Bill Text: IA HF233 | 2017-2018 | 87th General Assembly | Enrolled
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. (Formerly HSB 26.) Effective 7-1-17.
Spectrum: Committee Bill
Status: (Passed) 2017-05-10 - Signed by Governor. H.J. 1147. [HF233 Detail]
Download: Iowa-2017-HF233-Enrolled.html
House File 233 - Enrolled
HOUSE FILE
BY COMMITTEE ON HUMAN
RESOURCES
(SUCCESSOR TO HSB 26)
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A BILL FOR
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House File 233
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:
Section 1. 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 an entity subject to the
insurance laws and regulations of this state, or subject
to the jurisdiction of the commissioner, including an
insurance company offering sickness and accident plans, a
health maintenance organization, a nonprofit health service
corporation, a plan established pursuant to chapter 509A
for public employees, or any other entity providing a plan
of health insurance, health care benefits, or health care
services. "Health carrier" includes an organized delivery
system. "Health carrier" does not include a managed care
organization as defined in 441 IAC 73.1 when the managed care
organization is acting pursuant to a contract with the Iowa
department of human services to provide services to Medicaid
recipients.
i. "Pharmaceutical sample" means a unit of a prescription
drug that is not intended to be sold and is intended to promote
the sale of the drug.
j. "Step therapy override exception" means a step therapy
protocol should be overridden in favor of coverage of the
prescription drug selected by a health care professional
within the applicable time frames and in compliance with the
requirements specified in section 505.26, subsection 7, for a
request for prior authorization of prescription drug benefits.
This determination is based on a review of the covered person's
or health care professional's request for an override, along
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 health
carrier, health benefit plan, or utilization review
organization shall consider available recognized evidence=based
and peer=reviewed clinical practice guidelines when
establishing a step therapy protocol. Upon written request
of a covered person, a health carrier, health benefit plan,
or utilization review organization shall provide any clinical
review criteria applicable to a specific prescription drug
covered by the health carrier, health benefit plan, or
utilization review organization.
3. Step therapy override 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
health carrier, health benefit plan, or utilization review
organization.
b. A step therapy override exception shall be approved 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 pursuant to the drug manufacturer's
prescribing information for the drug or, due to a documented
adverse event with a previous use or a documented medical
condition, including a comorbid condition, is likely to do any
of the following:
(a) Cause an adverse reaction to a covered person.
(b) Decrease the ability of a covered person to achieve
or maintain reasonable functional ability in performing daily
activities.
(c) Cause physical or mental harm to a 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, such as the
covered person's adherence to or compliance with the covered
person's individual plan of care, and any of the following:
(a) The known characteristics of the prescription drug
regimen as described in peer=reviewed literature or in the
manufacturer's prescribing information for the drug.
(b) The health care professional's medical judgment based
on clinical practice guidelines or peer=reviewed journals.
(c) The covered person's documented experience with the
prescription drug regimen.
(3) The covered person has had a trial of a therapeutically
equivalent dose of the prescription drug under the step
therapy protocol while under the covered person's current or
previous health benefit plan for a period of time to allow for
a positive treatment outcome, and such prescription drug was
discontinued by the covered person's health care professional
due to lack of effectiveness.
(4) The covered person is currently receiving a positive
therapeutic outcome on a prescription drug selected by the
covered person's health care professional for the medical
condition under consideration while under the covered person's
current or previous health benefit plan. This subparagraph
shall not be construed to encourage the use of a pharmaceutical
sample for the sole purpose of meeting the requirements for a
step therapy override exception.
c. Upon approval of a step therapy override exception, the
health carrier, health benefit plan, or utilization review
organization shall authorize coverage for the prescription
drug selected by the covered person's prescribing health care
professional if the prescription drug is a covered prescription
drug under the covered person's health benefit plan.
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 the
applicable time frames and in compliance with the requirements
specified in section 505.26, subsection 7, for a request for
prior authorization of prescription drug benefits.
e. If a request for a step therapy override exception is
denied, 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 the
denial 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 a prescription drug with the same generic name
and demonstrated bioavailability or a biological product that
is an interchangeable biological product pursuant to section
155A.32 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. 2. 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.
LINDA UPMEYER
JACK WHITVER
CARMINE BOAL
TERRY E. BRANSTA
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