KRS 304.17A-163: Definitions for KRS 304.17A -163 and 304.17A -1631 -- Establishment

of clinical review criteria -- Override of restrictions on medication sequence in

step therapy or fail-first protocol.

(1) As used in this section and KRS 304.17A -1631, unless the context requires

otherwise:

(a) "Clinical practice guidelines" means a systematically developed statement to

assist decision making by health care providers and patients about appropriate

healthcare for specific clinical circumstances and conditions;

(b) "Clinical review criteria" means the written screening procedures, decision

abstracts, clinical protocols, and clinical practice guidelines used by the

insurer, health plan, pharmacy benefit manager, or private review agent to

determine the medical necessity and appropriateness of health care services;

(c) "Health plan":

1. Means any state-regulated policy, certificate, contract, or plan that offers

or provides coverage in this state, by direct payment, reimbursement, or

otherwise, for prescrip tion drugs pursuant to a step therapy protocol,

regardless of whether the protocol is described as a step therapy

protocol; and

2. Shall include but not be limited to a health benefit plan;

(d) "Pharmacy benefit manager" has the same meaning as in KRS 304.9-020;

(e) "Private review agent" has the same meaning as in KRS 304.17A-600;

(f) "Step therapy exception" means a determination that a step therapy protocol

should be overridden in favor of immediate coverage of the health care

provider's selected prescription drug; and

(g) "Step therapy protocol" means a protocol, policy, or program t hat establishes

the specific sequence in which prescription drugs that are for a specified

medical condition and medically appropriate for a particular insured are

covered by an insurer or health plan.

(2) (a) Except as provided in paragraph (b) of this su bsection, clinical review criteria

developed by an insurer, health plan, pharmacy benefit manager, or private

review agent to establish a step therapy protocol shall be based on clinical

practice guidelines that:

1. Recommend that prescription drugs be tak en in the specific sequence

required by the step therapy protocol;

2. Are developed and endorsed by a multidisciplinary panel of experts that

manages conflicts of interest among the members of the writing and

review groups by:

a. Requiring members to:

i. Disclose any potential conflict of interests with entities,

including insurers, health plans, and pharmaceutical

manufacturers; and

ii. Recuse himself or herself from voting if the member has a

conflict of interest;

b. Using a methodologist to work with wri ting groups to provide

objectivity in data analysis and ranking of evidence through the

preparation of evidence tables and facilitating consensus; and

c. Offering opportunities for public review and comments;

3. Are based on high quality studies, research, and medical practice;

4. Are created by an explicit and transparent process that:

a. Minimizes biases and conflicts of interest;

b. Explains the relationship between treatment options and outcomes;

c. Rates the quality of the evidence supporting recommend ations;

and

d. Considers relevant patient subgroups and preferences; and

5. Are continually updated through a review of new evidence, research,

and newly developed treatments.

(b) In the absence of clinical practice guidelines that meet the requirements of

paragraph (a) of this subsection, an insurer, health plan, pharmacy benefit

manager, or private review agent may use peer -reviewed publications to

establish step therapy protocols.

(c) When establishing clinical review criteria for a step therapy protocol , an

insurer, health plan, pharmacy benefit manager, or private review agent shall

take into account the needs of atypical patient populations and diagnoses.

(d) 1. An insurer, health plan, pharmacy benefit manager, or private review

agent shall, upon writ ten request, provide all specific written clinical

review criteria relating to a particular condition or disease, including

clinical review criteria relating to a step therapy exception

determination.

2. The clinical review criteria and other clinical info rmation shall be made

available:

a. On the insurer's, health plan's, pharmacy benefit manager's, or

private review agent's website; and

b. To a health care professional on behalf of an insured upon written

request.

(e) Nothing in this subsection shall be construed to require an insurer, health plan,

pharmacy benefit manager, or private review agent to establish a new entity to

develop clinical review criteria used for step therapy protocols.

(3) (a) When coverage of a prescription drug for the treatment of any medical

condition is restricted for use by an insurer, health plan, private review agent,

or a pharmacy benefit manager by a step therapy protocol, the insured and

prescribing provider shall hav e access to a clear, readily accessible, and

convenient process to request a step therapy exception.

(b) An insurer, health plan, private review agent, or pharmacy benefit manager:

1. May use its existing medical exceptions process to satisfy the

requirements of paragraph (a) of this subsection;

2. Shall make the step therapy protocol easily accessible on its website;

and

3. Shall, upon request, disclose all rules and criteria related to the step

therapy protocol to all prescribing providers, including the specific

information and documentation that must be submitted by a prescribing

provider or insured to be considered a complete request for a step

therapy exception.

