1.1 	A bill for an act
1.2 	relating to health; prohibiting health plan companies and the commissioner of 
1.3 	human services from requiring enrollees to follow step therapy protocols for certain 
1.4 	metastatic cancers;amending Minnesota Statutes 2018, section 256B.0625, 
1.5 	subdivision 13f; proposing coding for new law in Minnesota Statutes, chapter 62Q.
1.6 	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

1.7 	Section 1. [62Q.1841] PROHIBITION ON USE OF STEP THERAPY FOR 
1.8 	METASTATIC CANCER.
1.9 		Subdivision 1.Definitions. (a) For purposes of this section, the following definitions 
1.10 	apply.
1.11 	(b) "Health plan" has the meaning given in section 62Q.01, subdivision 3. Health plan 
1.12 	includes health coverage provided by a county-based purchasing plan participating in a 
1.13 	public program under chapter 256B or 256L or an integrated health partnership under section 
1.14 	256B.0755.
1.15 	(c) "Stage four advanced metastatic cancer" means cancer that has spread from the 
1.16 	primary or original site of the cancer to nearby tissues, lymph nodes, or other parts of the 
1.17 	body.
1.18 	(d) "Step therapy protocol" has the meaning given in section 62Q.184, subdivision 1.
1.19 		Subd. 2.Prohibition on use of step therapy protocols. A health plan that provides 
1.20 	coverage for the treatment of stage four advanced metastatic cancer or associated conditions 
1.21 	must not limit or exclude coverage for a drug approved by the United States Food and Drug 
1.22 	Administration that is on the health plan's prescription drug formulary by mandating that 
2.1 	an enrollee with stage four advanced metastatic cancer or associated conditions follow a 
2.2 	step therapy protocol if the use of the approved drug is consistent with:
2.3 	(1) a United States Food and Drug Administration-approved indication; and
2.4 	(2) a clinical practice guideline published by the National Comprehensive Care Network.

2.5 	EFFECTIVE DATE. This section is effective January 1, 2020, and applies to health 
2.6 	plans offered, issued, or renewed on or after that date.

2.7 	Sec. 2. Minnesota Statutes 2018, section 256B.0625, subdivision 13f, is amended to read:
2.8 		Subd. 13f.Prior authorization. (a) The Formulary Committee shall review and 
2.9 	recommend drugs which require prior authorization. The Formulary Committee shall 
2.10 	establish general criteria to be used for the prior authorization of brand-name drugs for 
2.11 	which generically equivalent drugs are available, but the committee is not required to review 
2.12 	each brand-name drug for which a generically equivalent drug is available.
2.13 	(b) Prior authorization may be required by the commissioner before certain formulary 
2.14 	drugs are eligible for payment. The Formulary Committee may recommend drugs for prior 
2.15 	authorization directly to the commissioner. The commissioner may also request that the 
2.16 	Formulary Committee review a drug for prior authorization. Before the commissioner may 
2.17 	require prior authorization for a drug:
2.18 	(1) the commissioner must provide information to the Formulary Committee on the 
2.19 	impact that placing the drug on prior authorization may have on the quality of patient care 
2.20 	and on program costs, information regarding whether the drug is subject to clinical abuse 
2.21 	or misuse, and relevant data from the state Medicaid program if such data is available;
2.22 	(2) the Formulary Committee must review the drug, taking into account medical and 
2.23 	clinical data and the information provided by the commissioner; and
2.24 	(3) the Formulary Committee must hold a public forum and receive public comment for 
2.25 	an additional 15 days.
2.26 	The commissioner must provide a 15-day notice period before implementing the prior 
2.27 	authorization.
2.28 	(c) Except as provided in subdivision 13j, prior authorization shall not be required or 
2.29 	utilized for any atypical antipsychotic drug prescribed for the treatment of mental illness 
2.30 	if:
2.31 	(1) there is no generically equivalent drug available; and
3.1 	(2) the drug was initially prescribed for the recipient prior to July 1, 2003; or
3.2 	(3) the drug is part of the recipient's current course of treatment.
3.3 	This paragraph applies to any multistate preferred drug list or supplemental drug rebate 
3.4 	program established or administered by the commissioner. Prior authorization shall 
3.5 	automatically be granted for 60 days for brand name drugs prescribed for treatment of mental 
3.6 	illness within 60 days of when a generically equivalent drug becomes available, provided 
3.7 	that the brand name drug was part of the recipient's course of treatment at the time the 
3.8 	generically equivalent drug became available.
3.9 	(d) Prior authorization shall not be required or utilized for any antihemophilic factor 
3.10 	drug prescribed for the treatment of hemophilia and blood disorders where there is no 
3.11 	generically equivalent drug available if the prior authorization is used in conjunction with 
3.12 	any supplemental drug rebate program or multistate preferred drug list established or 
3.13 	administered by the commissioner.
3.14 	(e) The commissioner may require prior authorization for brand name drugs whenever 
3.15 	a generically equivalent product is available, even if the prescriber specifically indicates 
3.16 	"dispense as written-brand necessary" on the prescription as required by section 151.21, 
3.17 	subdivision 2.
3.18 	(f) Notwithstanding this subdivision, the commissioner may automatically require prior 
3.19 	authorization, for a period not to exceed 180 days, for any drug that is approved by the 
3.20 	United States Food and Drug Administration on or after July 1, 2005. The 180-day period 
3.21 	begins no later than the first day that a drug is available for shipment to pharmacies within 
3.22 	the state. The Formulary Committee shall recommend to the commissioner general criteria 
3.23 	to be used for the prior authorization of the drugs, but the committee is not required to 
3.24 	review each individual drug. In order to continue prior authorizations for a drug after the 
3.25 	180-day period has expired, the commissioner must follow the provisions of this subdivision.
3.26 	(g) Any step therapy protocol requirements established by the commissioner must comply 
3.27 	with section 62Q.1841.

3.28 	EFFECTIVE DATE. This section is effective January 1, 2020.