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AN ACT relating to prescription drugs. 1
Be it enacted by the General Assembly of the Commonwealth of Kentucky: 2
Section 1. KRS 205.529 is amended to read as follows: 3
(1) The Department for Medicaid Services or a managed care organization contracted 4
to provide services pursuant to this chapter shall provide a program for 5
synchronization of medications when it is agreed among the member, a provider, 6
and a pharmacist that synchronization of multiple prescriptions for the treatment of 7
a chronic illness is in the best interest of the patient for the management or 8
treatment of a chronic illness provided that the medications: 9
(a) Are covered by the Department for Medicaid Services or a managed care 10
organization contracted to provide services pursuant to this chapter; 11
(b) Are used for treatment and management of chronic conditions that are subject 12
to refills; 13
(c) Are not a Schedule II controlled substance [ or a Schedule III controlled 14
substance containing hydrocodone]; 15
(d) Meet all prior authorization criteria specific to the medications at the time of 16
the synchronization request; 17
(e) Are of a formulation that can be effectively split over required short fill 18
periods to achieve synchronization; and 19
(f) Do not have quantity limits or dose optimization criteria or requirements that 20
would be violated in fulfilling synchronization. 21
(2) When applicable to permit synchron ization, the Department for Medicaid Services 22
or a managed care organization contracted to provide services pursuant to this 23
chapter shall apply a prorated daily cost -sharing rate to any medication dispensed 24
by a network pharmacy pursuant to this section. 25
(3) Any dispensing fee shall not be prorated and shall be based on an individual 26
prescription filled or refilled. 27
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Section 2. KRS 218A.010 is amended to read as follows: 1
As used in this chapter, unless the context otherwise requires: 2
(1) "Administer" means the direct application of a controlled substance, whether by 3
injection, inhalation, ingestion, or any other means, to the body of a patient or 4
research subject by: 5
(a) A practitioner or by his or her authorized agent und er his or her immediate 6
supervision and pursuant to his or her order; or 7
(b) The patient or research subject at the direction and in the presence of the 8
practitioner; 9
(2) "Anabolic steroid" means any drug or hormonal substance chemically and 10
pharmacologically related to testosterone that promotes muscle growth and includes 11
those substances classified as Schedule III controlled substances pursuant to KRS 12
218A.020 but does not include estrogens, progestins, and anticosteroids; 13
(3) "Cabinet" means the Cabinet for Health and Family Services; 14
(4) "Carfentanil" means any substance containing any quantity of carfentanil, or any of 15
its salts, isomers, or salts of isomers; 16
(5) "Certified community based palliative care program" means a palliative care 17
program which has received certification from the Joint Commission; 18
(6) "Child" means any person under the age of majority as specified in KRS 2.015; 19
(7) "Cocaine" means a substance containing any quantity of cocaine, its salts, optical 20
and geometric isomers, and salts of isomers; 21
(8) "Controlled substance" means methamphetamine, or a drug, substance, or 22
immediate precursor in Schedules I through V and includes a controlled substance 23
analogue; 24
(9) (a) "Controlled substance analogue," except as provided in paragraph (b) of this 25
subsection, means a substance: 26
1. The chemical structure of which is substantially similar to the structure 27
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of a controlled substance in Schedule I or II; and 1
2. Which has a stimulant, depressant, or hallucinogenic effect on the 2
central nervous system that is substantially similar to or greater than the 3
stimulant, depressant, or hallucinogenic effect on the central nervous 4
system of a controlled substance in Schedule I or II; or 5
3. With respect to a particular person, which such person represents or 6
intends to have a stimulant, depressant, or hallucinogenic effect on the 7
central nervous system that is substantially similar to or greater than the 8
stimulant, depressant, or hallucinogenic effect on the central nervous 9
system of a controlled substance in Schedule I or II. 10
(b) Such term does not include: 11
1. Any substance for which there is an approved new drug application; 12
2. With respect to a particular person, any substance if an exemption is in 13
effect for investigational use for that person pursuant to fe deral law to 14
the extent conduct with respect to such substance is pursuant to such 15
exemption; or 16
3. Any substance to the extent not intended for human consumption before 17
the exemption described in subparagraph 2. of this paragraph takes 18
effect with respect to that substance; 19
(10) "Counterfeit substance" means a controlled substance which, or the containe r or 20
labeling of which, without authorization, bears the trademark, trade name, or other 21
identifying mark, imprint, number, or device, or any likeness thereof, of a 22
manufacturer, distributor, or dispenser other than the person who in fact 23
manufactured, distributed, or dispensed the substance; 24
(11) "Dispense" means to deliver a controlled substance to an ultimate user or research 25
subject by or pursuant to the lawful order of a practitioner, including the packaging, 26
labeling, or compounding necessary to prepare the substance for that delivery; 27
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(12) "Dispenser" means a person who lawfully dispenses a Schedule II, III, IV, or V 1
controlled substance to or for the use of an ultimate user; 2
(13) "Distribute" means to deliver other than by administering or dispensing a controlled 3
substance; 4
(14) "Dosage unit" means a single pill, capsule, ampule, liquid, or other form of 5
administration available as a single unit; 6
(15) "Drug" means: 7
(a) Substances recognized as drugs in the official United States Pharmacopoeia, 8
official Homeopathic Pharmacopoeia of the United States, or official National 9
Formulary, or any supplement to any of them; 10
(b) Substances intended for use in the diagnosis, care, mitigation, treatment, or 11
prevention of disease in man or animals; 12
(c) Substances (other than food) intended to affect the structure or any function of 13
the body of man or animals; and 14
(d) Substances intended for use as a component of any article specified in this 15
subsection. 16
It does not include devices or their components, parts, or accessories; 17
(16) "Fentanyl" means a substance containing any quantity of fentanyl, or any of its 18
salts, isomers, or salts of isomers; 19
(17) "Fentanyl derivative" means a substance containing any quantity of any chemical 20
compound, except compounds specifically scheduled as controlled substances by 21
statute or by administrative regulation pursuant to this chapter, which is structurally 22
derived from 1-ethyl-4-(N-phenylamido) piperadine: 23
(a) By substitution: 24
1. At the 2-position of the 1-ethyl group with a phenyl, furan, thiophene, or 25
ethyloxotetrazole ring system; and 26
2. Of the terminal amido hydrogen atom with an alkyl, alkoxy, cycloalkyl, 27
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or furanyl group; and 1
(b) Which may be further modified in one (1) or more of the following ways: 2
1. By substitution on the N -phenyl ring to any extent with alkyl, alkoxy, 3
haloalkyl, hydroxyl, or halide substituents; 4
2. By substitution on the piperadine ring to any extent with alkyl, allyl, 5
alkoxy, hydroxy, or halide substituents at the 2 -, 3 -, 5 -, and/or 6 - 6
positions; 7
3. By subst itution on the piperadine ring to any extent with a phenyl, 8
alkoxy, or carboxylate ester substituent at the 4- position; or 9
4. By substitution on the 1 -ethyl group to any extent with alkyl, alkoxy, or 10
hydroxy substituents; 11
(18) "Good-faith prior examinatio n," as used in KRS Chapter 218A and for criminal 12
prosecution only, means an in-person medical examination of the patient conducted 13
by the prescribing practitioner or other health -care professional routinely relied 14
upon in the ordinary course of his or her practice, at which time the patient is 15
physically examined and a medical history of the patient is obtained. "In -person" 16
includes telehealth examinations. This subsection shall not be applicable to hospice 17
providers licensed pursuant to KRS Chapter 216B; 18
(19) "Hazardous chemical substance" includes any chemical substance used or intended 19
for use in the illegal manufacture of a controlled substance as defined in this section 20
or the illegal manufacture of methamphetamine as defined in KRS 218A.1431, 21
which: 22
(a) Poses an explosion hazard; 23
(b) Poses a fire hazard; or 24
(c) Is poisonous or injurious if handled, swallowed, or inhaled; 25
(20) "Heroin" means a substance containing any quantity of heroin, or any of its salts, 26
isomers, or salts of isomers; 27
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(21) "Hydrocodone combination product" means a drug with: 1
(a) Not more than three hundred (300) milligrams of dihydrocodeinone, or any of 2
its s alts, per one hundred (100) milliliters or not more than fifteen (15) 3
milligrams per dosage unit, with a fourfold or greater quantity of an 4
isoquinoline alkaloid of opium; or 5
(b) Not more than three hundred (300) milligrams of dihydrocodeinone, or any of 6
its salts, per one hundred (100) milliliters or not more than fifteen (15) 7
milligrams per dosage unit, with one (1) or more active, nonnarcotic 8
ingredients in recognized therapeutic amounts; 9
(22) "Immediate precursor" means a substance which is the principa l compound 10
commonly used or produced primarily for use, and which is an immediate chemical 11
intermediary used or likely to be used in the manufacture of a controlled substance 12
or methamphetamine, the control of which is necessary to prevent, curtail, or lim it 13
manufacture; 14
(23) "Industrial hemp" has the same meaning as in KRS 260.850; 15
(24) "Industrial hemp products" has the same meaning as in KRS 260.850; 16
(25) "Intent to manufacture" means any evidence which demonstrates a person's 17
conscious objective to manu facture a controlled substance or methamphetamine. 18
Such evidence includes but is not limited to statements and a chemical substance's 19
usage, quantity, manner of storage, or proximity to other chemical substances or 20
equipment used to manufacture a controlled substance or methamphetamine; 21
(26) "Isomer" means the optical isomer, except the Cabinet for Health and Family 22
