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HB216
HOUSE OF REPRESENTATIVES
H.B. NO.
216
THIRTY-THIRD LEGISLATURE, 2025
STATE OF HAWAII
A BILL FOR AN ACT
relating
to prescription drugs
.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:
����
SECTION 1.
�
The legislature finds that health insurance
plans are increasingly making use of step therapy protocols which require
patients to try one or more prescription drug alternatives before insurance coverage
is provided for the particular prescription drug selected by the patient's
health care provider.
�
Step therapy
protocols can serve an important role in controlling health care costs when
they are based on well-developed scientific standards and administered in a
flexible manner that considers the individual needs of patients.
�
However, requiring a patient to follow a step
therapy protocol may have adverse and even dangerous consequences for a patient
who may not realize a benefit from taking a required prescription drug
alterative or suffer harm if the step therapy protocol requires use of a drug
that is inappropriate for the patient.
����
The legislature further finds that without
uniform statewide policies in place for step therapy protocols, residents of
the State may have varying access to appropriate health care treatment depending
on their particular insurance carrier.
�
It
is imperative that step therapy protocols in the State preserve heath care
providers' right to make treatment decisions in the best interest of the
patient.
����
The
legislature finds that it is necessary for the protection of public health and
safety to require health insurers to base step therapy protocols on appropriate
clinical practice guidelines or published peer reviewed data developed by
independent experts with knowledge of the condition or conditions under
consideration.
�
To protect the interest
of patients statewide, step therapy protocols should include provisions to
exempt patients for whom step therapy would be inappropriate and should ensure
that patients have access to a fair, transparent, and independent process for
requesting an exception to a step therapy protocol when the patients' physician
deems it to be appropriate.
����
Accordingly,
t
he purpose of this Act is to require all insurers in the State to adopt
minimum standards for the use of step therapy protocols to ensure the fair,
consistent, and transparent provision of prescription drugs to residents of the
State.
����
SECTION
2.
�
Chapter 431, Hawaii Revised Statutes,
is amended by adding a new section to article 10A to be appropriately
designated and to read as follows:
����
"
�431:10A-
�
Step therapy protocol; requirements; exceptions.
�
(a)
�
Clinical review criteria used to establish a step therapy protocol shall
be based on clinical practice guidelines.
�
Clinical practice guidelines shall:
����
(1)
�
Recommend that the prescription
drugs be taken in the specific sequence required by the step therapy protocol;
����
(2)
�
Be developed and endorsed by a
multidisciplinary panel of experts that manages conflicts of interest among the
members of the writing and review groups by:
���������
(A)
�
Requiring members to disclose any
potential conflict of interests with entities, including insurers, health
plans, and pharmaceutical manufacturers and recuse themselves of voting if they
have a conflict of interest;
���������
(B)
�
Using a methodologist to work with
writing groups to provide objectivity in data analysis and ranking of evidence
through the preparation of evidence tables and facilitating consensus; and
���������
(C)
�
Offering opportunities for public
review and comments;
���������
provided that in the absence of a
panel, peer reviewed publications shall suffice;
����
(3)
�
Be based on high quality studies,
research, and medical practices;
����
(4)
�
Be
established under an explicit and transparent process that:
���������
(A)
�
Minimizes biases and conflicts of
interest;
���������
(B)
�
Explains the relationship between
treatment options and outcomes;
���������
(C)
�
Rates the quality of the evidence
supporting recommendations; and
���������
(D)
�
Considers relevant patient subgroups
and preferences;
����
(5)
�
Be continually updated through a
review of new evidence, research, and newly developed treatments; and
����
(6)
�
Consider the needs of atypical
patient populations and diagnoses;
Nothing
in this subsection shall be construed to require an insurer, utilization review
organization, or health care provider to create any new entity to develop
clinical review criteria used for step therapy protocols.
����
(b)
�
When coverage of a prescription drug for the
treatment of any medical condition is restricted for use by an insurer or
utilization review organization through the use of a step therapy protocol, the
patient and the prescribing practitioner shall have access to request a step
therapy exception through a clear and convenient process which shall be readily
accessible through the insurer or utilization review organization's
website.
�
An insurer or utilization
review organization may use its existing medical exceptions or appeal process
to satisfy this requirement; provided that the process complies with the
requirements of this section.
