Utilization management.
(a) Prohibition.--A health insurance carrier or health
insurance plan shall not require an insured or enrollee to first
use a AN OPIOID ANALGESIC drug product that is not an abuse-
deterrent opioid analgesic drug product before providing
coverage for an abuse-deterrent opioid analgesic drug product.
(b) Construction.--Nothing in this section shall be
construed to prevent a health insurance carrier or health
insurance plan from applying utilization review requirements,
including prior authorization, to abuse-deterrent opioid
analgesic drug products if the requirements are applied to all
opioid analgesic drug products with the same type of drug
release, immediate or extended.
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SECTION 6. PRESCRIBING.
(A) GUIDELINES.--THE DEPARTMENT OF HEALTH SHALL ADOPT
MANDATORY, EVIDENCE-BASED GUIDELINES FOR PRESCRIBING ABUSE-
DETERRENT PRESCRIPTION OPIOIDS. THE GUIDELINES SHALL BE
PUBLISHED IN THE PENNSYLVANIA BULLETIN.
(B) EDUCATIONAL MATERIALS.--THE DEPARTMENT OF HEALTH SHALL
DEVELOP EDUCATIONAL MATERIALS TO EXPLAIN THE RISKS ASSOCIATED
WITH ALL OPIOIDS NOTWITHSTANDING THEIR ABUSE-DETERRENT LABELING.
PRESCRIBERS SHALL DISTRIBUTE THESE MATERIALS WITH EVERY OPIOID
PRESCRIPTION REGARDLESS OF WHETHER THE OPIOID BEING PRESCRIBED
HAS ABUSE-DETERRENT PROPERTIES.
Section 6 7. Applicability.
This act shall apply as follows:
(1) For health insurance plans for which rates or forms
are required to be filed with the Insurance Department or the
Federal Government, this act shall apply to a policy for
which a form or rate is filed FIRST PERMITTED TO BE USED on
or after the effective date of this section.
(2) For health insurance plans for which rates or forms
are not required to be filed with the Insurance Department or
the Federal Government, this act shall apply to a policy
issued or renewed on or after 180 days after the effective
date of this section.
Section 7 8. Effective date.
This act shall take effect in 60 days.
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