Services may include the optical, positional, or geometric isomer to classify any 23
substance pursuant to KRS 218A.020; 24
(27) "Manufacture," excep t as provided in KRS 218A.1431, means the production, 25
preparation, propagation, compounding, conversion, or processing of a controlled 26
substance, either directly or indirectly by extraction from substances of natural 27
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origin or independently by means of che mical synthesis, or by a combination of 1
extraction and chemical synthesis, and includes any packaging or repackaging of 2
the substance or labeling or relabeling of its container except that this term does not 3
include activities: 4
(a) By a practitioner as an incident to his or her administering or dispensing of a 5
controlled substance in the course of his or her professional practice; 6
(b) By a practitioner, or by his or her authorized agent under his or her 7
supervision, for the purpose of, or as an incident to, research, teaching, or 8
chemical analysis and not for sale; or 9
(c) By a pharmacist as an incident to his or her dispensing of a controlled 10
substance in the course of his or her professional practice; 11
(28) "Marijuana" means all parts of the plant Cannabis s p., whether growing or not; the 12
seeds thereof; the resin extracted from any part of the plant; and every compound, 13
manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin 14
or any compound, mixture, or preparation which contai ns any quantity of these 15
substances. The term "marijuana" does not include: 16
(a) Industrial hemp that is in the possession, custody, or control of a person who 17
holds a license issued by the Department of Agriculture permitting that person 18
to cultivate, handle, or process industrial hemp; 19
(b) Industrial hemp products that do not include any living plants, viable seeds, 20
leaf materials, or floral materials; 21
(c) The substance cannabidiol, when transferred, dispensed, or administered 22
pursuant to the written order of a physician practicing at a hospital or 23
associated clinic affiliated with a Kentucky public university having a college 24
or school of medicine; 25
(d) For persons participating in a clinical trial or in an expanded access program, 26
a drug or substance appro ved for the use of those participants by the United 27
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States Food and Drug Administration; 1
(e) A cannabidiol product derived from industrial hemp, as defined in KRS 2
260.850; 3
(f) For the purpose of conducting scientific research, a cannabinoid product 4
derived from industrial hemp, as defined in KRS 260.850; 5
(g) A cannabinoid product approved as a prescription medication by the United 6
States Food and Drug Administration; or 7
(h) Medicinal cannabis as defined in KRS 218B.010; 8
(29) "Medical history," as used in KRS Chapter 218A and for criminal prosecution only, 9
means an accounting of a patient's medical background, including but not limited to 10
prior medical conditions, prescriptions, and family background; 11
(30) "Medical order," as used in KRS Chapter 218A and for criminal prosecution only, 12
means a lawful order of a specifically identified practitioner for a specifically 13
identified patient for the patient's health -care needs. "Medical order" may or may 14
not include a prescription drug order; 15
(31) "Medical record," as used in KRS Chapter 218A and for criminal prosecution only, 16
means a record, other than for financial or billing purposes, relating to a patient, 17
kept by a practitioner as a result of the practitioner-patient relationship; 18
(32) "Methamphetamine" means any substance that contains any quantity of 19
methamphetamine, or any of its salts, isomers, or salts of isomers; 20
(33) "Narcotic drug" means any of the following, whether produced directly or indirectly 21
by extraction from substances of vegetable origin, or indep endently by means of 22
chemical synthesis, or by a combination of extraction and chemical synthesis: 23
(a) Opium and opiate, and any salt, compound, derivative, or preparation of 24
opium or opiate; 25
(b) Any salt, compound, isomer, derivative, or preparation thereof which is 26
chemically equivalent or identical with any of the substances referred to in 27
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paragraph (a) of this subsection, but not including the isoquinoline alkaloids 1
of opium; 2
(c) Opium poppy and poppy straw; 3
(d) Coca leaves, except coca leaves and extracts of coca leaves from which 4
cocaine, ecgonine, and derivatives of ecgonine or their salts have been 5
removed; 6
(e) Cocaine, its salts, optical and geometric isomers, and salts of isomers; 7
(f) Ecgonine, its derivatives, their salts, isomers, and salts of isomers; and 8
(g) Any compound, mixture, or preparation which contains any quantity of any of 9
the substances referred to in paragraphs (a) to (f) of this subsection; 10
(34) "Opiate" means any substance having an addiction-forming or addiction-sustaining 11
liability similar to morphine or being capable of conversion into a drug having 12
addiction-forming or addiction -sustaining liability. It does not include, unless 13
specifically designated as controlled unde r KRS 218A.020, the dextrorotatory 14
isomer of 3 -methoxy-n-methylmorphinan and its salts (dextromethorphan). It does 15
include its racemic and levorotatory forms; 16
(35) "Opium poppy" means the plant of the species papaver somniferum L., except its 17
seeds; 18
(36) "Person" means individual, corporation, government or governmental subdivision 19
or agency, business trust, estate, trust, partnership or association, or any other legal 20
entity; 21
(37) "Physical injury" has the same meaning it has in KRS 500.080; 22
(38) "Poppy straw" means all parts, except the seeds, of the opium poppy, after mowing; 23
(39) "Pharmacist" means a natural person licensed by this state to engage in the practice 24
of the profession of pharmacy; 25
(40) "Practitioner" means a physician, dentist, podiatrist, v eterinarian, scientific 26
investigator, optometrist as authorized in KRS 320.240, advanced practice 27
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registered nurse as authorized under KRS 314.011, physician assistant as authorized 1
under KRS 311.858, or other person licensed, registered, or otherwise perm itted by 2
state or federal law to acquire, distribute, dispense, conduct research with respect to, 3
or to administer a controlled substance in the course of professional practice or 4
research in this state. "Practitioner" also includes a physician, dentist, p odiatrist, 5
veterinarian, optometrist, physician assistant, or advanced practice registered nurse 6
[authorized under KRS 314.011 ] who is a resident of and actively practicing in a 7
state other than Kentucky and who is licensed and has prescriptive authority f or 8
controlled substances under the professional licensing laws of another state, unless 9
the person's Kentucky license has been revoked, suspended, restricted, or probated, 10
in which case the terms of the Kentucky license shall prevail; 11
(41) "Practitioner-patient relationship," as used in KRS Chapter 218A and for criminal 12
prosecution only, means a medical relationship that exists between a patient and a 13
practitioner or the practitioner's designee, after the practitioner or his or her 14
designee has conducted at least one (1) good-faith prior examination; 15
(42) "Prescription" means a written, electronic, or oral order for a drug or medicine, or 16
combination or mixture of drugs or medicines, or proprietary preparation, signed or 17
given or authorized by a medical, den tal, chiropody, veterinarian, optometric 18
practitioner, or advanced practice registered nurse, and intended for use in the 19
diagnosis, cure, mitigation, treatment, or prevention of disease in man or other 20
animals; 21
(43) "Prescription blank," with reference to a controlled substance, means a document 22
that meets the requirements of KRS 218A.204 and 217.216; 23
(44) "Presumptive probation" means a sentence of probation not to exceed the maximum 24
term specified for the offense, subject to conditions otherwise authoriz ed by law, 25
that is presumed to be the appropriate sentence for certain offenses designated in 26
this chapter, notwithstanding contrary provisions of KRS Chapter 533. That 27
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presumption shall only be overcome by a finding on the record by the sentencing 1
court of substantial and compelling reasons why the defendant cannot be safely and 2
effectively supervised in the community, is not amenable to community -based 3
treatment, or poses a significant risk to public safety; 4
(45) "Production" includes the manufacture, planting, cultivation, growing, or harvesting 5
of a controlled substance; 6
(46) "Recovery program" means an evidence -based, nonclinical service that assists 7
individuals and families working toward sustained recovery from substance use and 8
other criminal risk fa ctors. This can be done through an array of support programs 9
and services that are delivered through residential and nonresidential means; 10
(47) "Salvia" means Salvia divinorum or Salvinorin A and includes all parts of the plant 11
presently classified botanic ally as Salvia divinorum, whether growing or not, the 12
seeds thereof, any extract from any part of that plant, and every compound, 13
manufacture, derivative, mixture, or preparation of that plant, its seeds, or its 14
extracts, including salts, isomers, and salt s of isomers whenever the existence of 15
such salts, isomers, and salts of isomers is possible within the specific chemical 16
designation of that plant, its seeds, or extracts. The term shall not include any other 17
species in the genus salvia; 18
(48) "Second or s ubsequent offense" means that for the purposes of this chapter an 19
offense is considered as a second or subsequent offense, if, prior to his or her 20
conviction of the offense, the offender has at any time been convicted under this 21
chapter, or under any statu te of the United States, or of any state relating to 22
substances classified as controlled substances or counterfeit substances, except that 23
a prior conviction for a nontrafficking offense shall be treated as a prior offense 24
only when the subsequent offense is a nontrafficking offense. For the purposes of 25
this section, a conviction voided under KRS 218A.275 or 218A.276 shall not 26
constitute a conviction under this chapter; 27
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(49) "Sell" means to dispose of a controlled substance to another person for 1
consideration or in furtherance of commercial distribution; 2
(50) "Serious physical injury" has the same meaning it has in KRS 500.080; 3