�
An
insurer or utilization review organization shall upon written request:
����
(1)
�
Provide a
ll written clinical
review criteria relating to a particular condition or disease or a step therapy
exception determination;
����
(2)
�
Display t
he requested clinical
review criteria and other clinical information on its website; and
����
(3)
�
D
istribute
t
he
requested clinical review criteria and other clinical information to a health
care professional on the behalf of a patient.
����
(c)
�
A step therapy exception shall be granted to
a patient whose relevant medical condition is:
����
(1)
�
C
urrently stabilized by a
particular prescription drug prescribed by the patient's health care provider,
regardless of any current or prior insurance coverage, and the patient's health
care provider has prescribed continued treatment with the same prescription
drug; or
����
(2)
�
Not currently stabilized by a
particular prescription drug and if any prescription drug required under the
applicable step therapy protocol:
���������
(A)
�
Is contraindicated or will likely
cause an adverse reaction by or physical or mental harm to the patient;
���������
(B)
�
Is expected to be ineffective based
on the known clinical characteristics of the patient and the known
characteristics of the prescription drug;
���������
(C)
�
Has been previously prescribed to
the patient or is in the same pharmacologic class or has the same mechanism of
action as another prescription drug that has been prescribed to the patient and
was discontinued by the patient's health care provider due to lack of efficacy
or effectiveness, diminished effect, or an adverse event, regardless of any
current or prior insurance coverage of the prescription drug; or
���������
(D)
�
Will not serve the best interest of
the patient, based on medical necessity.
����
(d)
�
An insurer or utilization review organization
shall make a step therapy exception determination within seventy-two hours of
receipt of a request for an exception or filing of an appeal; provided that if
exigent circumstances exist, a determination shall be made within twenty-four
hours; provided further that if no determination has been made within the time
specified, the exception shall be deemed to be granted.
����
If
a request for a step therapy exception is incomplete or additional clinically
relevant information is required, the insurer or utilization review
organization shall notify the prescribing practitioner within seventy-two hours
of submission of a request for an exception, or within twenty-four hours in
exigent circumstances, what additional or clinically relevant information is
required to approve or deny the step therapy exception request or appeal
pursuant to the criteria disclosed in subsection (a).
�
Once the requested information is submitted,
the applicable time period for an insurer or utilization review organization to
make a step therapy exception determination shall apply.
����
Upon
the grant of a step therapy exception, the insurer or utilization review
organization shall authorize coverage for the particular prescription drug
prescribed by the patient's health care provider.
�
Any adverse determination under this
subsection shall be subject to appeal pursuant to the insurer or utilization
review organization's existing appeal procedures.
����
(e)
�
Every insurer or utilization review
organization subject to this section shall certify annually to the insurance
commissioner that the insurer or utilization review organization's step therapy
protocol meets the requirements of this section.
�
Any proposed change in protocol or clinical
review criteria shall be submitted to the insurance commissioner for approval
before it may be implemented by the insurer or utilization review organization.
����
(f)
�
Notwithstanding any law to the contrary, the
insurance division of the department of commerce and consumer affairs shall
adopt rules necessary for the purposes of this section.
����
(g)
�
Each insurer or utilization review
organization shall annually submit a report to the insurance division of the
department of commerce and consumer affairs, on forms prescribed by the
insurance division of the department of commerce and consumer affairs, that
includes the following:
����
(1)
�
The number of step therapy exception
requests received;
����
(2)
�
The type of health care providers or
the medical specialties of the health care providers submitting step therapy
exception requests;
����
(3)
�
The number of step therapy exception
requests that were:
���������
(A)
�
Denied, including the reasons for
the denials;
���������
(B)
�
Approved;
���������
(C)
�
Initially denied and then appealed;
and
���������
(D)
�
Initially denied and then
subsequently reversed by the internal appeals or external reviews; and
����
(4)
�
The medical conditions under which
patients were granted step therapy exceptions due to the likelihood that
switching from the prescription drug will likely cause an adverse reaction by
or physical or mental harm to the insured.
����
(h)
�
This section applies to any state regulated
plan or health insurance coverage offered in connection with a state regulated
plan that provides coverage of a prescription drug pursuant to a policy that
meets the definition of a step therapy protocol, regardless of whether the
policy is described as a step therapy protocol.
