Bill Text: IA SSB1072 | 2017-2018 | 87th General Assembly | Introduced

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Bill Title: A bill for an act relating to the use of step therapy protocols for prescription drugs by health carriers, health benefit plans, and utilization review organizations, and including applicability provisions.

Spectrum: Committee Bill

Status: (N/A - Dead) 2017-02-21 - Subcommittee recommends passage. [SSB1072 Detail]

Download: Iowa-2017-SSB1072-Introduced.html

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Senate Study Bill 1072 - Introduced
SENATE FILE _____
BY (PROPOSED COMMITTEE ON
HUMAN RESOURCES BILL BY
CHAIRPERSON SEGEBART)
A BILL FOR
An Act relating to the use of step therapy protocols for
prescription drugs by health carriers, health benefit
plans, and utilization review organizations, and including
applicability provisions.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
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Section 1. LEGISLATIVE FINDINGS. The general assembly
finds and declares the following:
1. Health carriers, health benefit plans, and utilization
review organizations are increasingly making use of step
therapy protocols under which covered persons are required to
try one or more prescription drugs before coverage is provided
for another prescription drug selected by the covered person’s
health care professional.
2. Such step therapy protocols, where they are based on
well-developed scientific standards and administered in a
flexible manner that takes into account the individual needs
of covered persons, can play an important part in controlling
health care costs.
3. In some cases, requiring a covered person to follow
a step therapy protocol may have adverse and even dangerous
consequences for the covered person, who may either not realize
a benefit from taking a particular prescription drug or may
suffer harm from taking an inappropriate prescription drug.
4. Without uniform policies in the state for step therapy
protocols, all covered persons may not receive equivalent or
the most appropriate treatment.
5. It is imperative that step therapy protocols in the state
preserve the health care professional’s right to make treatment
decisions that are in the best interest of the covered person.
6. It is a matter of public interest that the general
assembly require health carriers, health benefit plans, and
utilization review organizations to base step therapy protocols
on appropriate clinical practice guidelines or published peer
review data developed by independent experts with knowledge
of the condition or conditions under consideration; that
covered persons be excepted from step therapy protocols when
inappropriate or otherwise not in the best interest of the
covered persons; and that covered persons have access to a
fair, transparent, and independent process for allowing a
covered person or a health care professional to request an
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exception to a step therapy protocol when the covered person’s
health care professional deems appropriate.
Sec. 2. NEW SECTION . 514F.7 Use of step therapy protocols.
1. Definitions. For the purposes of this section:
a. “Authorized representative” means the same as defined in
section 514J.102.
b. “Clinical practice guidelines” means a systematically
developed statement to assist health care professionals and
covered persons in making decisions about appropriate health
care for specific clinical circumstances and conditions.
c. “Clinical review criteria” means the same as defined in
section 514J.102.
d. “Covered person” means the same as defined in section
514J.102.
e. “Health benefit plan” means the same as defined in
section 514J.102.
f. “Health care professional” means the same as defined in
section 514J.102.
g. “Health care services” means the same as defined in
section 514J.102.
h. “Health carrier” means the same as defined in section
514J.102.
i. “Medical necessity” means health care services and
supplies that under the applicable standard of care are
appropriate for any of the following:
(1) To improve or preserve health, life, or function.
(2) To slow the deterioration of health, life, or function.
(3) For the early screening, prevention, evaluation,
diagnosis, or treatment of a disease, condition, illness, or
injury.
j. “Step therapy override exception” means a step therapy
protocol should be overridden in favor of immediate coverage of
the prescription drug selected by a health care professional.
This determination is based on a review of the covered person’s
or health care professional’s request for an override, along
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with supporting rationale and documentation.
k. “Step therapy protocol” means a protocol or program that
establishes a specific sequence in which prescription drugs for
a specified medical condition and medically appropriate for
a particular covered person are covered under a pharmacy or
medical benefit by a health carrier, a health benefit plan, or
a utilization review organization, including self-administered
drugs and drugs administered by a health care professional.
l. “Utilization review” means a program or process by which
an evaluation is made of the necessity, appropriateness, and
efficiency of the use of health care services, procedures, or
facilities given or proposed to be given to an individual.
