HF 2342

as introduced - 90th Legislature (2017 - 2018) Posted on 03/13/2017 01:47pm

A bill for an act
relating to health insurance; regulating the use of step therapy for the coverage of
prescription drugs; proposing coding for new law in Minnesota Statutes, chapter
62Q.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

new text begin [62Q.183] STEP THERAPY OVERRIDE.
new text end

new text begin Subdivision 1. new text end

new text begin Definitions. new text end

new text begin (a) For purposes of this section, the terms in paragraphs (b)
through (f) have the meanings given.
new text end

new text begin (b) "Clinical practice guideline" means a systematically developed statement to assist
health care providers and patients in making decisions about appropriate health care for
specific clinical circumstances and conditions.
new text end

new text begin (c) "Clinical review criteria" means the written screening procedures, decision abstracts,
clinical protocols, and clinical practice guidelines used by the plan sponsor to determine
the medical necessity and appropriateness of health care services.
new text end

new text begin (d) "Plan sponsor" means a health plan company or a utilization review organization as
defined in section 62M.02, subdivision 21.
new text end

new text begin (e) "Step therapy protocol" means a protocol or program that establishes the specific
sequence in which prescription drugs for a specified medical condition, including
self-administered and physician-administered drugs, are medically appropriate for a particular
patient and are covered under a health plan.
new text end

new text begin (f) "Step therapy override" means that the step therapy protocol should be overridden
in favor of immediate coverage of the health care provider's selected prescription drug. A
step therapy override is granted upon the prescriber's request, but may be appealed by the
plan sponsor in accordance with subdivision 3.
new text end

new text begin Subd. 2. new text end

new text begin Criteria for step therapy protocols. new text end

new text begin (a) Clinical review criteria used by a plan
sponsor to establish a step therapy protocol shall be based on clinical practice guidelines
that:
new text end

new text begin (1) recommend that the prescription drugs be taken in the specific sequence required by
the step therapy protocol;
new text end

new text begin (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:
new text end

new text begin (i) requiring members to disclose any potential conflict of interest with entities including
health plan companies and pharmaceutical manufacturers and recuse themselves of voting
if they have a conflict of interest;
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new text begin (ii) using a methodologist to work with writing groups to provide objectivity in data
analysis and ranking of evidence through the preparation of evidence tables and facilitating
consensus; and
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new text begin (iii) offering opportunities for public review and comments;
new text end

new text begin (3) are based on high quality studies, research, and medical practice;
new text end

new text begin (4) are created by an explicit and transparent process that:
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new text begin (i) minimizes biases and conflicts of interest;
new text end

new text begin (ii) explains the relationship between treatment options and outcomes;
new text end

new text begin (iii) rates the quality of the evidence supporting recommendations; and
new text end

new text begin (iv) considers relevant patient subgroups and preferences; and
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new text begin (5) are continually updated through a review of new evidence, research, and newly
developed treatments.
new text end

new text begin (b) In the absence of clinical guidelines that meet the requirements of paragraph (a),
findings in peer-reviewed publications may be substituted. When establishing a step therapy
protocol, the plan sponsor shall also take into account the needs of atypical patient
populations and diagnoses when establishing clinical review criteria.
new text end

new text begin (c) This subdivision shall not be construed to require a plan sponsor to establish a new
entity to develop clinical review criteria to be used for step therapy protocols.
new text end

new text begin Subd. 3. new text end

new text begin Step therapy override. new text end

new text begin (a) When coverage of a prescription drug for the
treatment of any medical condition is restricted for use by the plan sponsor through the use
of a step therapy protocol, the prescriber may override the step therapy protocol. A step
therapy override may be appealed by a plan sponsor using its own appeals procedure.
new text end

new text begin (b) When determining whether to grant an appeal and sustain or revoke the step therapy
override the plan sponsor must take into consideration whether:
new text end

new text begin (1) the required prescription drug is contraindicated or will likely cause an adverse
patient reaction or physical or mental harm to the patient;
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new text begin (2) the required prescription drug is expected to be ineffective based on the known
clinical characteristics of the patient and the known characteristics of the prescription drug
regimen;
new text end

new text begin (3) the patient has tried the required prescription drug while under their current or
previous health coverage, or another prescription drug in the same pharmacologic class or
with the same mechanism of action, and the prescription drug was discontinued due to lack
of efficacy or effectiveness, diminished effect, or an adverse event;
new text end

new text begin (4) the required prescription drug is not in the best interest of the patient, based on
medical necessity; and
new text end

new text begin (5) the patient was stable while on a prescription drug prescribed by their health care
provider for the medical condition under consideration while covered under their current
or previous health coverage.
new text end

new text begin (c) When an appeal is resolved and it is determined that a step therapy override is
sustained, the plan sponsor shall authorize coverage for the prescription drug.
new text end

new text begin (d) A prescriber may file a complaint regarding the revocation of a step therapy override
using the complaint procedure in sections 62Q.68 to 62Q.72.
new text end

new text begin (e) This subdivision shall not be construed to prevent:
new text end

new text begin (1) the plan sponsor from requiring a patient to try an AB-rated generic equivalent prior
to providing coverage for the equivalent branded prescription drug; and
new text end

new text begin (2) a health care provider from prescribing a prescription drug that is determined to be
medically appropriate.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective January 1, 2018.
new text end