(51) "Synthetic cannabinoids or piperazines" means any chemical compound which is 4
not approved by the United States Food and Drug Ad ministration or, if approved, 5
which is not dispensed or possessed in accordance with state and federal law, that 6
contains Benzylpiperazine (BZP); Trifluoromethylphenylpiperazine (TFMPP); 1,1 -7
Dimethylheptyl-11-hydroxytetrahydrocannabinol (HU -210); 1 -Butyl-3-(1-8
naphthoyl)indole; 1 -Pentyl-3-(1-naphthoyl)indole; dexanabinol (HU -211); or any 9
compound in the following structural classes: 10
(a) Naphthoylindoles: Any compound containing a 3 -(1-naphthoyl)indole 11
structure with substitution at the nitrogen atom of the i ndole ring by an alkyl, 12
haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl, 1 -(N-methyl-2-13
piperidinyl)methyl, or 2 -(4-morpholinyl)ethyl group, whether or not further 14
substituted in the indole ring to any extent and whether or not substituted in 15
the naphthyl ring to any extent. Examples of this structural class include but 16
are not limited to JWH-015, JWH-018, JWH-019, JWH-073, JWH-081, JWH-17
122, JWH-200, and AM-2201; 18
(b) Phenylacetylindoles: Any compound containing a 3 -phenylacetylindole 19
structure with substitution at the nitrogen atom of the indole ring by an alkyl, 20
haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl, 1 -(N-methyl-2-21
piperidinyl)methyl, or 2 -(4-morpholinyl)ethyl group whether or not further 22
substituted in the indole ring to any extent and whether or not substituted in 23
the phenyl ring to any extent. Examples of this structural class include but are 24
not limited to JWH-167, JWH-250, JWH-251, and RCS-8; 25
(c) Benzoylindoles: Any compound containing a 3-(benzoyl)indole structure with 26
substitution at the nitrogen atom of the indole ring by an alkyl, haloalkyl, 27
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alkenyl, cycloalkylmethyl, cycloalkylethyl, 1 -(N-methyl-2-1
piperidinyl)methyl, or 2 -(4-morpholinyl)ethyl group whether or not further 2
substituted in the indole ring to any extent and whether or not substituted in 3
the phenyl ring to any extent. Examples of this structural class include but are 4
not limited to AM -630, AM-2233, AM-694, Pravadoline (WIN 48,098), and 5
RCS-4; 6
(d) Cyclohexylphenols: Any compound containing a 2 -(3-7
hydroxycyclohexyl)phenol structure with substitution at the 5 -position of the 8
phenolic ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl, 9
cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl, or 2 -(4-morpholinyl)ethyl 10
group whether or not substituted in the cyclohexyl ring to a ny extent. 11
Examples of this structural class include but are not limited to CP 47,497 and 12
its C8 homologue (cannabicyclohexanol); 13
(e) Naphthylmethylindoles: Any compound containing a 1H -indol-3-yl-(1-14
naphthyl)methane structure with substitution at the nitrogen atom of the 15
indole ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl, 16
1-(N-methyl-2-piperidinyl)methyl, or 2-(4-morpholinyl)ethyl group whether 17
or not further substituted in the indole ring to any extent and whether or not 18
substituted in the naphthyl ring to any extent. Examples of this structural class 19
include but are not limited to JWH-175, JWH-184, and JWH-185; 20
(f) Naphthoylpyrroles: Any compound containing a 3 -(1-naphthoyl)pyrrole 21
structure with substitution at the nitrogen atom of the pyrrole ring by an alkyl, 22
haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl, 1 -(N-methyl-2-23
piperidinyl)methyl, or 2 -(4-morpholinyl)ethyl group whether or not further 24
substituted in the pyrrole ring to any extent and whether or not substituted in 25
the naphthyl ring to any extent. Examples of this structural class include but 26
are not limited to JWH-030, JWH-145, JWH-146, JWH-307, and JWH-368; 27
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(g) Naphthylmethylindenes: Any compound containing a 1 -(1-1
naphthylmethyl)indene structure with substitution at the 3 -position of the 2
indene ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl, 3
1-(N-methyl-2-piperidinyl)methyl, or 2 -(4-morpholinyl)ethyl group whether 4
or not further substituted in the indene ring to any extent and whether or not 5
substituted in the naphthyl ring to any extent. Examples of this structural class 6
include but are not limited to JWH-176; 7
(h) Tetramethylcyclopropanoylindoles: Any compound containing a 3 -(1-8
tetramethylcyclopropoyl)indole structure with substitution at the nitrogen 9
atom of the indole ring by an alkyl, haloalkyl, cycloalkylmethyl, 10
cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl, or 2-(4-morpholinyl)ethyl 11
group, whether or not further substituted in the indole ring to any extent and 12
whether or not further substituted in the tetramethylcyclopropyl ring to any 13
extent. Examples of this structural class include but are not limited to UR -144 14
and XLR-11; 15
(i) Adamantoylindoles: Any compound containing a 3 -(1-adamantoyl)indole 16
structure with substitution at the nitrogen atom of the indole ring by an alkyl, 17
haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl, 1 -(N-methyl-2-18
piperidinyl)methyl, or 2 -(4-morpholinyl)ethyl group, whether or not further 19
substituted in the indole ring to any extent and whether or not substituted in 20
the adamantyl ring system to any extent. Examples of this structural class 21
include but are not limited to AB-001 and AM-1248; or 22
(j) Any other synthetic cannabinoid or piperazine which is not approved by the 23
United States Food and Drug Administration or, if approved, which is not 24
dispensed or possessed in accordance with state and federal law; 25
(52) "Synthetic cathinones" m eans any chemical compound which is not approved by 26
the United States Food and Drug Administration or, if approved, which is not 27
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dispensed or possessed in accordance with state and federal law (not including 1
bupropion or compounds listed under a different schedule) structurally derived from 2
2-aminopropan-1-one by substitution at the 1 -position with either phenyl, naphthyl, 3
or thiophene ring systems, whether or not the compound is further modified in one 4
(1) or more of the following ways: 5
(a) By substitution in the ring system to any extent with alkyl, alkylenedioxy, 6
alkoxy, haloalkyl, hydroxyl, or halide substituents, whether or not further 7
substituted in the ring system by one (1) or more other univalent substituents. 8
Examples of this class include but are not limited to 3,4 -9
Methylenedioxycathinone (bk-MDA); 10
(b) By substitution at the 3 -position with an acyclic alkyl substituent. Examples 11
of this class include but are not limited to 2 -methylamino-1-phenylbutan-1-12
one (buphedrone); 13
(c) By substitution at the 2 -amino nitrogen atom with alkyl, dialkyl, benzyl, or 14
methoxybenzyl groups, or by inclusion of the 2 -amino nitrogen atom in a 15
cyclic structure. Examples of this class include but are not limited to 16
Dimethylcathinone, Ethcathinone, and -Pyrrolidinopropiophenone (-PPP); 17
or 18
(d) Any other synthetic cathinone which is not approved by the United States 19
Food and Drug Administration or, if approved, is not dispensed or possessed 20
in accordance with state or federal law; 21
(53) "Synthetic drugs" means any synthetic cannabinoids or piperazines or any synthetic 22
cathinones; 23
(54) "Telehealth" has the same meaning it has in KRS 211.332; 24
(55) "Tetrahydrocannabinols" means synthetic equivalents of the substances contai ned 25
in the plant, or in the resinous extractives of the plant Cannabis, sp. or synthetic 26
substances, derivatives, and their isomers with similar chemical structure and 27
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pharmacological activity such as the following: 1
(a) Delta 1 cis or trans tetrahydrocannabinol, and their optical isomers; 2
(b) Delta 6 cis or trans tetrahydrocannabinol, and their optical isomers; and 3
(c) Delta 3, 4 cis or trans tetrahydrocannabinol, and its optical isomers; 4
(56) "Traffic," except as provided in KRS 218A.1431, means to manufac ture, distribute, 5
dispense, sell, transfer, or possess with intent to manufacture, distribute, dispense, 6
or sell a controlled substance; 7
(57) "Transfer" means to dispose of a controlled substance to another person without 8
consideration and not in furtherance of commercial distribution; and 9
(58) "Ultimate user" means a person who lawfully possesses a controlled substance for 10
his or her own use or for the use of a member of his or her household or for 11
administering to an animal owned by him or her or by a mem ber of his or her 12
household. 13
Section 3. KRS 218A.172 is amended to read as follows: 14
(1) Administrative regulations promulgated under KRS 218A.205(3) shall require that, 15
prior to the initial prescribing or dispensing of any Schedule II controlled substance 16
[or a Schedule III controlled substance containing hydrocodone ]to a human patient, 17
a practitioner shall: 18
(a) Obtain a medical history and conduct a physical or mental health examination 19
of the patient, as appropriate to the patient's medical complaint, and document 20
the information in the patient's medical record; 21
(b) Query the electronic monitoring system established in KRS 218A.202 for all 22
available data on the patient for the twelve (12) month period immediately 23
preceding the patient encounter and appropriately utilize that data in the 24
evaluation and treatment of the patient; 25
(c) Make a written plan stating the objectives of the treatment and further 26
diagnostic examinations required; 27
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(d) Discuss the risks and benefits of the use of controlled substances with the 1
patient, the patient's parent if the patient is an unemancipated minor child, or 2
the patient's legal guardian or health care surrogate, including the risk of 3
tolerance and drug dependence; and 4
(e) Obtain written consent for the treatment. 5
(2) (a) Administrative regulations promulgated under KRS 218A.205(3) shall require 6
that a practitioner prescribing or dispensing additional amounts of Schedule II 7
controlled substances [or Schedule III controlled substances cont aining 8
hydrocodone ]for the same medical complaint and related symptoms shall: 9
1. Review, at reasonable intervals based on the patient's individual 10
circumstances and course of treatment, the plan of care; 11
2. Provide to the patient any new information about the treatment; and 12
3. Modify or terminate the treatment as appropriate. 13
(b) If the course of treatment extends beyond three (3) months, the administrative 14
regulations shall also require that the practitioner: 15
1. Query the electronic monitoring system established in KRS 218A.202 16
