HOUSE BILL NO. 5339
November 14, 2023, Introduced by Reps. McFall, Arbit, Price, Morgan, Rheingans, Hope, Hood,
Edwards, Weiss, Brixie, Tsernoglou, Aiyash, Hoskins, Brenda Carter and Wegela and referred
to the Committee on Insurance and Financial Services.
A bill to amend 1956 PA 218, entitled
"The insurance code of 1956,"
by amending section 3406t (MCL 500.3406t), as added by 2016 PA 38.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
1 Sec. 3406t. (1) An insurer that delivers, issues for delivery,
2 or renews in this state an expense-incurred hospital, medical, or
3 surgical group or individual a health insurance policy or
4 certificate that provides prescription drug coverage , or a health
5 maintenance organization that offers a group or individual contract
6 that provides prescription drug coverage, shall provide a program
7 for synchronizing multiple maintenance prescription drugs for an
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1 insured or enrollee if both of the following are met:
2 (a) The insured or enrollee, the insured's or enrollee's
3 physician, and a pharmacist agree that synchronizing the insured's
4 or enrollee's multiple maintenance prescription drugs for the
5 treatment of a chronic long-term care condition is in the best
6 interests of the insured or enrollee for the management or
7 treatment of a chronic long-term care condition.
8 (b) The insured's or enrollee's multiple maintenance
9 prescription drugs meet all of the following requirements:
10 (i) Are covered by the health insurance policy , certificate,
11 or contract described in this section.
12 (ii) Are used for the management and treatment of a chronic
13 long-term care condition and have authorized refills that remain
14 available to the insured or enrollee.
15 (iii) Except as otherwise provided in this subparagraph, are not
16 controlled substances included in schedules 2 to 5 under sections
17 7214, 7216, 7218, and 7220 of the public health code, 1978 PA 368,
18 MCL 333.7214, 333.7216, 333.7218, and 333.7220. This subparagraph
19 does not apply to anti-epileptic prescription drugs.
20 (iv) Meet all prior authorization requirements specific to the
21 maintenance prescription drugs at the time of the request to
22 synchronize the insured's or enrollee's multiple maintenance
23 prescription drugs.
24 (v) Are of a formulation that can be effectively split over
25 required short fill periods to achieve synchronization.
26 (vi) Do not have quantity limits or dose optimization criteria
27 or requirements that will be violated when synchronizing the
28 insured's or enrollee's multiple maintenance prescription drugs.
29 (2) An insurer or health maintenance organization described in
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1 subsection (1) shall apply a prorated daily cost-sharing rate for
2 maintenance prescription drugs that are dispensed by an in-network
3 pharmacy for the purpose of synchronizing the insured's or
4 enrollee's multiple maintenance prescription drugs.
5 (3) An insurer or health maintenance organization described in
6 subsection (1) shall not reimburse or pay any dispensing fee that
7 is prorated. The insurer or health maintenance organization shall
8 only pay or reimburse a dispensing fee that is based on each
9 maintenance prescription drug dispensed.
10 (4) If an insurer described in subsection (1) or a utilization
11 review organization implements a step therapy protocol, an insurer
12 or utilization review organization shall do both of the following:
13 (a) Implement protocol via clinical review criteria that are
14 based on clinical practice guidelines to which all of the following
15 apply:
16 (i) The guidelines recommend that the prescription drugs be
17 taken in the specific sequence required by the step therapy
18 protocol.
19 (ii) Subject to subparagraph (vi), the guidelines are developed
20 and endorsed by a multidisciplinary panel of experts that manages
21 conflicts of interest among the members of the writing and review
22 groups by doing all of the following:
23 (A) Requiring members to disclose any potential conflict of
24 interests with entities, including insurers, health plans, and
25 pharmaceutical manufacturers and recuse themselves from voting if
26 they have a conflict of interest.
27 (B) Using a methodologist to work with writing groups to
28 provide objectivity in data analysis and ranking evidence through
29 the preparation of evidence tables and facilitating consensus.
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1 (C) Offering opportunities for public review and comments.
2 (iii) The guidelines are based on high-quality studies,
3 research, and medical practice.
4 (iv) The guidelines are created by an explicit and transparent
5 process that does all of the following:
6 (A) Minimizes biases and conflicts of interest.
7 (B) Explains the relationship between treatment options and
8 outcomes.
9 (C) Rates the quality of the evidence supporting
10 recommendations.
11 (D) Considers relevant patient subgroups and preferences.
12 (v) The guidelines are continually updated through a review of
13 new evidence, research, and newly developed treatments.
14 (vi) If there are no clinical guidelines that meet the
15 requirements in subparagraph (ii), peer-reviewed publications may be
16 substituted.
17 (b) Take into account the needs of an atypical patient
18 population and diagnosis when establishing clinical review
19 criteria.
20 (5) An insurer described in subsection (1) or utilization
21 review organization shall do both of the following:
22 (a) On written request, provide in writing all specific
23 clinical review criteria relating to the particular condition or
24 disease including clinical review criteria relating to a step
25 therapy protocol override determination.
26 (b) Make available the clinical review criteria and other
27 clinical information on its internet site and to a health care
28 professional on behalf of an insured on written request.
29 (6) Subsection (4) does not require an insurer to set up a new
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1 entity to develop clinical review criteria for step therapy
2 protocols.
3 (7) If coverage of a prescription drug for the treatment of a
4 medical condition is restricted for use by an insurer described in
5 subsection (1) or utilization review organization through the use
6 of a step therapy protocol, the insurer or utilization review
7 organization shall provide the prescribing health care provider
8 access to a clear, easily accessible, and convenient process to
9 request a step therapy exception on behalf of a covered individual.
