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AN ACT relating to biosimilar medicines. 1
Be it enacted by the General Assembly of the Commonwealth of Kentucky: 2
Section 1. KRS 304.17A-163 is amended to read as follows: 3
(1) As used in this section and KRS 304.17A-1631, unless the context requires 4
otherwise: 5
(a) "Clinical practice guidelines" means a systematically developed statement to 6
assist decision making by health care providers and patients about appropriate 7
healthcare for specific clinical circumstances and conditions; 8
(b) "Clinical review criteria" means the written screening procedures, decision 9
abstracts, clinical protocols, and clinical practice guidelines used by the 10
insurer, health plan, pharmacy benefit manager, or private review agent to 11
determine the medical necessity and appropriateness of health care services; 12
(c) "Health plan": 13
1. Means any state-regulated policy, certificate, contract, or plan that offers 14
or provides coverage in this state, by direct payment, reimbursement, or 15
otherwise, for prescription drugs pursuant to a step therapy protocol, 16
regardless of whether the protocol is described as a step therapy 17
protocol; and 18
2. Shall include but not be limited to a health benefit plan; 19
(d) "Pharmacy benefit manager" has the same meaning as in KRS 304.9-020; 20
(e) "Private review agent" has the same meaning as in KRS 304.17A-600; 21
(f) "Step therapy exception" means a determination that a step therapy protocol 22
should be overridden in favor of immediate coverage of the health care 23
provider's selected prescription drug; and 24
(g) "Step therapy protocol" means a protocol, policy, or program that establishes 25
the specific sequence in which prescription drugs that are for a specified 26
medical condition and medically appropriate for a particular insured are 27 UNOFFICIAL COPY 24 RS BR 980
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covered by an insurer or health plan. 1
(2) (a) Except as provided in paragraph (b) of this subsection, clinical review criteria 2
developed by an insurer, health plan, pharmacy benefit manager, or private 3
review agent to establish a step therapy protocol shall be based on clinical 4
practice guidelines that: 5
1. Recommend that prescription drugs be taken in the specific sequence 6
required by the step therapy protocol; 7
2. Are developed and endorsed by a multidisciplinary panel of experts that 8
manages conflicts of interest among the members of the writing and 9
review groups by: 10
a. Requiring members to: 11
i. Disclose any potential conflict of interests with entities, 12
including insurers, health plans, and pharmaceutical 13
manufacturers; and 14
ii. Recuse himself or herself from voting if the member has a 15
conflict of interest; 16
b. Using a methodologist to work with writing groups to provide 17
objectivity in data analysis and ranking of evidence through the 18
preparation of evidence tables and facilitating consensus; and 19
c. Offering opportunities for public review and comments; 20
3. Are based on high quality studies, research, and medical practice; 21
4. Are created by an explicit and transparent process that: 22
a. Minimizes biases and conflicts of interest; 23
b. Explains the relationship between treatment options and outcomes; 24
c. Rates the quality of the evidence supporting recommendations; 25
and 26
d. Considers relevant patient subgroups and preferences; and 27 UNOFFICIAL COPY 24 RS BR 980
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5. Are continually updated through a review of new evidence, research, 1
and newly developed treatments. 2
(b) In the absence of clinical practice guidelines that meet the requirements of 3
paragraph (a) of this subsection, an insurer, health plan, pharmacy benefit 4
manager, or private review agent may use peer-reviewed publications to 5
establish step therapy protocols. 6
(c) When establishing clinical review criteria for a step therapy protocol, an 7
insurer, health plan, pharmacy benefit manager, or private review agent shall 8
take into account the needs of atypical patient populations and diagnoses. 9
(d) 1. An insurer, health plan, pharmacy benefit manager, or private review 10
agent shall, upon written request, provide all specific written clinical 11
review criteria relating to a particular condition or disease, including 12
clinical review criteria relating to a step therapy exception 13
determination. 14
2. The clinical review criteria and other clinical information shall be made 15
available: 16
a. On the insurer's, health plan's, pharmacy benefit manager's, or 17
private review agent's website[Web site]; and 18
b. To a health care professional on behalf of an insured upon written 19
request. 20
(e) Nothing in this subsection shall be construed to require an insurer, health plan, 21
pharmacy benefit manager, or private review agent to establish a new entity to 22
develop clinical review criteria used for step therapy protocols. 23
(3) (a) When coverage of a prescription drug for the treatment of any medical 24
condition is restricted for use by an insurer, health plan, private review agent, 25
or a pharmacy benefit manager by a step therapy protocol, the insured and 26
prescribing provider shall have access to a clear, readily accessible, and 27 UNOFFICIAL COPY 24 RS BR 980
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convenient process to request a step therapy exception. 1
(b) An insurer, health plan, private review agent, or pharmacy benefit manager: 2
1. May use its existing medical exceptions process to satisfy the 3
requirements of paragraph (a) of this subsection; 4
2. Shall make the step therapy protocol easily accessible on its 5
website[Web site]; and 6
3. Shall, upon request, disclose all rules and criteria related to the step 7
therapy protocol to all prescribing providers, including the specific 8
information and documentation that must be submitted by a prescribing 9