Such evaluation does not apply to requests by an individual or
provider for a clarification, guarantee, or statement of an
individual’s health insurance coverage or benefits provided
under a health benefit plan, nor to claims adjudication.
Unless it is specifically stated, verification of benefits,
preauthorization, or a prospective or concurrent utilization
review program or process shall not be construed as a guarantee
or statement of insurance coverage or benefits for any
individual under a health benefit plan.
m. “Utilization review organization” means an entity that
performs utilization review, other than a health carrier
performing utilization review for its own health benefit plans.
2. Establishment of step therapy protocols.
a. A health carrier, health benefit plan, or utilization
review organization shall do all of the following when
establishing a step therapy protocol:
(1) Use clinical review criteria based on clinical practice
guidelines that meet all of the following requirements:
(a) Recommend that particular prescription drugs be taken
in the specific sequence required by the step therapy protocol.
(b) Are developed and endorsed by a multidisciplinary panel
of experts that manages conflicts of interest among members
of the panel’s writing and review groups by doing all of the
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following:
(i) Requiring members to disclose any potential conflicts
of interest with entities, including health carriers,
health benefit plans, utilization review organizations, and
pharmaceutical manufacturers, and requiring members to recuse
themselves from voting if there is a conflict of interest.
(ii) Using a methodologist to work with the panel’s writing
groups to provide objectivity in data analysis and ranking of
evidence through the preparation of evidence tables and by
facilitating consensus.
(iii) Offering opportunities for public review and
comments.
(c) Are based on high-quality studies, research, and
medical practice.
(d) Are created through an explicit and transparent process
that does all of the following:
(i) Minimizes biases and conflicts of interest.
(ii) Explains the relationship between treatment options
and outcomes.
(iii) Rates the quality of the evidence supporting the
recommendations.
(iv) Considers relevant patient subgroups and preferences.
(e) Are continually updated through a review of new
evidence, research, and newly developed treatments.
(2) Take into account the needs of atypical covered person
populations and diagnoses when establishing clinical review
criteria.
(3) Notwithstanding subparagraph (1), peer-reviewed
publications may be substituted for the use of clinical
practice guidelines in establishing a step therapy protocol.
b. This subsection shall not be construed to require
health carriers, health benefit plans, utilization review
organizations, or the state to establish a new entity to
develop clinical review criteria for step therapy protocols.
c. A health carrier, health benefit plan, or utilization
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review organization shall, upon written request of an insured
or prospective insured, provide specific written clinical
review criteria relating to a particular condition or disease,
including clinical review criteria relating to a request for a
step therapy override exception and, where appropriate, other
clinical information which the health carrier, health benefit
plan, or utilization review organization might consider in its
utilization review or in making a determination to approve
or deny a request for a step therapy override exception,
including a description of how the information will be used in
the utilization review process or in making a determination
to approve or deny a request for a step therapy override
exception. However, to the extent that such information is
proprietary to the health carrier, health benefit plan, or
utilization review organization, the insured or prospective
insured shall only use the information for the purposes of
assisting the insured or prospective insured in evaluating the
covered services provided by the health carrier, health benefit
plan, or utilization review organization. Such clinical review
criteria and other clinical information shall also be made
available to a health care professional, upon written request
made by the health care professional on behalf of an insured
or prospective insured.
3. Exceptions process transparency.
a. When coverage of a prescription drug for the
treatment of any medical condition is restricted for use
by a health carrier, health benefit plan, or utilization
review organization through the use of a step therapy
protocol, the covered person and the prescribing health
care professional shall have access to a clear, readily
accessible, and convenient process to request a step therapy
override exception. A health carrier, health benefit plan, or
utilization review organization may use its existing medical
exceptions process to satisfy this requirement. The process
used shall be easily accessible on the internet site of the
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health carrier, health benefit plan, or utilization review
organization.
b. A step therapy override exception shall be approved
expeditiously by a health carrier, health benefit plan,
or utilization review organization if any of the following
circumstances apply:
(1) The prescription drug required under the step therapy
protocol is contraindicated or is likely to cause an adverse
reaction or physical or mental harm to the covered person.