10 An insurer or utilization review organization may use its existing
11 medical exceptions process to satisfy this requirement. The process
12 must be made easily accessible on the insurer's or utilization
13 review organization's website. An insurer or utilization review
14 organization must disclose all rules and criteria related to the
15 step therapy protocol on request to all prescribing practitioners,
16 including the specific information and documentation that must be
17 submitted by a prescribing practitioner or patient to be considered
18 a complete exception request.
19 (8) A step therapy exception must be expeditiously granted if
20 any of the following conditions are met:
21 (a) The required prescription drug is contraindicated or will
22 likely cause an adverse reaction by or physical or mental harm to
23 the patient.
24 (b) The required prescription drug is expected to be
25 ineffective based on the known clinical characteristics of the
26 patient and the known characteristics of the prescription drug
27 regimen.
28 (c) The patient has tried the required prescription drug while
29 under the patient's current or a previous health insurance or
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1 health benefit plan, or another prescription drug in the same
2 pharmacologic class or with the same mechanism of action, and the
3 prescription drug was discontinued because of lack of efficacy or
4 effectiveness, diminished effect, or an adverse event.
5 (d) The required prescription drug is not in the best interest
6 of the patient, based on medical necessity.
7 (e) The patient is stable on a prescription drug selected by
8 the patient's health care provider for the medical condition under
9 consideration while on a current or previous health benefit plan.
10 (9) On the granting of a step therapy exception under
11 subsection (8), the insurer described in subsection (1) or
12 utilization review organization shall authorize coverage for the
13 prescription drug prescribed by the patient's treating health care
14 provider.
15 (10) The insurer or utilization review organization shall
16 grant or deny a step therapy exception request or an appeal within
17 72 hours after receipt. If exigent circumstances exist, an insurer
18 or utilization review organization must grant or deny a step
19 therapy exception request or an appeal within 24 hours after
20 receipt. If a request for a step therapy override exception is
21 incomplete or additional clinically relevant information is
22 required, the insurer or utilization review organization shall
23 notify the prescribing practitioner within 72 hours after
24 submission, or 24 hours in exigent circumstances, what additional
25 or clinically relevant information is required to approve or deny
26 the step therapy exception request or appeal in accordance with the
27 criteria disclosed in subsection (4). Once the requested
28 information is submitted, the applicable time period to grant or
29 deny a step therapy exception request or appeal applies. If a
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1 determination or request for incomplete or clinically relevant
2 information by an insurer or utilization review organization is not
3 received by the prescribing practitioner within the time allotted,
4 the exception or appeal is considered granted. In the event of a
5 denial, the insurer or utilization review organization must inform
6 the patient of a potential appeal process.
7 (11) This section does not prevent any of the following:
8 (a) An insurer described in subsection (1) or utilization
9 review organization from requiring a patient to try an AB-rated
10 generic equivalent or interchangeable biological product, unless
11 the requirement meets any of the conditions under subsection (8) in
12 accordance with a step therapy exception request submitted under
13 subsection (7), before providing coverage for the equivalent
14 branded prescription drug.
15 (b) An insurer or utilization review organization from
16 requiring a pharmacist to effect substitutions of prescription
17 drugs consistently with section 17755 of the public health code,
18 1978 PA 368, MCL 333.17755.
19 (c) A health care provider from prescribing a prescription
20 drug that is determined to be medically appropriate.
21 (12) Annually, an insurer described in subsection (1) or
22 utilization review organization shall report to the director, in a
23 format prescribed by the director, all of the following
24 information:
25 (a) The number of step therapy exception requests received by
26 exception as provided under subsection (8).
27 (b) The type of health care providers or the medical
28 specialties of the health care providers submitting step therapy
29 exception requests.
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1 (c) The number of step therapy exception requests by
2 exception, as provided under subsection (8), that were denied and
3 the reasons for the denials.
4 (d) The number of step therapy exception requests by
5 exception, as provided under subsection (8), that were approved.
6 (e) The number of step therapy exception requests by
7 exception, as provided under subsection (8), that were initially
8 denied and then appealed.
9 (f) The number of step therapy exception requests by
10 exception, as provided under subsection (8), that were initially
11 denied and then subsequently reversed by internal appeals or
12 external reviews.
13 (g) The medical conditions for which patients are granted
14 exceptions because of the likelihood that switching from the
15 prescription drug will likely cause an adverse reaction by or
16 physical or mental harm to the insured.
17 (13) As used in this section:
18 (a) "Clinical practice guidelines" means a systematically
19 developed statement to assist decision making by health care
20 providers and patient decisions about appropriate health care for
21 specific clinical circumstances and conditions.
22 (b) "Clinical review criteria" means the written screening
23 procedures, decision abstracts, clinical protocols, and practice
24 guidelines used by an insurer or utilization review organization to
25 determine the medical necessity and appropriateness of health care
26 services.
27 (c) "Medical necessity" means that health services or supplies
28 are, under the applicable standard of care, any of the following:
29 (i) Appropriate to improve or preserve health, life, or
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1 function.
2 (ii) Appropriate to slow the deterioration of health, life, or
3 function.
4 (iii) Appropriate for the early screening, prevention,
5 evaluation, diagnosis, or treatment of a disease, condition,
6 illness, or injury.
7 (d) "Step therapy protocol" means a protocol, policy, or
8 program that establishes the specific sequence in which
9 prescription drugs for a specified medical condition and medically
10 appropriate for a particular patient are covered by an insurer or
11 health plan.
12 (e) "Step therapy exception" means an overriding step therapy
13 protocol in favor of immediate coverage of the health care
14 provider's selected prescription drug.
15 (f) "Utilization review organization" means an entity that
16 conducts utilization review, other than an insurer or health plan
17 performing utilization review for its own health benefit plans.
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Statutes affected:
House Introduced Bill: 500.3406