����
(i)
�
Nothing in this section shall be construed to
prevent:
����
(1)
�
An insurer or utilization review
organization from requiring a patient to try an AB-rated generic equivalent
drug or interchangeable biological product before providing coverage for a
name-brand prescription drug, unless the requirement meets the qualifications
for a step therapy exception pursuant to subsection (c);
����
(2)
�
An insurer or utilization review
organization from requiring a pharmacist to effect substitutions of
prescription drugs pursuant to section 328-92; or
����
(3)
�
A health care provider from
prescribing any prescription drug that the provider finds to be medically
appropriate for the patient.
����
(j)
�
For the purposes of this section:
����
"AB-rated
generic equivalent drug" means a prescription drug product that is
considered by the federal Food and Drug Administration to be therapeutically
equivalent to a particular name brand prescription drug.
����
"Clinical
practice guidelines" means a systematically developed statement to assist
decision-making by health care providers and patients about appropriate health
care for specific clinical circumstances and conditions.
����
"Clinical
review criteria" means the written screening procedures, decision
abstracts, clinical protocols, and practice guidelines used by an insurer or
utilization review organization to determine the medical necessity and appropriateness
of health care services.
����
"Interchangeable
biological product" has the same meaning as defined in section 328-91.
����
"Medically
appropriate" means health services and supplies that under the applicable
standard of care are appropriate:
����
(1)
�
To improve or preserve health, life,
or function;
����
(2)
�
To slow the deterioration of health,
life, or function; or
����
(3)
�
For the early screening, prevention,
evaluation, diagnosis, or treatment of a disease, condition, illness, or
injury.
����
"Step
therapy exception determination" means a determination as to whether a
step therapy protocol should apply in a particular situation or be overridden
in favor of immediate coverage of a health care provider's selected
prescription drug based on a review of the patient's or prescriber's request
for an exception and supporting rationale and documentation.
����
"Step
therapy protocol" means a protocol or program that requires the use of
specific prescription drugs in a specific sequence as a condition of coverage
under a policy.
����
"Utilization
review organization" means an entity that conducts utilization reviews,
other than an insurer that performs utilization reviews for its own policies.
"
����
SECTION
3.
�
Chapter 432, Hawaii Revised Statutes,
is amended by adding a new section to article 1 to be appropriately designated
and to read as follows:
����
"
�432:1-
�
Step therapy protocol; requirements;
exceptions.
�
(a)
�
Clinical review criteria used to establish a
step therapy protocol shall be based on clinical practice guidelines.
�
Clinical practice guidelines shall:
����
(1)
�
Recommend that the prescription
drugs be taken in the specific sequence required by the step therapy protocol;
����
(2)
�
Be developed and endorsed by a
multidisciplinary panel of experts that manages conflicts of interest among the
members of the writing and review groups by:
���������
(A)
�
Requiring members to disclose any
potential conflict of interests with entities, including insurers, health
plans, and pharmaceutical manufacturers and recuse themselves of voting if they
have a conflict of interest;
���������
(B)
�
Using a methodologist to work with
writing groups to provide objectivity in data analysis and ranking of evidence
through the preparation of evidence tables and facilitating consensus; and
���������
(C)
�
Offering opportunities for public
review and comments;
���������
provided that in the absence of a
panel, peer reviewed publications shall suffice;
����
(3)
�
Be based on high quality studies,
research, and medical practices;
����
(4)
�
Be
established under an explicit and transparent process that:
���������
(A)
�
Minimizes biases and conflicts of
interest;
���������
(B)
�
Explains the relationship between
treatment options and outcomes;
���������
(C)
�
Rates the quality of the evidence
supporting recommendations; and
���������
(D)
�
Considers relevant patient subgroups
and preferences;
����
(5)
�
Be continually updated through a
review of new evidence, research, and newly developed treatments; and
����
(6)
�
Consider the needs of atypical
patient populations and diagnoses;
Nothing
in this subsection shall be construed to require a mutual benefit society,
utilization review organization, or health care provider to create any new
entity to develop clinical review criteria used for step therapy protocols.
����
(b)
�
When coverage of a prescription drug for the
treatment of any medical condition is restricted for use by a mutual benefit
society or utilization review organization through the use of a step therapy
protocol, the patient and the prescribing practitioner shall have access to request
a step therapy exception through a clear and convenient process which shall be readily
accessible through the mutual benefit society or utilization review
organization's website.