(2) The prescription drug required under the step therapy
protocol is expected to be ineffective based on the known
clinical characteristics of the covered person and the known
characteristics of the prescription drug regimen.
(3) The covered person has tried the prescription drug
required under the step therapy protocol while under the
covered person’s current or a previous health benefit plan,
or another prescription drug in the same pharmacologic class
or with the same mechanism of action, and such prescription
drug was discontinued due to lack of efficacy or effectiveness,
diminished effect, or an adverse event.
(4) The prescription drug required under the step therapy
protocol is not in the best interest of the covered person,
based on medical necessity.
(5) The covered person is stable on a prescription drug
selected by the covered person’s health care professional for
the medical condition under consideration while on the current
or a previous health benefit plan.
c. Upon approval of a step therapy override exception, the
health carrier, health benefit plan, or utilization review
organization shall expeditiously authorize coverage for the
prescription drug selected by the covered person’s prescribing
health care professional.
d. A health carrier, health benefit plan, or utilization
review organization shall make a determination to approve or
deny a request for a step therapy override exception within
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seventy-two hours of receipt of the request for an exception or
appeal of a denial of such a request. In cases where exigent
circumstances exist, a health carrier, health benefit plan, or
utilization review organization shall make a determination to
approve or deny the request for an exception or appeal of a
denial of such a request within twenty-four hours of receipt
of the request for an exception or appeal of a denial of such a
request. If a determination to approve or deny the request for
an exception or appeal of a denial of such a request is not made
within the applicable time period, the request for an exception
or appeal of a denial of such a request shall be deemed to be
approved.
e. If a determination is made to deny a request for
a step therapy override exception, the health carrier,
health benefit plan, or utilization review organization
shall provide the covered person or the covered person’s
authorized representative and the covered person’s prescribing
health care professional with the reason for the denial and
information regarding the procedure to appeal the denial. Any
determination to deny a request for a step therapy override
exception may be appealed by a covered person or the covered
person’s authorized representative.
f. A health carrier, health benefit plan, or utilization
review organization shall uphold or reverse a denial of
a request for a step therapy override exception within
seventy-two hours of receipt of an appeal of the denial.
In cases where exigent circumstances exist as provided in
paragraph “d” , a health carrier, health benefit plan, or
utilization review organization shall make a determination to
uphold or reverse a denial of such a request within twenty-four
hours of receipt of an appeal of the denial. If the denial of
a request for a step therapy override exception is not upheld
or reversed on appeal within the applicable time period, the
denial shall be deemed to be reversed and the request for an
override exception shall be deemed to be approved.
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g. If a denial of a request for a step therapy override
exception is upheld on appeal, the health carrier, health
benefit plan, or utilization review organization shall
provide the covered person or the covered person’s authorized
representative and the patient’s prescribing health care
professional with the reason for upholding the denial on appeal
and information regarding the procedure to request external
review of the denial pursuant to chapter 514J. Any denial of a
request for a step therapy override exception that is upheld
on appeal shall be considered a final adverse determination
for purposes of chapter 514J and is eligible for a request for
external review by a covered person or the covered person’s
authorized representative pursuant to chapter 514J.
4. Limitations. This section shall not be construed to do
either of the following:
a. Prevent a health carrier, health benefit plan, or
utilization review organization from requiring a covered person
to try an AB-rated generic equivalent prescription drug prior
to providing coverage for the equivalent branded prescription
drug.
b. Prevent a health care professional from prescribing
a prescription drug that is determined to be medically
appropriate.
Sec. 3. APPLICABILITY. This Act is applicable to a health
benefit plan that is delivered, issued for delivery, continued,
or renewed in this state on or after January 1, 2018.
EXPLANATION
The inclusion of this explanation does not constitute agreement with
the explanation’s substance by the members of the general assembly.
This bill relates to the use of step therapy protocols
for prescription drugs by health carriers, health benefit
plans, and utilization review organizations, and includes
applicability provisions.
