Louisiana HB 263: DRUGS/PRESCRIPTION: Provides for insurance coverage of step therapy or fail first protocols

Bill Text

ENROLLED
ACT No. 181
2020 Regular Session
HOUSE BILL NO. 263
BY REPRESENTATIVE HUVAL
1 AN ACT
2 To amend and reenact R.S. 22:1053, relative to coverage of step therapy or fail first
3 protocols; to provide for clinical review criteria and use of clinical practice
4 guidelines to be used as minimum standards in developing a step therapy or fail first
5 protocol; to provide for clarification on providers lawfully allowed to prescribe; to
6 provide for an override request process for restricted prescription drugs; to provide
7 for override clinical evidence; to provide for decision-making timelines; to provide
8 for appeal rights; to provide for definitions; to provide for application; to provide for
9 effectiveness; to provide for technical changes; and to provide for related matters.
10 Be it enacted by the Legislature of Louisiana:
11 Section 1. R.S. 22:1053 is hereby amended and reenacted to read as follows:
12 §1053. Requirement for coverage of step therapy or fail first protocols
13 A.(1) Any health coverage plan specified in Subsection H L of this Section
14 which includes prescription benefits as part of its policy or contract, which utilizes
15 step therapy or fail first protocols, and which is issued for delivery, delivered,
16 renewed, or otherwise contracted for in this state on or after January 1, 2011, shall
17 comply with the provisions of this Section.
18 (2) The provisions of this Section shall not be construed to prohibit the
19 substitution of an AB-rated generic equivalent or interchangeable biological product
20 as designated by the federal Food and Drug Administration.
21 B.(1) Any step therapy or fail first protocol established by a health coverage
22 plan shall consider clinical review criteria and clinical practice guidelines that are
Page 1 of 7
CODING: Words in struck through type are deletions from existing law; words underscored
are additions.

HB NO. 263 ENROLLED
1 developed and endorsed by a multidisciplinary panel of experts who manage
2 conflicts of interest among the members of writing and review groups by doing all
3 of the following:
4 (a) Requiring members to disclose any potential conflicts of interest with
5 health coverage plans or pharmaceutical manufacturers and to recuse themselves
6 from voting if they have a conflict of interest.
7 (b) Using a methodologist to work with writing groups to provide objectivity
8 in data analysis and ranking of evidence through the preparation of evidence tables
9 and facilitating consensus.
10 (c) Offering opportunities for public review and comments.
11 (d) Creating an explicit and transparent decisionmaking process.
12 (e) Basing decisions on high quality studies, research, peer-reviewed
13 publications, and medical practice.
14 (f) Minimizing biases and conflicts of interest.
15 (g) Explaining the relationship between treatment options and outcomes.
16 (h) Rating the quality of the evidence supporting recommendations.
17 (i) Considering relevant patient subgroups and preferences.
18 (j) Considering the needs of atypical patient populations and diagnoses when
19 establishing clinical review criteria.
20 (k) Recommending that the prescription drugs be taken in the specific
21 sequence required by the step therapy protocol.
22 (l)(i) Continuously reviewing new evidence, research, and newly developed
23 treatments to update the clinical review criteria and clinical practice guidelines.
24 (ii) If clinical practice guidelines are not reasonably available, any step
25 therapy or fail first protocol established by a health coverage plan shall consider
26 peer-reviewed publications or expert guidance from independent experts, which may
27 include practioners with expertise applicable to the relevant health condition.
28 (2) This Subsection shall not be construed to require health coverage plans
29 to establish a new entity to develop clinical review criteria used for step therapy or
30 fail first protocols.
Page 2 of 7
CODING: Words in struck through type are deletions from existing law; words underscored
are additions.

HB NO. 263 ENROLLED
1 C. When medications for the treatment of any medical condition are
2 restricted for use by an insurer by any health coverage plan through a step therapy
3 or fail first protocol, the prescribing physician practitioner shall have access to a
4 clear and convenient process to expeditiously request an override of such the
5 restriction from the insurer. The override process shall be made easily accessible on
6 the health coverage plan's website. An override of such the restriction shall be
7 expeditiously granted by the insurer under health coverage plan if the prescribing
8 practitioner, using sound clinical evidence, can demonstrate any of the following
9 circumstances:
10 (1) The prescribing physician can demonstrate to the health coverage plan,
11 based on sound clinical evidence, that the The preferred treatment required under the
12 step therapy or fail first protocol has been ineffective in the tre