no less than once every three (3) months for all available data on the 17
patient for the twelve (12) month period immediately preceding the 18
query; and 19
2. Review that data before issuing any new prescription or refills for the 20
patient for any Schedule II controlled substance [ or a Schedule III 21
controlled substance containing hydrocodone]. 22
(3) Administrative regulations promulgated under KRS 218A.205(3) shall require 23
that[,] for each patient for whom a practitioner prescribes any Schedule II 24
controlled substance [or a Schedule III controlled substance containing 25
hydrocodone, ]the practitioner shall keep accurate, readily accessible, and complete 26
medical records which include, as appropriate: 27
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(a) Medical history and physical or mental health examination; 1
(b) Diagnostic, therapeutic, and laboratory results; 2
(c) Evaluations and consultations; 3
(d) Treatment objectives; 4
(e) Discussion of risk, benefits, and limitations of treatments; 5
(f) Treatments; 6
(g) Medications, including date, type, dosage, and quantity prescribed or 7
dispensed; 8
(h) Instructions and agreements; and 9
(i) Periodic reviews of the patient's file. 10
(4) Administrative regulations promulgated under KRS 218A.205(3) may exempt, in 11
whole or in part, compliance with the mandatory diagnostic, treatment, review, and 12
other protocols and standards established in this section for: 13
(a) A licensee prescribing or administering a controlled substance immediately 14
prior to, during, or within the fourteen (14) days following an operative or 15
invasive procedure or a delivery if the prescribing or administering is 16
medically related t o the operative or invasive procedure or the delivery and 17
the medication usage does not extend beyond the fourteen (14) days; 18
(b) A licensee prescribing or administering a controlled substance necessary to 19
treat a patient in an emergency situation; 20
(c) A l icensed pharmacist or other person licensed by the Kentucky Board of 21
Pharmacy to dispense drugs or a licensed pharmacy; 22
(d) A licensee prescribing or dispensing a controlled substance: 23
1. For administration in a hospital or long -term-care facility if the h ospital 24
or long-term-care facility with an institutional account, or a practitioner 25
in those hospitals or facilities where no institutional account exists, 26
queries the electronic monitoring system established in KRS 218A.202 27
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for all available data on the patient or resident for the twelve (12) month 1
period immediately preceding the query within twelve (12) hours of the 2
patient's or resident's admission and places a copy of the query in the 3
patient's or resident's medical records during the duration of the p atient's 4
stay at the facility; 5
2. As part of the patient's hospice or end-of-life treatment; 6
3. For the treatment of pain associated with cancer or with the treatment of 7
cancer; 8
4. In a single dose to relieve the anxiety, pain, or discomfort experienced 9
by a patient submitting to a diagnostic test or procedure; 10
5. Within seven (7) days of an initial prescribing or dispensing under 11
subsection (1) of this section if the prescribing or dispensing: 12
a. Is done as a substitute for the initial prescribing or dispensing; 13
b. Cancels any refills for the initial prescription; and 14
c. Requires the patient to dispose of any remaining unconsumed 15
medication; 16
6. Within ninety (90) days of an initial prescribing or d ispensing under 17
subsection (1) of this section if the prescribing or dispensing is done by 18
another practitioner in the same practice or in an existing coverage 19
arrangement, if done for the same patient for the same medical 20
condition; or 21
7. To a research su bject enrolled in a research protocol approved by an 22
institutional review board that has an active federalwide assurance 23
number from the United States Department of Health and Human 24
Services, Office for Human Research Protections, where the research 25
involves single, double, or triple blind drug administration or is 26
additionally covered by a certificate of confidentiality from the National 27
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Institutes of Health; 1
(e) The prescribing of a Schedule III, IV, or V controlled substance by a licensed 2
optometrist to a patient in accordance with the provisions of KRS 320.240; or 3
(f) The prescribing of a three (3) day supply of a Schedule III controlled 4
substance following the performance of oral surgery by a dentist licensed 5
pursuant to KRS Chapter 313. 6
(5) (a) A state licensing board promulgating administrative regulations under KRS 7
218A.205(3) may promulgate an administrative regulation in accordance 8
with KRS Chapter 13A authorizing exemptions supplemental or in addition to 9
those specified in subsection (4) of this se ction. Prior to exercising this 10
authority, the board shall: 11
1. Notify the Kentucky Office of Drug Control Policy that it is considering 12
a proposal to promulgate an administrative regulation authorizing 13
exemptions supplemental or in addition to those specif ied in subsection 14
(4) of this section and invite the office to participate in the board 15
meeting at which the proposal will be considered; 16
2. Make a factual finding based on expert testimony as well as evidence or 17
research submitted to the board that the ex emption demonstrates a low 18
risk of diversion or abuse and is supported by the dictates of good 19
medical practice; and 20
3. Submit a report to the Governor and the Legislative Research 21
Commission of its actions, including a detailed explanation of the 22
factual and policy basis underlying the board's action. A copy of this 23
report shall be provided to the regulations compiler. 24
(b) Within one (1) working day of promulgating an administrative regulation 25
authorizing an exemption under this section, the promulgating b oard shall 26
email[e-mail] to the Kentucky Office of Drug Control Policy: 27
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1. A copy of the administrative regulation as filed, and all attachments 1
required by KRS 13A.230(1); and 2
2. A request from the board that the office review the administrative 3
regulation in the same manner as would the Commission on Small 4
Business Innovation and Advocacy under KRS 11.202(1)(e), and submit 5
its report or comments in accordance with the deadline established in 6
KRS 13A.270(1)(c). A copy of the report or comments shall be fil ed 7
with the regulations compiler. 8
Section 4. KRS 218A.182 is amended to read as follows: 9
(1) Notwithstanding KRS 218A.180 or any other state law to the contrary, beginning 10
January 1, 2021, no practitioner shall issue any prescription for a controlled 11
substance unless the prescription is made by electronic prescription from the 12
practitioner issuing the prescription to a pharmacy, except for prescriptions issued: 13
(a) By veterinarians; 14
(b) In circumstances where electronic p rescribing is not available due to 15
temporary technological or electrical failure; 16
(c) By a practitioner to be dispensed by a pharmacy located outside the state; 17
(d) When the prescriber and dispenser are the same entity; 18
(e) That include elements that are n ot supported by the most recently 19
implemented version of the National Council for Prescription Drug Programs 20
Prescriber/Pharmacist Interface SCRIPT Standard; 21
(f) By a practitioner for a drug that contains certain elements that cannot be 22
incorporated as req uired by the United States Food and Drug Administration 23
with electronic prescribing, including extemporaneous compounding; 24
(g) By a practitioner allowing for the dispensing of a nonpatient specific 25
prescription under a standing order, approved protocol for drug therapy, or 26
collaborative drug management or comprehensive medication management, in 27
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response to a public health emergency; 1
(h) By a practitioner prescribing a drug under a research protocol; 2
(i) By practitioners who have received a waiver or a renew al thereof, from the 3
requirement to use electronic prescribing due to economic hardship, 4
technological limitations that are not reasonably within the control of the 5
practitioner, or other exceptional circumstance demonstrated by the 6
practitioner. The initi al waiver and each subsequent waiver renewal shall not 7
exceed one (1) year per waiver or waiver renewal; 8
(j) By a practitioner under circumstances where, notwithstanding the 9
practitioner's present ability to make an electronic prescription as required by 10
this subsection, the practitioner reasonably determines that it would be 11
impractical for the patient to obtain substances prescribed by electronic 12
prescription in a timely manner, and delay would adversely impact the 13
patient's medical condition; 14
(k) By a practitioner for an individual who receives hospice care;[ or] 15
(l) By a practitioner for an individual who is a resident of a nursing facility; or 16
(m) By a practitioner who is issuing a prescription as part of providing 17
charitable health care services pursuant to the Kentucky Charitable Health 18
Care Services Act, KRS 216.940 to 216.945. 19
(2) A pharmacist who receives a written, oral, or faxed prescription for a controlled 20
substance shall not be required to verify that the prescription properly falls under 21
one (1) of the exceptions from the requirement to electronically prescribe. 22
Pharmacists m ay continue to dispense medications from otherwise valid written, 23
oral, or fax prescriptions that are consistent with current laws and administrative 24
regulations. 25
(3) The cabinet shall promulgate administrative regulations to implement this section 26
including enforcement mechanisms, waivers of requirements, and appropriate 27
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penalties for violations. 1
Section 5. KRS 218A.202 is amended to read as follows: 2
(1) As used in this section: 3
(a) "Cabinet" means the Cabinet for Health and Family Services; 4
(b) "Cannabis business" has the same meaning as in KRS 218B.010; 5
(c) "Controlled substance" means any Schedule II, III, IV, or V controlled 6
substance and does not include medicinal cannabis; 7
(d) "Dispensary" has the same meaning as in KRS 218B.010; 8
(e) "Dispensary agent" has the same meaning as in KRS 218B.010; 9
(f) "Disqualifying felony offense" has the same meaning as in KRS 218B.010; 10
(g) "Medicinal cannabis" has the same meaning as in KRS 218B.010; 11
(h) "Medicinal cannabis practitioner" has the same meaning as in KRS 218B.010; 12
(i) "Registry identification card" has the same meaning as in KRS 218B.010; 13
