1.1 	A bill for an act
1.2 	relating to health insurance; regulating the use of step therapy for the coverage of 
1.3 	prescription drugs;proposing coding for new law in Minnesota Statutes, chapter 
1.4 	62Q.
1.5 	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

1.6 	Section 1. [62Q.183] STEP THERAPY OVERRIDE.
1.7 		Subdivision 1.Definitions. (a) For purposes of this section, the terms in paragraphs (b) 
1.8 	through (f) have the meanings given.
1.9 	(b) "Clinical practice guideline" means a systematically developed statement to assist 
1.10 	health care providers and patients in making decisions about appropriate health care for 
1.11 	specific clinical circumstances and conditions.
1.12 	(c) "Clinical review criteria" means the written screening procedures, decision abstracts, 
1.13 	clinical protocols, and clinical practice guidelines used by the plan sponsor to determine 
1.14 	the medical necessity and appropriateness of health care services.
1.15 	(d) "Plan sponsor" means a health plan company or a utilization review organization as 
1.16 	defined in section 62M.02, subdivision 21.
1.17 	(e) "Step therapy protocol" means a protocol or program that establishes the specific 
1.18 	sequence in which prescription drugs for a specified medical condition, including 
1.19 	self-administered and physician-administered drugs, are medically appropriate for a particular 
1.20 	patient and are covered under a health plan.
1.21 	(f) "Step therapy override" means that the step therapy protocol should be overridden 
1.22 	in favor of immediate coverage of the health care provider's selected prescription drug. A 
2.1 	step therapy override is granted upon the prescriber's request, but may be appealed by the 
2.2 	plan sponsor in accordance with subdivision 3.
2.3 		Subd. 2.Criteria for step therapy protocols. (a) Clinical review criteria used by a plan 
2.4 	sponsor to establish a step therapy protocol shall be based on clinical practice guidelines 
2.5 	that:
2.6 	(1) recommend that the prescription drugs be taken in the specific sequence required by 
2.7 	the step therapy protocol;
2.8 	(2) are developed and endorsed by a multidisciplinary panel of experts that manages 
2.9 	conflicts of interest among the members of the writing and review groups by:
2.10 	(i) requiring members to disclose any potential conflict of interest with entities including 
2.11 	health plan companies and pharmaceutical manufacturers and recuse themselves of voting 
2.12 	if they have a conflict of interest;
2.13 	(ii) using a methodologist to work with writing groups to provide objectivity in data 
2.14 	analysis and ranking of evidence through the preparation of evidence tables and facilitating 
2.15 	consensus; and
2.16 	(iii) offering opportunities for public review and comments;
2.17 	(3) are based on high quality studies, research, and medical practice;
2.18 	(4) are created by an explicit and transparent process that:
2.19 	(i) minimizes biases and conflicts of interest;
2.20 	(ii) explains the relationship between treatment options and outcomes;
2.21 	(iii) rates the quality of the evidence supporting recommendations; and
2.22 	(iv) considers relevant patient subgroups and preferences; and
2.23 	(5) are continually updated through a review of new evidence, research, and newly 
2.24 	developed treatments.
2.25 	(b) In the absence of clinical guidelines that meet the requirements of paragraph (a), 
2.26 	findings in peer-reviewed publications may be substituted. When establishing a step therapy 
2.27 	protocol, the plan sponsor shall also take into account the needs of atypical patient 
2.28 	populations and diagnoses when establishing clinical review criteria.
2.29 	(c) This subdivision shall not be construed to require a plan sponsor to establish a new 
2.30 	entity to develop clinical review criteria to be used for step therapy protocols.
3.1 		Subd. 3.Step therapy override. (a) When coverage of a prescription drug for the 
3.2 	treatment of any medical condition is restricted for use by the plan sponsor through the use 
3.3 	of a step therapy protocol, the prescriber may override the step therapy protocol. A step 
3.4 	therapy override may be appealed by a plan sponsor using its own appeals procedure.
3.5 	(b) When determining whether to grant an appeal and sustain or revoke the step therapy 
3.6 	override the plan sponsor must take into consideration whether:
3.7 	(1) the required prescription drug is contraindicated or will likely cause an adverse 
3.8 	patient reaction or physical or mental harm to the patient;
3.9 	(2) the required prescription drug is expected to be ineffective based on the known 
3.10 	clinical characteristics of the patient and the known characteristics of the prescription drug 
3.11 	regimen;
3.12 	(3) the patient has tried the required prescription drug while under their current or 
3.13 	previous health coverage, or another prescription drug in the same pharmacologic class or 
3.14 	with the same mechanism of action, and the prescription drug was discontinued due to lack 
3.15 	of efficacy or effectiveness, diminished effect, or an adverse event;
3.16 	(4) the required prescription drug is not in the best interest of the patient, based on 
3.17 	medical necessity; and
3.18 	(5) the patient was stable while on a prescription drug prescribed by their health care 
3.19 	provider for the medical condition under consideration while covered under their current 
3.20 	or previous health coverage.
3.21 	(c) When an appeal is resolved and it is determined that a step therapy override is 
3.22 	sustained, the plan sponsor shall authorize coverage for the prescription drug.
3.23 	(d) A prescriber may file a complaint regarding the revocation of a step therapy override 
3.24 	using the complaint procedure in sections 62Q.68 to 62Q.72.
3.25 	(e) This subdivision shall not be construed to prevent:
3.26 	(1) the plan sponsor from requiring a patient to try an AB-rated generic equivalent prior 
3.27 	to providing coverage for the equivalent branded prescription drug; and
3.28 	(2) a health care provider from prescribing a prescription drug that is determined to be 
3.29 	medically appropriate.

3.30 	EFFECTIVE DATE. This section is effective January 1, 2018.