provider or insured to be considered a complete request for a step 10
therapy exception. 11
(4) (a) A step therapy exception request, or an internal appeal under KRS 304.17A-12
617 of a step therapy exception request denial, shall be granted by the insurer, 13
health plan, private review agent, or the pharmacy benefit manager within 14
forty-eight (48) hours if: 15
1. All necessary information to perform the step therapy exception review, 16
or make the appeal determination, has been provided; and 17
2. One (1) of the following apply: 18
a. The required prescription drug is: 19
i. Contraindicated or will likely cause an adverse reaction by 20
physical or mental harm to the insured; or 21
ii. Expected to be ineffective based on the known clinical 22
characteristics of the insured and the prescription drug 23
regimen; 24
b. Based on clinical appropriateness, the required prescription drug is 25
not in the best interest of the insured because the insured's use of 26
the required prescription drug is expected to: 27 UNOFFICIAL COPY 24 RS BR 980
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i. Cause a significant barrier to the insured's adherence to or 1
compliance with the insured's plan of care; 2
ii. Worsen a comorbid condition of the insured; or 3
iii. Decrease the insured's ability to achieve or maintain 4
reasonable functional ability in performing daily activities; 5
c. The insured has tried the required prescription drug while under 6
the insured's current or a previous health plan, or another 7
prescription drug in the same pharmacologic class or with the 8
same mechanism of action, and the prescription drug was 9
discontinued due to lack of efficacy or effectiveness, diminished 10
effect, or an adverse event; or 11
d. The insured is stable on the prescription drug selected by the 12
insured's health care provider for the medical condition under 13
consideration while under a current or previous health plan. 14
(b) If a request for a step therapy exception, or an internal appeal under KRS 15
304.17A-617 of a step therapy exception request denial, is incomplete or 16
additional clinically relevant information is required, the insurer, health plan, 17
pharmacy benefit manager, or private review agent shall notify the prescribing 18
provider within forty-eight (48) hours of submission of the request or appeal: 19
1. That the request or appeal is incomplete; and 20
2. What additional or clinically relevant information is required in order to 21
approve or deny the step therapy exception. 22
(5) If a step therapy exception request determination, notification under subsection 23
(4)(b) of this section, or internal appeal determination under KRS 304.17A-617 of a 24
step therapy exception request denial by an insurer, health plan, pharmacy benefit 25
manager, or private review agent is not received by the prescribing provider within 26
the time period specified in subsection (4) of this section, the step therapy exception 27 UNOFFICIAL COPY 24 RS BR 980
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request or internal appeal shall be deemed granted. 1
(6) An insured or a provider may: 2
(a) Initiate an internal appeal under KRS 304.17A-617 upon the denial of a step 3
therapy exception request under this section; and 4
(b) Request an external review under KRS 304.17A-623 upon the denial of an 5
internal appeal under paragraph (a) of this subsection. 6
(7) An insurer, health plan, pharmacy benefit manager, or private review agent shall: 7
(a) Upon the granting of a step therapy exception request, internal appeal, or 8
external review, authorize coverage for the prescription drug selected by the 9
insured's health care provider; or 10
(b) Upon the denial of a step therapy exception request or internal appeal, inform 11
the insured of the internal appeal or external review process, as applicable. 12
(8) (a) Except as provided in paragraph (b) of this subsection, the duration of any 13
step therapy protocol shall not be longer than a period of thirty (30) days if the 14
treatment is deemed and documented as clinically ineffective by the 15
prescribing provider. 16
(b) When the prescribing provider can demonstrate, through sound clinical 17
evidence, that the originally prescribed medication is likely to require more 18
than thirty (30) days to provide any relief or an amelioration to the insured, 19
the step therapy protocol may be extended up to seven (7) additional days. 20
(9) Nothing in this section shall be construed to prevent: 21
(a) An insurer, health plan, pharmacy benefit manager, or private review agent 22
from requiring: 23
1. An insured to try an AB-rated generic equivalent,[ or] an 24
interchangeable biological product, as defined in 42 U.S.C. sec. 25
262(i)(3), or a biosimilar biological product, as defined 42 U.S.C. sec. 26
262(i)(2), prior to providing coverage for the equivalent branded 27 UNOFFICIAL COPY 24 RS BR 980
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prescription drug, unless the requirement meets any of the criteria set 1
forth in subsection (4)(a)2. of this section pursuant to a step therapy 2
exception request submitted under subsection (4) of this section; or 3
2. A pharmacist to effect substitutions of prescription drugs consistent with 4
KRS 217.814 to 217.896 and 304.17A-535; or 5
(b) A health care provider from prescribing a prescription drug that is determined 6
to be medically appropriate. 7
Section 2. The General Assembly finds that increased access to biosimilar 8
medicines has the potential to significantly reduce prescription drug costs. Biosimilar 9
medicines are approved according to the same United States Food and Drug 10
Administration standards of pharmaceutical quality, safety, and efficacy as their reference 11
medications. Therefore, it is the intent of this Act to eliminate barriers impeding access to 12
biosimilar medicines and the savings they can provide. 13