(j) "State licensing board" has the same meaning as in KRS 218B.010; 14
(k) "Use of medicinal cannabis" has the same meaning as in KRS 218B.010; and 15
(l) "Written certification" has the same meaning as in KRS 218B.010. 16
(2) The cabinet shall establish and maintain an electronic system for monitoring 17
Schedules II, III, IV, and V controlled substances and medicinal cannabis. The 18
cabinet may contr act for the design, upgrade, or operation of this system if the 19
contract preserves all of the rights, privileges, and protections guaranteed to 20
Kentucky citizens under this chapter and the contract requires that all other aspects 21
of the system be operated in conformity with the requirements of this or any other 22
applicable state or federal law. 23
(3) For the purpose of monitoring the prescribing and dispensing of Schedule II, III, IV, 24
or V controlled substances: 25
(a) A practitioner or a pharmacist authorized to prescribe or dispense controlled 26
substances to humans shall register with the cabinet to use the system 27
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provided for in this section and shall maintain an active account with the 1
electronic monitoring system [such registration] continuously during the 2
practitioner's or pharmacist's term of licensure and shall not have to pay a fee 3
or tax specifically dedicated to the operation of the system; 4
(b) Every practitioner or pharmacy which dispenses a controlled substance to a 5
person in Kentucky, or to a person at an address in Kentucky, shall report to 6
the cabinet the data required by this section, which includes the reporting of 7
any Schedule II controlled substance dispensed at a facility licensed by the 8
cabinet and a Schedule II through Schedule V controlled subs tance regardless 9
of dosage when dispensed by the emergency department of a hospital to an 10
emergency department patient. Reporting shall not be required for: 11
1. A drug administered directly to a patient in a hospital, a resident of a 12
health care facility li censed under KRS Chapter 216B, a resident of a 13
child-caring facility as defined by KRS 199.011, or an individual in a 14
jail, correctional facility, or juvenile detention facility; 15
2. A Schedule III through Schedule V controlled substance dispensed by a 16
facility licensed by the cabinet provided that the quantity dispensed is 17
limited to an amount adequate to treat the patient for a maximum of 18
forty-eight (48) hours and is not dispensed by the emergency department 19
of a hospital; or 20
3. A drug administered or dispensed to a research subject enrolled in a 21
research protocol approved by an institutional review board that has an 22
active federalwide assurance number from the United States Department 23
of Health and Human Services, Office for Huma n Research Protections, 24
where the research involves single, double, or triple blind drug 25
administration or is additionally covered by a certificate of 26
confidentiality from the National Institutes of Health; 27
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(c) In addition to the data required by paragraph (d) of this subsection, a 1
Kentucky-licensed acute care hospital or critical access hospital shall report to 2
the cabinet all positive toxicology screens that were performed by the 3
hospital's emergency department to evaluate the patient's suspected drug 4
overdose; 5
(d) Data for each controlled substance that is reported shall include but not be 6
limited to the following: 7
1. Patient identifier; 8
2. National drug code of the drug dispensed; 9
3. Date of dispensing; 10
4. Quantity dispensed; 11
5. Prescriber; and 12
6. Dispenser; 13
(e) The data shall be provided in the electronic format specified by the cabinet 14
unless a waiver has been granted by the cabinet to an individual dispenser. 15
The cabinet shall establish acceptable error tolerance rates for data. 16
Dispensers shall ensure that reports fall within these tolerances. Incomplete or 17
inaccurate data shall be corrected upon notification by the cabinet if the 18
dispenser exceeds these error tolerance rates; 19
(f) The cabinet shall only disclose data to persons and entities authorized to 20
receive that data under this subsection. Disclosure to any other person or 21
entity, including disclosure in the context of a civil action where the 22
disclosure is sought either for the purpose of discovery or for evidence, is 23
prohibited unless specificall y authorized by this section. The cabinet shall be 24
authorized to provide data to: 25
1. A designated representative of a board responsible for the licensure, 26
regulation, or discipline of practitioners, pharmacists, or other person 27
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who is authorized to prescri be, administer, or dispense controlled 1
substances and who is involved in a bona fide specific investigation 2
involving a designated person; 3
2. Employees of the Office of the Inspector General of the cabinet who 4
have successfully completed training for the e lectronic system and who 5
have been approved to use the system, federal prosecutors, Kentucky 6
Commonwealth's attorneys and assistant Commonwealth's attorneys, 7
county attorneys and assistant county attorneys, a peace officer certified 8
pursuant to KRS 15.380 to 15.404, a certified or full -time peace officer 9
of another state, or a federal agent whose duty is to enforce the laws of 10
this Commonwealth, of another state, or of the United States relating to 11
drugs and who is engaged in a bona fide specific investigat ion involving 12
a designated person; 13
3. A state-operated Medicaid program in conformity with paragraph (g) of 14
this subsection; 15
4. A properly convened grand jury pursuant to a subpoena properly issued 16
for the records; 17
5. A practitioner or pharmacist, or emplo yee of the practitioner's or 18
pharmacist's practice acting under the specific direction of the 19
practitioner or pharmacist, who certifies that the requested information 20
is for the purpose of: 21
a. Providing medical or pharmaceutical treatment to a bona fide 22
current or prospective patient; 23
b. Reviewing data on controlled substances that have been reported 24
for the birth mother of an infant who is currently being treated by 25
the practitioner for neonatal abstinence syndrome, or has 26
symptoms that suggest prenatal drug exposure; or 27
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c. Reviewing and assessing the individual prescribing or dispensing 1
patterns of the practitioner or pharmacist or to determine the 2
accuracy and completeness of information contained in the 3
monitoring system; 4
6. The chief medical officer of a hospital or long -term-care facility, an 5
employee of the hospital or long -term-care facility as designated by the 6
chief medical officer and who is working under his or her specific 7
direction, or a physician designee if the hospital or facility has no chie f 8
medical officer, if the officer, employee, or designee certifies that the 9
requested information is for the purpose of providing medical or 10
pharmaceutical treatment to a bona fide current or prospective patient or 11
resident in the hospital or facility; 12
7. In addition to the purposes authorized under subparagraph 1. of this 13
paragraph, the Kentucky Board of Medical Licensure, for any physician 14
who is: 15
a. Associated in a partnership or other business entity with a 16
physician who is already under investigation b y the Board of 17
Medical Licensure for improper prescribing or dispensing 18
practices; 19
b. In a designated geographic area for which a trend report indicates 20
a substantial likelihood that inappropriate prescribing or 21
dispensing may be occurring; or 22
c. In a desi gnated geographic area for which a report on another 23
physician in that area indicates a substantial likelihood that 24
inappropriate prescribing or dispensing may be occurring in that 25
area; 26
8. In addition to the purposes authorized under subparagraph 1. of th is 27
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paragraph, the Kentucky Board of Nursing, for any advanced practice 1
registered nurse who is: 2
a. Associated in a partnership or other business entity with a 3
physician who is already under investigation by the Kentucky 4
Board of Medical Licensure for impro per prescribing or 5
dispensing practices; 6
b. Associated in a partnership or other business entity with an 7
advanced practice registered nurse who is already under 8
investigation by the Board of Nursing for improper prescribing 9
practices; 10
c. In a designated geographic area for which a trend report indicates 11
a substantial likelihood that inappropriate prescribing or 12
dispensing may be occurring; or 13
d. In a designated geographic area for which a report on a physician 14
or another advanced practice registered nurse in that area indicates 15
a substantial likelihood that inappropriate prescribing or 16
dispensing may be occurring in that area; 17
9. A judge or a probation or parole officer administering a diversion or 18
probation program of a criminal defendant arisi ng out of a violation of 19
this chapter or of a criminal defendant who is documented by the court 20
as a substance abuser who is eligible to participate in a court -ordered 21
drug diversion or probation program; or 22
10. A medical examiner engaged in a death invest igation pursuant to KRS 23
72.026; 24
(g) The Department for Medicaid Services shall use any data or reports from the 25
system for the purpose of identifying Medicaid providers or recipients whose 26
prescribing, dispensing, or usage of controlled substances may be: 27
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1. Appropriately managed by a single outpatient pharmacy or primary care 1
physician; or 2
2. Indicative of improper, inappropriate, or illegal prescribing or 3
dispensing practices by a practitioner or drug seeking by a Medicaid 4
recipient; 5
(h) A person who receives data or any report of the system from the cabinet shall 6
not provide it to any other person or entity except as provided in this 7
subsection, in another statute, or by order of a court of competent jurisdiction 8
and only to a person or entity authorized to receive the data or the report 9
under this section, except that: 10
1. A person specified in paragraph (f)2. of this subsection who is 11
authorized to receive data or a report may share that information with 12
any other persons specified in paragraph (f)2. of t his subsection 13
authorized to receive data or a report if the persons specified in 14
paragraph (f)2. of this subsection are working on a bona fide specific 15
investigation involving a designated person. Both the person providing 16
and the person receiving the data or report under this subparagraph shall 17
