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 grant an
exception to the step therapy protocol if the prescribing provider submits complete,
clinically relevant written documentation supporting the request and any of the
circumstances specified in the bill apply, including when the drug is contraindicated
for the patient or will likely cause a serious adverse event for the patient; the drug
is expected to be ineffective based on certain evidence and the known characteristics
of the patient and the drug regimen; the patient previously tried the drug or a similar
drug and its use by the patient was discontinued under circumstances described in
the bill; 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 to the extent the drug
is covered under the patient's policy or plan. 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 three business days, or by the end of the next business day in exigent
circumstances, of receipt of supporting documentation. 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-SSA1,1
1Section
1. 632.866 of the statutes is created to read:
SB26-SSA1,2,2
2632.866 Step therapy protocols.
(1) Definitions. In this section:
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(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.
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(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.
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(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.
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(d) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).
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1(e) “Step therapy protocol” means a protocol or program that establishes the
2specific sequence in which prescription drugs for a specified medical condition,
3whether self-administered or physician-administered, that are medically
4appropriate for a particular patient are covered under a policy or plan.
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(f) “Utilization review organization” means an entity that conducts utilization
6review, other than an insurer or pharmacy benefit manager performing utilization
7review for its own policy or plan.
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8(2) Clinical review criteria. (a) When establishing a step therapy protocol,
9an insurer, pharmacy benefit manager, or utilization review organization shall use
10clinical review criteria that are based on clinical practice guidelines that are derived
11from peer-review publications, evidence-based research, and widely accepted
12medical practice. If such clinical practice guidelines are unavailable, the insurer,
13pharmacy benefit manager, or utilization review organization shall derive clinical
14review criteria from peer-reviewed publications, evidence-based research, and
15widely accepted medical practice. The insurer, pharmacy benefit manager, or
16utilization review organization shall continually update the clinical review criteria
17based on an update to the clinical practice guidelines or a review of new evidence and
18research and newly developed treatments.
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(b) Any individual involved in establishing a step therapy protocol under this
20subsection shall disclose to the insurer, pharmacy benefit manager, or utilization
21review organization any potential conflict of interest due to a financial or other
22relationship or payment from a pharmaceutical manufacturer and shall recuse
23himself or herself from voting on a decision regarding the step therapy protocol if he
24or she has a conflict of interest.
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1(c) An insurer, pharmacy benefit manager, or utilization review organization
2shall describe on its Internet site the process and criteria used for selecting and
3evaluating clinical practice guidelines used under par. (a) to develop step therapy
4protocols.
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(d) Nothing in this subsection shall be construed to require insurers, pharmacy
6benefit managers, or the state to create a new entity to develop clinical review
7criteria used for step therapy protocols.
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8(3) Transparency of exceptions process. (a) When coverage of a prescription
9drug for the treatment of any medical condition is restricted for use by an insurer,
10pharmacy benefit manager, or utilization review organization through the use of a
11step therapy protocol, the insurer, pharmacy benefit manager, or utilization review
12organization shall provide access to a clear, readily accessible and convenient process
13to request an exception to the step therapy protocol. An insurer, pharmacy benefit
14manager, or utilization review organization may use any existing medical exceptions
15process to satisfy the requirement under this paragraph. The exception process shall
16be made easily accessible on the Internet site of the insurer, pharmacy benefit
17manager, or utilization review organization.
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(b) An insurer, pharmacy benefit manager, or utilization review organization
19shall grant an exception to the step therapy protocol if the prescribing provider
20submits complete, clinically relevant written documentation supporting a step
21therapy exception request and any of the following are satisfied:
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1. The prescription drug required under the step therapy protocol is
23contraindicated or, due to a documented adverse event with a previous use or a
24documented medical condition, including a comorbid condition, is likely to do any of
25the following:
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1a. Cause a serious adverse reaction in the patient.
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b. Decrease the ability to achieve or maintain reasonable functional ability in
3performing daily activities.
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c. Cause physical or psychiatric harm to the patient.
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2. The prescription drug required under the step therapy protocol is expected
6to be ineffective based on all of the following:
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a. Sound clinical evidence or medical and scientific evidence.
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b. The known clinical characteristics of the patient.
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c. The known characteristics of the prescription drug regimen as described in
10peer-reviewed literature or the manufacturer's prescribing information for the
11prescription drug.
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3. The patient has tried the prescription drug required under the step therapy
13protocol, or another prescription drug in the same pharmacologic class or with the
14same mechanism of action, under the policy or plan or a previous policy or plan, the
15patient was adherent to the prescription drug regimen for a time that allows for a
16positive treatment outcome, and the patient's use of the prescription drug was
17discontinued by the patient's provider due to lack of efficacy or effectiveness,
18diminished effect, or adverse event. This subdivision does not prohibit an insurer,
19pharmacy benefit manager, or utilization review organization from requiring a
20patient to try another drug in the same pharmacologic class or with the same
21mechanism of action if that therapy sequence is supported by clinical review criteria
22under sub. (2) (a).
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4. The patient is stable on a prescription drug selected by his or her health care
24provider for the medical condition under consideration while covered under the
25policy or plan or a previous policy or plan.
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1(c) Nothing in this subsection shall be construed to allow the use of a
2pharmaceutical sample to satisfy a criterion for an exception to a step therapy
3protocol.
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(d) Upon granting an exception to the step therapy protocol under par. (b), the
5insurer, pharmacy benefit manager, or utilization review organization shall
6authorize coverage for the prescription drug prescribed by the patient's treating
7health care provider to the extent the prescribed drug is covered under the patient's
8policy or plan.
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(e) An insured may appeal any request for an exception to the step therapy
10protocol that is denied.
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(f) An insurer, pharmacy benefit manager, or utilization review organization
12shall grant or deny a request for any exception to the step therapy protocol within
133 business days of receipt of the complete, clinically relevant written documentation
14required under par. (b) to support a step therapy exception request under par. (b) or
15the receipt of a request to appeal a previous decision that includes the complete,
16clinically relevant written documentation supporting a step therapy exception
17request. In exigent circumstances, an insurer, pharmacy benefit manager, or
18utilization review organization shall grant or deny a request for an exception to the
19step therapy protocol by the end of the next business day after receipt of the complete,
20clinically relevant written documentation supporting a step therapy exception
21request under par. (b). If the insurer, pharmacy benefit manager, or utilization
22review organization does not grant or deny a request or an appeal under the time
23specified under this paragraph, the exception is considered granted.
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(g) Nothing in this subsection shall be construed to prevent any of the following:
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11. An insurer, pharmacy benefit manager, or utilization review organization
2from requiring a patient to try an A-rated generic equivalent prescription drug, as
3designated by the federal food and drug administration, or a biosimilar, as defined
4under
42 USC 262 (i) (2), before providing coverage for the equivalent brand name
5prescription drug.
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2. A health care provider from prescribing a prescription drug that is
7determined to be medically appropriate.
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8(4) Rules. The commissioner shall promulgate any rules necessary to
9implement or enforce this section.
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(1) For policies and plans containing provisions inconsistent with this act, the
12act first applies to policy or plan years beginning on January 1 of the year following
13the year in which this subsection takes effect.
SB26-SSA1,7,1615
(1)
This act takes effect on the first day of the 4th month beginning after
16publication.