The bill includes legislative findings that step therapy
protocols are increasingly being used by health carriers,
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health benefit plans, and utilization review organizations to
control health care costs, that step therapy protocols that
are based on well-developed scientific standards and flexibly
administered can play an important role in controlling health
care costs, but that in some cases use of such protocols can
have adverse or dangerous consequences for the person for whom
the drugs are prescribed. The bill includes findings that
uniform policies for the use of such protocols that preserve a
health care professional’s right to make treatment decisions
and that provide for exceptions to the use of such protocols
are in the public interest.
The bill defines a “step therapy protocol” as a protocol
or program that establishes a specific sequence in which
prescription drugs for a specified medical condition and
medically appropriate for a particular covered person are
covered under a pharmacy or medical benefit by a health
carrier, a health benefit plan, or a utilization review
organization including self-administered drugs and drugs
administered by a health care professional.
The bill requires that a step therapy protocol be
established using clinical review criteria that are based
on specified clinical practice guidelines. A step therapy
protocol should take into account the needs of atypical
populations and diagnoses. The bill does not require a health
carrier, health benefit plan, utilization review organization,
or the state to establish a new entity to develop clinical
review criteria for such protocols.
Upon written request of an insured or prospective insured,
or upon written request of a health care professional on behalf
of such a person, a health carrier, health benefit plan,
or utilization review organization shall provide specific
written clinical review criteria relating to a particular
condition or disease, including criteria relating to a request
for a step therapy override exception which might be used in
utilization review or in making a determination to approve or
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deny a request for a step therapy override exception. If the
information provided is proprietary the insured or prospective
insured shall use it only for purposes of evaluating covered
services.
The bill also provides that when a step therapy protocol
is in use, the person participating in a health benefit plan
or the person’s prescribing health care professional must
have access to a clear, readily accessible, and convenient
process to request a step therapy override exception. A “step
therapy override exception” means a step therapy protocol
should be overridden in favor of immediate coverage of the
prescription drug selected by the prescribing health care
professional, based on a review of the request along with
supporting rationale and documentation. The bill provides that
the request for an exception shall be granted if specified
circumstances are determined to exist and coverage for the drug
selected by the prescribing health care professional shall be
authorized.
A request for a step therapy override exception must be
approved or denied by the health carrier, health benefit plan,
or utilization review organization utilizing the step therapy
protocol within 72 hours of receipt of the request or appeal of
a denial of such a request, or within 24 hours of receipt of the
request or appeal of a denial of such a request where exigent
circumstances exist. The health carrier, health benefit
plan, or utilization review organization can use its existing
medical exceptions procedure to satisfy this requirement. If
a determination to approve or deny the request or appeal of a
denial of such a request is not made within the applicable time
period, the request is deemed to be approved.
If a determination is made to deny the request for a step
therapy override exception, the health carrier, health benefit
plan, or utilization review organization shall provide the
person making the request with the reason for the denial and
information about the procedure to appeal the denial. Any
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denial of such a request is eligible for appeal.
Upon appeal, the health carrier, health benefit plan, or
utilization review organization shall make a determination to
uphold or reverse the denial within 72 hours, or within 24
hours in the case of exigent circumstances, of receiving the
appeal. If the denial is not upheld or reversed on appeal
within the applicable time period, the denial is deemed to
be reversed and the request for an exception is deemed to be
approved.
If a denial of a request for a step therapy override
exception is upheld on appeal, the person making the appeal
shall be provided with the reason for upholding the denial
on appeal and information regarding the procedure to request
external review of the denial pursuant to Code chapter 514J.
A denial of a request for such an exception that is upheld on
appeal shall be considered a final adverse determination for
purposes of Code chapter 514J and is eligible for a request for
external review pursuant to Code chapter 514J.
The bill shall not be construed to prevent a health carrier,
health benefit plan, or utilization review organization from
requiring a person to try an AB-rated generic equivalent
prescription drug prior to providing coverage for the
equivalent branded prescription drug, or to prevent a health
care professional from prescribing a prescription drug that is
determined to be medically appropriate.
The bill is applicable to a health benefit plan that is
delivered, issued for delivery, continued, or renewed in this
state on or after January 1, 2018.
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