�
A mutual benefit
society or utilization review organization may use its existing medical
exceptions or appeal process to satisfy this requirement; provided that the
process complies with the requirements of this section.
�
A mutual benefit society or
utilization review organization shall upon written request:
����
(1)
�
Provide a
ll written clinical
review criteria relating to a particular condition or disease or a step therapy
exception determination;
����
(2)
�
Display t
he requested
clinical review criteria and other clinical information on its website; and
����
(3)
�
D
istribute
t
he
requested clinical review criteria and other clinical information to a health
care professional on the behalf of a patient.
����
(c)
�
A step therapy exception shall be granted to
a patient whose relevant medical condition is:
����
(1)
�
C
urrently stabilized by a
particular prescription drug prescribed by the patient's health care provider,
regardless of any current or prior insurance coverage, and the patient's health
care provider has prescribed continued treatment with the same prescription
drug; or
����
(2)
�
Not currently stabilized by a
particular prescription drug and if any prescription drug required under the
applicable step therapy protocol:
���������
(A)
�
Is contraindicated or will likely
cause an adverse reaction by or physical or mental harm to the patient;
���������
(B)
�
Is expected to be ineffective based
on the known clinical characteristics of the patient and the known
characteristics of the prescription drug;
���������
(C)
�
Has been previously prescribed to
the patient or is in the same pharmacologic class or has the same mechanism of
action as another prescription drug that has been prescribed to the patient and
was discontinued by the patient's health care provider due to lack of efficacy
or effectiveness, diminished effect, or an adverse event, regardless of any
current or prior insurance coverage of the prescription drug; or
���������
(D)
�
Will not serve the best interest of
the patient, based on medical necessity.
����
(d)
�
A mutual benefit society or utilization
review organization shall make a step therapy exception determination within
seventy-two hours of receipt of a request for an exception or filing of an
appeal; provided that if exigent circumstances exist, a determination shall be
made within twenty-four hours; provided further that if no determination has
been made within the time specified, the exception shall be deemed to be
granted.
����
If
a request for a step therapy exception is incomplete or additional clinically
relevant information is required, the mutual benefit society or utilization
review organization shall notify the prescribing practitioner within
seventy-two hours of submission of a request for an exception, or within twenty-four
hours in exigent circumstances, what additional or clinically relevant
information is required to approve or deny the step therapy exception request
or appeal pursuant to the criteria disclosed in subsection (a).
�
Once the requested information is submitted,
the applicable time period for a mutual benefit society or utilization review
organization to make a step therapy exception determination shall apply.
����
Upon
the grant of a step therapy exception, the mutual benefit society or
utilization review organization shall authorize coverage for the particular
prescription drug prescribed by the patient's health care provider.
�
Any adverse determination under this
subsection shall be subject to appeal pursuant to the mutual benefit society or
utilization review organization's existing appeal procedures.
����
(e)
�
Every mutual benefit society or utilization
review organization subject to this section shall certify annually to the
insurance commissioner that the mutual benefit society or utilization review organization's
step therapy protocol meets the requirements of this section.
�
Any proposed change in protocol or clinical
review criteria shall be submitted to the insurance commissioner for approval
before it may be implemented by the mutual benefit society or utilization
review organization.
����
(f)
�
Notwithstanding any law to the contrary, the
insurance division of the department of commerce and consumer affairs shall
adopt rules necessary for the purposes of this section.
����
(g)
�
Each mutual benefit society or utilization
review organization shall annually submit a report to the insurance division of
the department of commerce and consumer affairs, on forms prescribed by the
insurance division of the department of commerce and consumer affairs, that
includes the following:
����
(1)
�
The number of step therapy exception
requests received;
����
(2)
�
The type of health care providers or
the medical specialties of the health care providers submitting step therapy
exception requests;
����
(3)
�
The number of step therapy exception
requests that were:
���������
(A)
�
Denied, including the reasons for
the denials;
���������
(B)
�
Approved;
���������
(C)
�
Initially denied and then appealed;
and
���������
(D)
�
Initially denied and then
subsequently reversed by the internal appeals or external reviews; and
����
(4)
�
The medical conditions under which
patients were granted step therapy exceptions due to the likelihood that
switching from the prescription drug will likely cause an adverse reaction by
or physical or mental harm to the insured.