(4) (a) A step therapy exception request, or an internal appeal under KRS 304.17A -

617 of a step therapy exception request denial, shall be granted by the insurer,

health plan, private review agent, or the pharmacy benefit manager within

forty-eight (48) hours if:

1. All necessary information to perform the step therapy exception review,

or make the appeal determination, has been provided; and

2. One (1) of the following apply:

a. The required prescription drug is:

i. Contraindicated or will likely cause an adverse reaction by

physical or mental harm to the insured; or

ii. Expected to be ineffecti ve based on the known clinical

characteristics of the insured and the prescription drug

regimen;

b. Based on clinical appropriateness, the required prescription drug is

not in the best interest of the insured because the insured's use of

the required prescription drug is expected to:

i. Cause a significant barrier to the insured's adherence to or

compliance with the insured's plan of care;

ii. Worsen a comorbid condition of the insured; or

iii. Decrease the insured's ability to achieve or maintain

reasonable functional ability in performing daily activities;

c. The insured has tried the required prescription drug while under

the insured's current or a previous health plan, or another

prescription drug in the same pharmacologic class or with the

same mechanis m of action, and the prescription drug was

discontinued due to lack of efficacy or effectiveness, diminished

effect, or an adverse event; or

d. The insured is stable on the prescription drug selected by the

insured's health care provider for the medical co ndition under

consideration while under a current or previous health plan.

(b) If a request for a step therapy exception, or an internal appeal under KRS

304.17A-617 of a step therapy exception request denial, is incomplete or

additional clinically relevan t information is required, the insurer, health plan,

pharmacy benefit manager, or private review agent shall notify the prescribing

provider within forty-eight (48) hours of submission of the request or appeal:

1. That the request or appeal is incomplete; and

2. What additional or clinically relevant information is required in order to

approve or deny the step therapy exception.

(5) If a step therapy exception request determination, notification under subsection

(4)(b) of this section, or internal appeal determination under KRS 304.17A-617 of a

step therapy exception request denial by an insurer, health plan, pharmacy benefit

manager, or private review agent is not received by the prescribing provider within

the time period specified in subsection (4) of this section, the step therapy exception

request or internal appeal shall be deemed granted.

(6) An insured or a provider may:

(a) Initiate an internal appeal under KRS 304.17A -617 upon the denial of a step

therapy exception request under this section; and

(b) Request an external review under KRS 304.17A -623 upon the denial of an

internal appeal under paragraph (a) of this subsection.

(7) An insurer, health plan, pharmacy benefit manager, or private review agent shall:

(a) Upon the granting of a step therapy exception request, internal appeal, or

external review, authorize coverage for the prescription drug selected by the

insured's health care provider; or

(b) Upon the denial of a step therapy exception request or internal appeal, inform

the insured of the internal appeal or external review process, as applicable.

(8) (a) Except as provided in paragraph (b) of this subsection, the duration of any

step therapy protocol shall not be longer than a period of thirty (30) days if the

treatment is deemed and documented as clinically ineffective by the

prescribing provider.

(b) When the prescribing provider can demonstrate, through sound clinical

evidence, that the originally prescribed medication is likely to require more

than thirty (30) days to provide any relief or an amelioration to the insured,

the step therapy protocol may be extended up to seven (7) additional days.

(9) Nothing in this section shall be construed to prevent:

(a) An insurer, health plan, pharmacy benefit manager, or private review agent

from requiring an insured to try:

1. An AB -rated generic equivalent prior to providing coverage for the

reference listed drug;

2. An interchange able biological product, as defined in 42 U.S.C. sec.

262(i)(3), prior to providing coverage for the reference product; or

3. A biosimilar biological product, as defined in 42 U.S.C. sec. 262(i)(2),

prior to providing coverage for the reference product;

unless the requirement meets any of the criteria set forth in subsection (4)(a)2.

of this section pursuant to a step therapy exception request submitted under

subsection (4) of this section;

(b) An insurer, health plan, pharmacy benefit manager, or private review agent

from requiring a pharmacist to effect substitutions of prescription drugs

consistent with KRS 217.814 to 217.896 and 304.17A-535; or

(c) A health care provider from prescribing a prescription drug that is determined

to be medically appropriate.