document in writing each person to whom the data or report has been 18
given or received and the day, month, and year that the data or report 19
has been given or received. This document shall be maintained in a file 20
by each agency engaged in the investigation; 21
2. A representative of the Department for Medicaid Services may share 22
data or reports regarding overutilization by Medicaid recipients with a 23
board designated in paragraph (f)1. of this subsection, or with a law 24
enforcement officer designated in paragraph (f)2. of this subsection; 25
3. The Department for Medicaid Services may submit the data as evidence 26
in an administrative hearing held in accordance with KRS Chapter 13B; 27
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4. If a state licensing board as defined in KR S 218A.205 initiates formal 1
disciplinary proceedings against a licensee, and data obtained by the 2
board is relevant to the charges, the board may provide the data to the 3
licensee and his or her counsel, as part of the notice process required by 4
KRS 13B.050 , and admit the data as evidence in an administrative 5
hearing conducted pursuant to KRS Chapter 13B, with the board and 6
licensee taking all necessary steps to prevent further disclosure of the 7
data; and 8
5. A practitioner, pharmacist, or employee who obtain s data under 9
paragraph (f)5. of this subsection may share the report with the patient 10
or person authorized to act on the patient's behalf. Any practitioner, 11
pharmacist, or employee who obtains data under paragraph (f)5. of this 12
subsection may place the report in the patient's medical record, in which 13
case the individual report shall then be deemed a medical record subject 14
to disclosure on the same terms and conditions as an ordinary medical 15
record in lieu of the disclosure restrictions otherwise imposed by this 16
section; 17
(i) The cabinet, all peace officers specified in paragraph (f)2. of this subsection, 18
all officers of the court, and all regulatory agencies and officers, in using the 19
data for investigative or prosecution purposes, shall consider the nature o f the 20
prescriber's and dispenser's practice and the condition for which the patient is 21
being treated; 22
(j) Intentional failure to comply with the reporting requirements of this 23
subsection shall be a Class B misdemeanor for the first offense and a Class A 24
misdemeanor for each subsequent offense; and 25
(k) If the cabinet becomes aware of a prescriber's or dispenser's failure to comply 26
with this section, the cabinet shall notify the licensing board or agency 27
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responsible for licensing the prescriber or dispenser. The licensing board shall 1
treat the notification as a complaint against the license. 2
(4) For the purpose of monitoring the cultivation, processing, production, 3
recommending, and dispensing of medicinal cannabis: 4
(a) Every medicinal cannabis practitioner wh o is authorized pursuant to KRS 5
218B.050 to provide written certifications for the use of medicinal cannabis 6
and every cannabis business licensed under KRS 218B.080, 218B.085, and 7
218B.090 shall register with the cabinet to use the system provided for in t his 8
section and shall maintain such registration continuously during the medicinal 9
cannabis practitioner's authorization to provide written certifications or a 10
cannabis business's term of licensure and shall not have to pay a fee or tax 11
specifically dedicated to the operation of the system; 12
(b) No later than July 1, 2024, the cabinet shall ensure that the system provided 13
for in this section allows: 14
1. Medicinal cannabis practitioners to record the issuance of written 15
certifications to a patient as required by KRS 218B.050; 16
2. The cabinet, law enforcement personnel, and dispensary agents to verify 17
the validity of registry identification cards issued by the cabinet. When 18
verifying the validity of an identification card, the system shall only 19
disclose whether t he identification card is valid and whether the 20
cardholder is a registered qualified patient, visiting qualified patient, or 21
designated caregiver; 22
3. Dispensary agents to record the amount of medicinal cannabis that is 23
dispensed to a cardholder during each transaction, as required by KRS 24
218B.110; 25
4. Law enforcement personnel and dispensary agents to access medicinal 26
cannabis sales data recorded by dispensary agents pursuant to KRS 27
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218B.110; 1
5. The sharing of dispensing data recorded by dispensary agents, p ursuant 2
to KRS 218B.110, with all licensed dispensaries in real time; 3
6. Licensed cannabis businesses to record data required by administrative 4
regulations promulgated pursuant to KRS 218B.140 to facilitate the 5
tracking of medicinal cannabis from the point of cultivation to the point 6
of sale to cardholders; and 7
7. The cabinet to track all medicinal cannabis in the state from the point of 8
cultivation to the point of sale to a cardholder; 9
(c) The cabinet shall only disclose data related to the cultivation, production, 10
recommending, and dispensing of medicinal cannabis to persons and entities 11
authorized to receive that data under this subsection. Disclosure to any other 12
person or entity, including disclosure in the context of a civil action where the 13
disclosure is sought either for the purpose of discovery or for evidence, is 14
prohibited unless specifically authorized by this subsection. The cabinet shall 15
be authorized to provide data to: 16
1. Any p erson or entity authorized to receive data pursuant to paragraph 17
(b) of this subsection; 18
2. A designated representative of a state licensing board responsible for the 19
licensure, regulation, or discipline of medicinal cannabis practitioners 20
and who is invol ved in a bona fide specific investigation involving a 21
designated person; 22
3. Employees of the Office of the Inspector General of the cabinet who 23
have successfully completed training for the electronic system and who 24
have been approved to use the system, Ken tucky Commonwealth's 25
attorneys and assistant Commonwealth's attorneys, and county attorneys 26
and assistant county attorneys who are engaged in a bona fide specific 27
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investigation involving a designated person; 1
4. A properly convened grand jury pursuant to a subpoena properly issued 2
for the records; 3
5. A medicinal cannabis practitioner or an employee of a medicinal 4
cannabis practitioner's practice acting under the specific direction of the 5
medicinal cannabis practitioner, who certifies that the request for 6
information is for the purpose of complying with KRS 218B.050(4)(c); 7
6. The chief medical officer of a hospital or long -term-care facility, an 8
employee of the hospital or long -term-care facility as designated by the 9
chief medical officer and who is working un der his or her specific 10
direction, or a physician designee if the hospital or facility has no chief 11
medical officer, if the officer, employee, or designee certifies that the 12
requested information is for the purpose of providing medical or 13
pharmaceutical treatment to a bona fide current or prospective patient or 14
resident in the hospital or facility; 15
7. In addition to the purposes authorized under subparagraph 2. of this 16
paragraph, the Kentucky Board of Medical Licensure, for any physician 17
who is: 18
a. Associated in a partnership, other business entity, or supervision 19
agreement established pursuant to KRS 311.854 with a physician 20
who is already under investigation by the Board of Medical 21
Licensure for improper issuance of written certifications; 22
b. Associated in a partnership or other business entity with an 23
advanced practice registered nurse who is already under 24
investigation by the Board of Nursing for improper issuance of 25
written certifications; 26
c. In a designated geographic area for which a trend report indic ates 27
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a substantial likelihood that inappropriate issuance of written 1
certifications may be occurring; or 2
d. In a designated geographic area for which a report on another 3
physician in that area indicates a substantial likelihood that 4
inappropriate issuance of written certifications may be occurring in 5
that area; 6
8. In addition to the purposes authorized under subparagraph 2. of this 7
paragraph, the Kentucky Board of Nursing, for any advanced practice 8
registered nurse who is: 9
a. Associated in a partnership or other business entity with a 10
physician who is already under investigation by the Kentucky 11
Board of Medical Licensure for improper issuance of written 12
certifications; 13
b. Associated in a partnership or other business entity with an 14
advanced practice register ed nurse who is already under 15
investigation by the Board of Nursing for improper issuance of 16
written certifications; 17
c. In a designated geographic area for which a trend report indicates 18
a substantial likelihood that inappropriate issuance of written 19
certifications may be occurring; or 20
d. In a designated geographic area for which a report on another 21
advanced practice registered nurse in that area indicates a 22
substantial likelihood that inappropriate issuance of written 23
certifications may be occurring in that area; 24
9. A judge or a probation or parole officer administering a diversion or 25
probation program of a criminal defendant arising out of a violation of 26
this chapter or of a criminal defendant who is documented by the court 27
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as a substance abuser who is eli gible to participate in a court -ordered 1
drug diversion or probation program; 2
10. A medical examiner engaged in a death investigation pursuant to KRS 3
72.026; or 4
11. The Legislative Research Commission, the University of Kentucky 5
College of Medicine, or the Kentucky Center for Cannabis established 6
in KRS 164.983 if the cabinet determines that disclosing data related to 7
the cultivation, production, recommending, and dispensing of medicinal 8
cannabis to the Legislative Research Commission, the University of 9
Kentucky College of Medicine, or the Kentucky Center for Cannabis is 10
necessary to comply with the reporting requirements established in KRS 11
218B.020(8); and 12
(d) A person who receives data or any report of the system from the cabinet shall 13
not provide it to any other person or entity except as provided in this section, 14
in another statute, or by order of a court of competent jurisdiction and only to 15
a person or entity authorized to receive the data or the report under this 16
section, except that: 17
