Senate Commerce Committee Statement to Senate, No. 3533 (October 10, 2024)

Summary

Senate Commerce Committee statement to Senate, No. 3533, State of New Jersey, dated October 10, 2024. The committee reports favorably Senate Bill No. 3533, which requires health insurance carriers and utilization review organizations to meet certain guidelines in the administration and review of step therapy protocols. The statement says the bill defines “step therapy protocol” as a protocol, policy, or program that establishes the specific sequence in which prescription drugs for a specified medical condition are covered by a health benefits plan. It says a carrier or utilization review organization is to report to the Commissioner of Banking and Insurance certain information concerning the step therapy exceptions requested, appealed, denied, and granted.

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     SENATE COMMERCE COMMITTEE

                    STATEMENT TO

                  SENATE, No. 3533

 STATE OF NEW JERSEY
                   DATED: OCTOBER 10, 2024

    The Senate Commerce Committee reports favorably Senate Bill
No. 3533.
    This bill requires health insurance carriers and utilization review
organizations to meet certain guidelines in the administration and
review of step therapy protocols. The bill defines “step therapy
protocol” as a protocol, policy, or program that establishes the
specific sequence in which prescription drugs for a specified
medical condition, and medically appropriate for a particular
patient, are covered by a health benefits plan.
   The bill provides that clinical review criteria used to establish a
step therapy protocol are to be based on clinical practice guidelines
that:
   (1) recommend that the prescription drugs be taken in the
specific sequence required by the step therapy protocol;
   (2) are developed and endorsed by a multidisciplinary panel of
experts that manages conflicts of interest among the members of the
writing and review groups by following certain procedures outlined
in the bill;
   (3) are based on high quality studies, research, and medical
practice;
   (4) are created by an explicit and transparent process that
minimizes biases and conflicts of interest, explains the relationship
between treatment options and outcomes, rates the quality of the
evidence supporting recommendations, and considers relevant
patient subgroups and preferences; and
   (5) are continually updated through a review of new evidence,
research, and newly developed treatments.
   In addition, the bill provides guidelines for the review of step
therapy exceptions. Under the bill, “step therapy exception” means
the overriding of a step therapy protocol in favor of immediate
coverage of the health care provider’s selected prescription drug.
   The bill provides that when coverage of a prescription drug for
the treatment of any medical condition is restricted for use by a
carrier or utilization review organization through the use of a step
therapy protocol, the carrier or utilization review organization is to
provide the covered person and prescribing practitioner a clear,
readily accessible, and convenient process to request a step therapy
exception. Under the bill, a carrier or utilization review
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organization may use its existing medical exceptions process to
satisfy this requirement. An explanation of the process is to be
made available on the carrier or utilization review organization’s
website.
   A step therapy exception is to be granted if:
   (1) the required prescription drug is contraindicated or is likely
to cause an adverse reaction or physical or mental harm to the
patient;
   (2) the required prescription drug is expected to be ineffective
based on the known clinical characteristics of the patient and the
known characteristics of the prescription drug regimen;
   (3) the patient has tried the required prescription drug while
under their current or a previous health insurance or health benefits
plan, or another prescription drug in the same pharmacologic class
or with the same mechanism of action and the prescription drug was
discontinued due to lack of efficacy or effectiveness, diminished
effect, or an adverse event;
   (4) the required prescription drug is not in the best interest of
the patient, based on medical necessity; or
   (5) the patient is stable on a prescription drug selected by their
health care provider for the medical condition under consideration
while on a current or previous health insurance or health benefits
plan.
   Under the bill, when a step therapy exception is granted, the
carrier or utilization review organization is to authorize coverage
for the prescription drug prescribed by the patient’s treating health
care provider.
   The bill provides that any step therapy exception is to be eligible
for appeal by a covered person. The carrier or utilization review
organization is to grant or deny a step therapy exception request or
an appeal of a step therapy exception request within 72 hours of
receipt of the request or appeal.           In cases where exigent
circumstances exist, the carrier or utilization review organization is
to respond within 24 hours of receipt of the request or appeal. If a
response by a carrier or utilization review organization is not
received within the time allotted, the exception or appeal is to be
deemed granted.
    The bill also provides that a carrier or utilization review
organization is to report to the Commissioner of Banking and
Insurance certain information concerning the number and nature of
step therapy exceptions requested, appealed, denied, and granted.


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