February 8, 2019 - Introduced by Senators Darling, Jacque, Roth, Johnson,
Feyen, Marklein, Nass, Olsen, Ringhand, Wanggaard, Testin, Cowles,
LeMahieu, Carpenter and Wirch, cosponsored by Representatives Nygren,
Oldenburg, Schraa, Kolste, Subeck, Rodriguez, Ballweg, Dittrich,
Petersen, Horlacher, Vorpagel, Mursau, Kuglitsch, Spiros, Edming,
Gundrum, Felzkowski, Kulp, Skowronski, Thiesfeldt, Brooks, Ramthun,
Tittl, Swearingen, Novak, Jagler, VanderMeer, Zimmerman, Krug, Quinn,
Rohrkaste, Duchow, Magnafici, Born, Kurtz, Brandtjen, Plumer,
Summerfield, Loudenbeck, Ott and Knodl. Referred to Committee on Health
and Human Services.

This bill sets specifications on the development and use of and exceptions to
step therapy protocols for prescription drug coverage. A step therapy protocol, as
defined in the bill, is a protocol that establishes the specific sequence in which
prescription drugs for a specified medical condition that are medically appropriate
for a particular patient are covered by a policy or plan. When establishing a step
therapy protocol, an insurer, pharmacy benefit manager, or utilization review
organization must use clinical review criteria based on clinical practice guidelines
that meet certain criteria specified in the bill, including development and
endorsement of the guidelines either by a multidisciplinary panel of experts that
manages conflicts of interest among its members or, in the absence of a
multidisciplinary panel, based on peer reviewed publications. The bill requires the
insurer, pharmacy benefit manager, or utilization review organization to consider
the needs of atypical patient populations and diagnoses when establishing the
clinical review criteria.

If an insurer, pharmacy benefit manager, or utilization review organization
restricts the coverage of a prescription drug through a step therapy protocol, the
insurer, pharmacy benefit manager, or utilization review organization must provide
access to a process to request an exception to the step therapy protocol, though an

existing medical exceptions process may be used to satisfy this requirement. The
insurer, pharmacy benefit manager, or utilization review organization must
expeditiously grant an exception to the step therapy protocol under certain
circumstances specified in the bill, including when the drug is contraindicated for the
patient or will likely cause an adverse reaction for the patient; the drug is expected
to be ineffective; the patient tried the drug previously and discontinued its use due
to adverse event or ineffectiveness; use of the drug is not in the patient's best interest;
or the patient is stable on a different drug under this or a previous policy or plan.
Upon granting an exception to the step therapy protocol, the insurer, pharmacy
benefit manager, or utilization review organization must authorize coverage for the
drug prescribed by the patient's treating health care provider. An insured may
appeal a denied request for an exception to the step therapy protocol. An insurer,
pharmacy benefit manager, or utilization review organization must grant or deny a
request for an exception within 72 hours of receipt, or within 24 hours in exigent
circumstances. If this deadline is not met, the exception is considered granted.

SB26,2,96 (b) “Clinical review criteria” means written screening procedures, decision
7abstracts, clinical protocols, and clinical practice guidelines used by an insurer,
8pharmacy benefit manager, or utilization review organization to determine whether
9health care services are medically necessary and appropriate.