1. A person specif ied in paragraph (c)3. of this subsection who is 18
authorized to receive data or a report may share that information with 19
any other persons specified in paragraph (c)3. of this subsection 20
authorized to receive data or a report if the persons specified in 21
paragraph (c)3. of this subsection are working on a bona fide specific 22
investigation involving a designated person. Both the person providing 23
and the person receiving the data or report under this subparagraph shall 24
document in writing each person to whom the data or report has been 25
given or received and the day, month, and year that the data or report 26
has been given or received. This document shall be maintained in a file 27
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by each agency engaged in the investigation; 1
2. If a state licensing board initiates for mal disciplinary proceedings 2
against a licensee, and data obtained by the board is relevant to the 3
charges, the board may provide the data to the licensee and his or her 4
counsel, as part of the notice process required by KRS 13B.050, and 5
admit the data as evidence in an administrative hearing conducted 6
pursuant to KRS Chapter 13B, with the board and licensee taking all 7
necessary steps to prevent further disclosure of the data; and 8
3. A medicinal cannabis practitioner or an employee of a medicinal 9
cannabis practitioner's practice acting under the specific direction of the 10
medicinal cannabis practitioner who obtains data under paragraph (c)5. 11
of this subsection may share the report with the patient or person 12
authorized to act on the patient's behalf. Any medic inal cannabis 13
practitioner or employee who obtains data under paragraph (c)5. of this 14
subsection may place the report in the patient's medical record, in which 15
case the individual report shall then be deemed a medical record subject 16
to disclosure on the sa me terms and conditions as an ordinary medical 17
record in lieu of the disclosure restrictions otherwise imposed by this 18
section. 19
(5) The data contained in, and any report obtained from, the electronic system for 20
monitoring established pursuant to this secti on shall not be a public record, except 21
that the Department for Medicaid Services may submit the data as evidence in an 22
administrative hearing held in accordance with KRS Chapter 13B. 23
(6) Intentional disclosure of transmitted data to a person not authorize d by subsection 24
(3)(f) to (h) or (4)(c) and (d) of this section or authorized by KRS 315.121, or 25
obtaining information under this section not relating to a bona fide current or 26
prospective patient or a bona fide specific investigation, shall be a Class B 27
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misdemeanor for the first offense and a Class A misdemeanor for each subsequent 1
offense. 2
(7) The cabinet may, by promulgating an administrative regulation, limit the length of 3
time that data remain in the electronic system. Any data removed from the system 4
shall be archived and subject to retrieval within a reasonable time after a request 5
from a person authorized to review data under this section. 6
(8) (a) The Cabinet for Health and Family Services shall work with each board 7
responsible for the licensure, regulation, or discipline of practitioners, 8
pharmacists, or other persons who are authorized to prescribe, administer, or 9
dispense controlled substances for the development of a continuing education 10
program about the purposes and uses of the electronic system for monitoring 11
established in this section. 12
(b) The cabinet shall work with each board resp onsible for the licensure, 13
regulation, or discipline of medicinal cannabis practitioners for the 14
development of a continuing education program about the purposes and uses 15
of the electronic system for monitoring established in this section. 16
(c) The cabinet shall work with the Kentucky Bar Association for the 17
development of a continuing education program for attorneys about the 18
purposes and uses of the electronic system for monitoring established in this 19
section. 20
(d) The cabinet shall work with the Justice an d Public Safety Cabinet for the 21
development of a continuing education program for law enforcement officers 22
about the purposes and uses of the electronic system for monitoring 23
established in this section. 24
(e) The cabinet shall develop a training program for cannabis business agents 25
about the purposes and uses of the electronic system for monitoring 26
established in this section. 27
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(9) The cabinet, Office of Inspector General, shall conduct quarterly reviews to identify 1
patterns of potential improper, inappropria te, or illegal prescribing or dispensing of 2
a controlled substance, issuance of written certifications, or cultivation, processing, 3
or dispensing of medicinal cannabis. The Office of Inspector General may 4
independently investigate and submit findings and r ecommendations to the 5
appropriate boards of licensure or other reporting agencies. 6
(10) The cabinet shall promulgate administrative regulations in accordance with KRS 7
Chapter 13A to implement the provisions of this section. Included in these 8
administrative regulations shall be: 9
(a) An error resolution process allowing a patient to whom a report had been 10
disclosed under subsections (3) and (4) of this section to request the correction 11
of inaccurate information contained in the system relating to that patient; and 12
(b) A requirement that data be reported to the system under subsection (3)(b) of 13
this section within one (1) day of dispensing. 14
(11) (a) Before July 1, 2018, the Administrative Office of the Courts shall forward 15
data regarding any felony or Class A m isdemeanor conviction that involves 16
the trafficking or possession of a controlled substance or other prohibited acts 17
under KRS Chapter 218A for the previous five (5) calendar years to the 18
cabinet for inclusion in the electronic monitoring system establishe d under 19
this section. On or after July 1, 2018, such data shall be forwarded by the 20
Administrative Office of the Courts to the cabinet on a continuing basis. The 21
cabinet shall incorporate the data received into the system so that a query by 22
patient name indicates any prior drug conviction. 23
(b) Before July 1, 2024, the Administrative Office of the Courts shall forward all 24
available data regarding any disqualifying felony offense for the previous five 25
(5) calendar years to the cabinet for inclusion in the ele ctronic monitoring 26
system established under this section. On or after July 1, 2024, such data shall 27
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be forwarded by the Administrative Office of the Courts to the cabinet on a 1
continuing basis. The cabinet shall incorporate the data received into the 2
system so that a query by patient name indicates any prior disqualifying 3
felony conviction. 4
Section 6. KRS 218A.205 is amended to read as follows: 5
(1) As used in this section: 6
(a) "Reporting agency" includes: 7
1. The Department of Kentucky State Police; 8
2. The Office of the Attorney General; 9
3. The Cabinet for Health and Family Services; and 10
4. The applicable state licensing board; and 11
(b) "State licensing board" means: 12
1. The Kentucky Board of Medical Licensure; 13
2. The Kentucky Board of Nursing; 14
3. The Kentucky Board of Dentistry; 15
4. The Kentucky Board of Optometric Examiners; 16
5. The State Board of Podiatry; and 17
6. Any other board that licenses or regulates a person who is entitled to 18
prescribe or dispense controlled substances to humans. 19
(2) (a) When a reporting agency or a law enforcement agency receives a report of 20
improper, inappropriate, or illegal prescribing o r dispensing of a controlled 21
substance it may, to the extent otherwise allowed by law, send a copy of the 22
report within three (3) business days to every other reporting agency. 23
(b) A county attorney or Commonwealth's attorney shall notify the Office of the 24
Attorney General and the appropriate state licensing board within three (3) 25
business days of an indictment or a waiver of indictment becoming public in 26
his or her jurisdiction charging a licensed person with a felony offense 27
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relating to the manufacture of , trafficking in, prescribing, dispensing, or 1
possession of a controlled substance. 2
(3) Each state licensing board shall, in consultation with the Kentucky Office of Drug 3
Control Policy, establish the following by administrative regulation for those 4
licensees authorized to prescribe or dispense controlled substances: 5
(a) Mandatory prescribing and dispensing standards related to controlled 6
substances, the requirements of which shall include the diagnostic, treatment, 7
review, and other protocols and standards established for Schedule II 8
controlled substances [and Schedule III controlled substances containing 9
hydrocodone ]under KRS 218A.172 and which may include the exemptions 10
authorized by KRS 218A.172(4); 11
(b) In accord with the CDC Guideline for Prescribing O pioids for Chronic Pain 12
published in 2016, a prohibition on a practitioner issuing a prescription for a 13
Schedule II controlled substance for more than a three (3) day supply of a 14
Schedule II controlled substance if the prescription is intended to treat pai n as 15
an acute medical condition, with the following exceptions: 16
1. The practitioner, in his or her professional judgment, believes that more 17
than a three (3) day supply of a Schedule II controlled substance is 18
medically necessary to treat the patient's pai n as an acute medical 19
condition and the practitioner adequately documents the acute medical 20
condition and lack of alternative treatment options which justifies 21
deviation from the three (3) day supply limit established in this 22
subsection in the patient's medical records; 23
2. The prescription for a Schedule II controlled substance is prescribed to 24
treat chronic pain; 25
3. The prescription for a Schedule II controlled substance is prescribed to 26
treat pain associated with a valid cancer diagnosis; 27
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4. The prescription for a Schedule II controlled substance is prescribed to 1
treat pain while the patient is receiving hospice or end -of-life treatment 2
or is receiving care from a certified community based palliative care 3
program; 4
5. The prescription for a Schedule II cont rolled substance is prescribed as 5
part of a narcotic treatment program licensed by the Cabinet for Health 6
and Family Services; 7
6. The prescription for a Schedule II controlled substance is prescribed to 8