����
(h)
�
This section applies to any state regulated
plan or health insurance coverage offered in connection with a state regulated
plan that provides coverage of a prescription drug pursuant to a policy that
meets the definition of a step therapy protocol, regardless of whether the
policy is described as a step therapy protocol.
����
(i)
�
Nothing in this section shall be construed to
prevent:
����
(1)
�
A mutual benefit society or
utilization review organization from requiring a patient to try an AB-rated
generic equivalent drug or interchangeable biological product before providing
coverage for a name-brand prescription drug, unless the requirement meets the
qualifications for a step therapy exception pursuant to subsection (c);
����
(2)
�
A mutual benefit society or
utilization review organization from requiring a pharmacist to effect
substitutions of prescription drugs pursuant to section 328-92; or
����
(3)
�
A health care provider from
prescribing any prescription drug that the provider finds to be medically
appropriate for the patient.
����
(j)
�
For the purposes of this section:
����
"AB-rated
generic equivalent drug" means a prescription drug product that is
considered by the federal Food and Drug Administration to be therapeutically
equivalent to a particular name brand prescription drug.
����
"Clinical
practice guidelines" means a systematically developed statement to assist
decision-making by health care providers and patients about appropriate health
care for specific clinical circumstances and conditions.
����
"Clinical
review criteria" means the written screening procedures, decision
abstracts, clinical protocols, and practice guidelines used by a mutual benefit
society or utilization review organization to determine the medical necessity
and appropriateness of health care services.
����
"Interchangeable
biological product" has the same meaning as defined in section 328-91.
����
"Medically
appropriate" means health services and supplies that under the applicable
standard of care are appropriate:
����
(1)
�
To improve or preserve health, life,
or function;
����
(2)
�
To slow the deterioration of health,
life, or function; or
����
(3)
�
For the early screening, prevention,
evaluation, diagnosis, or treatment of a disease, condition, illness, or
injury.
����
"Step
therapy exception determination" means a determination as to whether a
step therapy protocol should apply in a particular situation or be overridden
in favor of immediate coverage of a health care provider's selected
prescription drug based on a review of the patient's or prescriber's request
for an exception and supporting rationale and documentation.
����
"Step
therapy protocol" means a protocol or program that requires the use of
specific prescription drugs in a specific sequence as a condition of coverage
under a policy.
����
"Utilization
review organization" means an entity that conducts utilization reviews,
other than a mutual benefit society that performs utilization reviews for its
own health benefit plans.
"
����
SECTION
4
.
�
Section
432D-23, Hawaii Revised Statutes, is amended to read as follows:
����
"
�432D-23
�
Required provisions and benefits.
�
Notwithstanding any provision of law to the
contrary, each policy, contract, plan, or agreement issued in the State after
January 1, 1995, by health maintenance organizations pursuant to this chapter,
shall include benefits provided in sections 431:10-212, 431:10A-115,
431:10A-115.5, 431:10A-116, 431:10A-116.2, 431:10A-116.5, 431:10A-116.6,
431:10A-119, 431:10A-120, 431:10A-121, 431:10A-122, 431:10A-125, 431:10A-126,
431:10A-132, 431:10A-133,
431:10A-134,
431:10A-140, [
and 431:10A-134,
]
and 431:10A-
and chapter 431M."
����
SECTION
5.
�
This Act does not affect rights and
duties that matured, penalties that were incurred, and proceedings that were
begun before its effective date.
����
SECTION
6.
�
Statutory material to be repealed is bracketed
and stricken.
�
New statutory material is
underscored.
����
SECTION
7.
�
This Act shall take effect upon its
approval, and shall apply to all health insurance and health benefit plans,
contracts, and agreements issued or renewed in this State after December 31,
2025.
INTRODUCED BY:
_____________________________
Report Title:
Health
Insurance; Prescription Drugs; Step Therapy Protocol; Clinical Review Criteria;
Clinical Practice Guidelines; Exceptions
Description:
Establishes
requirements for the clinical review criteria and clinical practical guidelines
used to establish step therapy protocols.
�
Provides a process for a patient to request an exception to using step
therapy protocols.
�
Establishes insurance
coverage requirements relating to the use of step therapy protocols and
standards to appeal an adverse step therapy exception determination.
The summary description
of legislation appearing on this page is for informational purposes only and is
not legislation or evidence of legislative intent.