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LRB-1748/1
TJD:ahe&kjf
2019 - 2020 LEGISLATURE
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.
SB26,1,3 1An Act to create 632.866 of the statutes; relating to: step therapy protocols for
2prescription drug coverage and requiring the exercise of rule-making
3authority.
Analysis by the Legislative Reference Bureau
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.
The people of the state of Wisconsin, represented in senate and assembly, do
enact as follows:
SB26,1 1Section 1. 632.866 of the statutes is created to read:
SB26,2,2 2632.866 Step therapy protocols. (1) Definitions. In this section:
SB26,2,53 (a) “Clinical practice guideline” means a systematically developed statement
4to assist decision making by health care providers and patients about appropriate
5health care for specific clinical circumstances and conditions.
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.
SB26,2,1210 (c) “Exigent circumstances” means when a patient is suffering from a health
11condition that may seriously jeopardize the patient's life, health, or ability to regain
12maximum function.
SB26,3,3
1(d) “Medically necessary” means, as related to health care services and
2supplies, provided under the applicable standard of care and appropriate to do any
3of the following:
SB26,3,44 1. Improve or preserve health, life, or function.
SB26,3,55 2. Slow the deterioration of health, life, or function.
SB26,3,76 3. Provide for the early screening, prevention, evaluation, diagnosis, or
7treatment of a disease, condition, illness, or injury.
SB26,3,88 (e) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).
SB26,3,129 (f) “Step therapy protocol” means a protocol or program that establishes the
10specific sequence in which prescription drugs for a specified medical condition,
11whether self-administered or physician-administered, that are medically
12appropriate for a particular patient are covered under a policy or plan.
SB26,3,1513 (g) “Utilization review organization” means an entity that conducts utilization
14review, other than an insurer or pharmacy benefit manager performing utilization
15review for its own policy or plan.
SB26,3,19 16(2) Clinical review criteria. (a) When establishing a step therapy protocol,
17an insurer, pharmacy benefit manager, or utilization review organization shall use
18clinical review criteria that are based on clinical practice guidelines that satisfy all
19of the following:
SB26,3,2120 1. The guidelines recommend that the prescription drugs be taken in the
21specific sequence required by the step therapy protocol.
SB26,3,2522 2. The guidelines are developed and endorsed by a multidisciplinary panel of
23experts that manages conflicts of interest among its members in accordance with par.
24(b) or, if such guidelines are unavailable, are developed based on peer-reviewed
25publications.
SB26,4,2
13. The guidelines are based on evidence-based, high quality studies, research,
2and medical practice.
SB26,4,43 4. The guidelines are created in an explicit and transparent process that does
4all of the following:
SB26,4,55 a. Minimizes biases and conflicts of interest.
SB26,4,66 b. Explains the relationship between treatment options and outcomes.
SB26,4,77 c. Rates the quality of evidence supporting recommendations.
SB26,4,88 d. Considers relevant patient subgroups and preferences.
SB26,4,109 5. The guidelines are continually updated through a review of new evidence
10and research and newly developed treatments.
SB26,4,1211 (b) To satisfy par. (a) 2., the multidisciplinary panel of experts shall manage
12conflicts of interest among its members by doing all of the following:
SB26,4,1613 1. Requiring members to disclose any potential conflict of interest to specific
14entities, including insurers, pharmacy benefit managers, and pharmaceutical
15manufacturers, and to recuse themselves from voting if they have a conflict of
16interest.
SB26,4,1817 2. Using a methodology to provide objectivity in data analysis and ranking of
18evidence through the preparation of evidence tables and facilitating consensus.
SB26,4,1919 3. Offering opportunities for public review and comments.
SB26,4,2220 (c) An insurer, pharmacy benefit manager, or utilization review organization
21shall consider the needs of atypical patient populations and diagnoses when
22establishing clinical review criteria for the establishment of a step therapy protocol.
SB26,4,2523 (d) Nothing in this subsection shall be construed to require insurers, pharmacy
24benefit managers, or the state to create a new entity to develop clinical review
25criteria used for step therapy protocols.
SB26,5,10
1(3) Transparency of exceptions process. (a) When coverage of a prescription
2drug for the treatment of any medical condition is restricted for use by an insurer,
3pharmacy benefit manager, or utilization review organization through the use of a
4step therapy protocol, the insurer, pharmacy benefit manager, or utilization review
5organization shall provide access to a clear, readily accessible and convenient process
6to request an exception to the step therapy protocol. An insurer, pharmacy benefit
7manager, or utilization review organization may use any existing medical exceptions
8process to satisfy the requirement under this paragraph. The exception process shall
9be made easily accessible on the Internet site of the insurer, pharmacy benefit
10manager, or utilization review organization.
SB26,5,1311 (b) An insurer, pharmacy benefit manager, or utilization review organization
12shall expeditiously grant an exception to the step therapy protocol if any of the
13following are satisfied:
SB26,5,1614 1. The prescription drug required under the step therapy protocol is
15contraindicated or will likely cause an adverse reaction by or physical or mental
16harm to the patient.
SB26,5,1917 2. The prescription drug required under the step therapy protocol is expected
18to be ineffective based on the known clinical characteristics of the patient and the
19known characteristics of the prescription drug regimen.
SB26,5,2420 3. The patient has tried the prescription drug required under the step therapy
21protocol, or another prescription drug in the same pharmacologic class or with the
22same mechanism of action, under the policy or plan or a previous policy or plan and
23the patient's use of the prescription drug was discontinued due to lack of efficacy or
24effectiveness, diminished effect, or an adverse event.
SB26,6,3
14. Based on an evaluation of medically necessary drugs for the patient's
2condition, the prescription drug required under the step therapy protocol is not in the
3best interest of the patient.
SB26,6,64 5. The patient is stable on a prescription drug selected by his or her health care
5provider for the medical condition under consideration while covered under the
6policy or plan or a previous policy or plan.
SB26,6,107 (c) Upon granting an exception to the step therapy protocol under par. (b), the
8insurer, pharmacy benefit manager, or utilization review organization shall
9authorize coverage for the prescription drug prescribed by the patient's treating
10health care provider.
SB26,6,1211 (d) An insured may appeal any request for an exception to the step therapy
12protocol that is denied.
SB26,6,2113 (e) An insurer, pharmacy benefit manager, or utilization review organization
14shall grant or deny a request for any exception to the step therapy protocol within
1572 hours of receipt of the request or the request to appeal the previous decision. In
16exigent circumstances, an insurer, pharmacy benefit manager, or utilization review
17organization shall grant or deny a request for an exception to the step therapy
18protocol within 24 hours of receipt of the request. If the insurer, pharmacy benefit
19manager, or utilization review organization does not grant or deny a request or an
20appeal under the time specified under this paragraph, the exception is considered
21granted.
SB26,6,2222 (f) Nothing in this subsection shall be construed to prevent any of the following:
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