treat pain following a major surgery or the treatment of significant 9
trauma, as defined by the state licensing board in consultation with the 10
Kentucky Office of Drug Control Policy; 11
7. The Schedule II controlled substance is dispensed or administered 12
directly to an ultimate user in an inpatient setting; or 13
8. Any additional treatment scenario deemed medically necessary by the 14
state licensing board in consultation with the Kentucky Office of Drug 15
Control Policy. 16
Nothing in this paragraph shall authorize a state licensing board to promulgate 17
regulations which expand any practitioner's prescriptive authority beyond that 18
which existed prior to June 29, 2017; 19
(c) A prohibition on a practitioner dispensing greater than a forty -eight (48) hour 20
supply of any Schedule II controlled substance [or a Schedule III control led 21
substance containing hydrocodone ] unless the dispensing is done as part of a 22
narcotic treatment program licensed by the Cabinet for Health and Family 23
Services; 24
(d) A procedure for temporarily suspending, limiting, or restricting a license held 25
by a nam ed licensee where a substantial likelihood exists to believe that the 26
continued unrestricted practice by the named licensee would constitute a 27
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danger to the health, welfare, or safety of the licensee's patients or of the 1
general public; 2
(e) A procedure for the expedited review of complaints filed against their 3
licensees pertaining to the improper, inappropriate, or illegal prescribing or 4
dispensing of controlled substances that is designed to commence an 5
investigation within seven (7) days of a complaint be ing filed and produce a 6
charging decision by the board on the complaint within one hundred twenty 7
(120) days of the receipt of the complaint, unless an extension for a definite 8
period of time is requested by a law enforcement agency due to an ongoing 9
criminal investigation; 10
(f) The establishment and enforcement of licensure standards that conform to the 11
following: 12
1. A permanent ban on licensees and applicants convicted after July 20, 13
2012, in this state or any other state of any felony offense relating to 14
controlled substances from prescribing or dispensing a controlled 15
substance; 16
2. Restrictions short of a permanent ban on licensees and applicants 17
convicted in this state or any other state of any misdemeanor offense 18
relating to prescribing or dispensing a controlled substance; 19
3. Restrictions mirroring in time and scope any disciplinary limitation 20
placed on a licensee or applicant by a licensing board of another state if 21
the disciplinary action results from improper, inappropriate, or illegal 22
prescribing or dispensing of controlled substances; and 23
4. A requirement that licensees and applicants report to the board any 24
conviction or disciplinary action covered by this subsection with 25
appropriate sanctions for any failure to make this required report; 26
(g) A pro cedure for the continuous submission of all disciplinary and other 27
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reportable information to the National Practitioner Data Bank of the United 1
States Department of Health and Human Services; 2
(h) If not otherwise required by other law, a process for submitt ing a query on 3
each applicant for licensure to the National Practitioner Data Bank of the 4
United States Department of Health and Human Services to retrieve any 5
relevant data on the applicant; and 6
(i) Continuing education requirements beginning with the fir st full educational 7
year occurring after July 1, 2012, that specify that at least seven and one -half 8
percent (7.5%) of the continuing education required of the licensed 9
practitioner relate to the use of the electronic monitoring system established in 10
KRS 218A.202, pain management, or addiction disorders. 11
(4) For the purposes of pharmacy dispensing, the medical necessity for a Schedule II 12
controlled substance as documented by the practitioner in the patient's medical 13
record and the prescription for more than a three (3) day supply of that controlled 14
substance are presumed to be valid. 15
(5) A state licensing board shall employ or obtain the services of a specialist in the 16
treatment of pain and a specialist in drug addiction to evaluate information received 17
regarding a licensee's prescribing or dispensing practices related to controlled 18
substances if the board or its staff does not possess such expertise, to ascertain if the 19
licensee under investigation is engaging in improper, inappropriate, or illegal 20
practices. 21
(6) Any statute to the contrary notwithstanding, no state licensing board shall require 22
that a grievance or complaint against a licensee relating to controlled substances be 23
sworn to or notarized, but the grievance or complaint shall identify the name and 24
address of the grievant or complainant, unless the b oard by administrative 25
regulation authorizes the filing of anonymous complaints. Any such authorizing 26
administrative regulation shall require that an anonymous complaint or grievance be 27
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accompanied by sufficient corroborating evidence as would allow the bo ard to 1
believe, based upon a totality of the circumstances, that a reasonable probability 2
exists that the complaint or grievance is meritorious. 3
(7) Every state licensing board shall cooperate to the maximum extent permitted by law 4
with all state, local, a nd federal law enforcement agencies, and all professional 5
licensing boards and agencies, state and federal, in the United States or its 6
territories in the coordination of actions to deter the improper, inappropriate, or 7
illegal prescribing or dispensing of a controlled substance. 8
(8) Each state licensing board shall require a fingerprint -supported criminal record 9
check by the Department of Kentucky State Police and the Federal Bureau of 10
Investigation of any applicant for initial licensure to practice any pr ofession 11
authorized to prescribe or dispense controlled substances. 12
Section 7. KRS 218A.245 is amended to read as follows: 13
(1) The secretary of the Cabinet for Health and Family Services may enter into 14
reciprocal agreements or a contract, either directly with any federal agency of the 15
United States or its territories, any other state or states of the United States or any 16
jurisdiction, county, or political subdivision thereof, or with an organization 17
administering the exch ange of interstate data on behalf of the prescription 18
monitoring program of one (1) or more states or jurisdictions, to share prescription 19
drug monitoring information if the other prescription drug monitoring program or 20
data exchange program is compatible with the program in Kentucky. If the 21
secretary elects to evaluate the prescription drug monitoring program of another 22
state, jurisdiction, or organization as authorized by this section, priority shall be 23
given to a state or jurisdiction that is contiguous with the borders of the 24
Commonwealth or an organization that offers connectivity with a contiguous state 25
or jurisdiction. 26
(2) In determining compatibility, the secretary shall consider: 27
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(a) The essential purposes of the program and the success of the progr am in 1
fulfilling those purposes; 2
(b) The safeguards for privacy of patient records and its success in protecting 3
patient privacy; 4
(c) The persons authorized to view the data collected by the program; 5
(d) The schedules of controlled substances monitored; 6
(e) The data required to be submitted on each prescription or dispensing; 7
(f) Any implementation criteria deemed essential for a thorough comparison; and 8
(g) The costs and benefits to the Commonwealth in mutually sharing particular 9
information available in t he Commonwealth's database with the program 10
under consideration. 11
(3) The secretary shall review any agreement on an annual basis to determine its 12
continued compatibility with the Kentucky prescription drug monitoring program. 13
(4) Any agreement between the cabinet and another state, jurisdiction, or organization 14
shall prohibit the sharing of information about a Kentucky resident, practitioner, 15
pharmacist, or other prescriber or dispenser for any purpose not otherwise 16
authorized by this section or KRS 218A.202. 17
Section 8. KRS 304.17A-165 is amended to read as follows: 18
(1) Any health benefit plan that provides benefits for prescription drugs shall include an 19
exceptions policy or an override policy that provides coverage for t he refill of a 20
covered drug dispensed prior to the expiration of the insured's supply of the drug. 21
The insurer shall provide notice in existing written or electronic communications to 22
pharmacies doing business with the insurer, the pharmacy benefit manager if 23
applicable, and to the insured regarding the exceptions policy or override policy. 24
This subsection shall not apply to controlled substances as classified by KRS 25
Chapter 218A. 26
(2) Nothing in this section shall prohibit an insurer from limiting payment t o no more 27
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than three (3) refills of a covered drug in a ninety (90) day period. 1
(3) Any individual or group health benefit plan that provides benefits for prescription 2
drugs shall provide a program for synchronization of medications when it is agreed 3
among the insured, a provider, and a pharmacist that synchronization of multiple 4
prescriptions for the treatment of a chronic illness is in the best interest of the 5
patient for the management or treatment of a chronic illness provided that the 6
medications: 7
(a) Are covered by the individual or group health benefit plan: 8
(b) Are used for treatment and management of chronic conditions that are subject 9
to refills; 10
(c) Are not a Schedule II controlled substance [ or a Schedule III controlled 11
substance containing hydrocodone]; 12
(d) Meet all prior authorization criteria specific to the medications at the time of 13
the synchronization request; 14
(e) Are of a formulation that can be effectively split over required short fill 15
periods to achieve synchronization; and 16
(f) Do not have quantity limits or dose optimization criteria or requirements that 17
would be violated in fulfilling synchronization. 18
(4) To permit synchronization, an individual or group health benefit plan shall apply a 19
prorated daily cost -sharing rate to any medicatio n dispensed by a network 20
pharmacy pursuant to this section. 21
(5) Any dispensing fee shall not be prorated and shall be based on an individual 22
prescription filled or refilled. 23