Current through Register 2024 Notice Reg. No. 38, September 20, 2024
(a)
Definitions. The following definitions shall apply to this section:
(1) "Request Form" means the Prescription Drug
Prior Authorization or Step Therapy Exception Request Form set forth in subdivision
(k) of this section or an electronic prior authorization system utilizing the
standard form described in subdivision (c).
(2) "Material information" means information that
is:
(A) related to the patient's clinical condition
sufficient to enable an individual with the appropriate training and experience to
determine whether the prescription authorization or step therapy exception request
should be approved or disapproved; or
(B) required by state or federal law for
dispensing restricted prescription drugs.
(3) "Exigent circumstances" exist when an enrollee
is suffering from a health condition that may seriously jeopardize the enrollee's
life, health, or ability to regain maximum function or when an enrollee is
undergoing a current course of treatment using a nonformulary drug.
(4) "Step therapy exception" is the exception to
the step therapy process and the determination of whether the exception shall be
granted, taking into consideration the enrollee's needs and medical circumstances,
along with the professional judgment of the enrollee's provider.
(5) "Electronic I.D. Verification" is a unique
identification number that clearly identifies the prescribing provider on the
Prescription Drug Prior Authorization or Step Therapy Exception Request Form to
allow verification of the prescriber by the health plan or pharmacy benefit
manager.
(b) Health insurers
that utilize a prescription drug prior authorization or step therapy exception
request process shall utilize only the Request Form, or an electronic prior
authorization form or process as described in subdivision (c). Health insurers shall
not utilize or accept any prescription drug prior authorization form other than the
Request Form. This subdivision does not apply in the following circumstances:
(1) A contracted physician group is delegated the
financial risk for prescription drugs including step therapy by a health insurer;
or,
(2) A contracted physician group
uses its own internal prior authorization process rather than the health insurer's
prior authorization process for health insurer's insureds; or,
(3) A contracted physician group is delegated a
utilization management function by the health insurer concerning any prescription
drug or step therapy exception request, regardless of delegation of financial
risk.
(c) A prescribing
provider may use an electronic prior authorization system utilizing the Request Form
or an electronic process for prior authorizations that meets the National Council
for Prescription Drug Programs' SCRIPT standard for electronic prior authorization
transactions.
(d) Health insurers shall
do the following:
(1) Make the Request Form or a
form or process compliant with subdivision (c) electronically available on their
websites.
(2) Accept the Request Form or
a form or process compliant with subdivision (c) through any reasonable means of
transmission, including, but not limited to, paper, electronic, or another mutually
agreeable accessible method of transmission.
(3) Request from the prescribing provider only the
minimum amount of material information necessary to approve or disapprove the
prescription drug prior authorization or step therapy exception request.
(4) Notify the prescribing provider within 72
hours for non-urgent requests, and within 24 hours if exigent circumstances exist,
upon receipt of a completed Request Form or a form or process compliant with
subdivision (c) that:
(A) The prescribing
provider's request is approved;
(B) The
prescribing provider's request is disapproved as not medically necessary or not a
covered benefit;
(C) The prescribing
provider's request is disapproved as missing material information necessary to
approve or disapprove the request;
(D)
The patient is no longer eligible for coverage; or
(E) The request was not submitted on the required
form, and must be resubmitted using the approved Request Form or a form or process
compliant with subdivision (c).
(e) Notices to the prescribing provider required
under this section shall be delivered in the same manner as the request was
submitted, or another mutually agreeable accessible method of
notification.
(f) Prescription drug
prior authorization or step therapy exception request procedures conducted
telephonically, through a web portal, or any other manner of transmission, shall not
require the prescribing provider to provide more information than is required by the
Request Form or a form or process compliant with subdivision (c).
(g) In the event that the prescribing provider's
prescription drug prior authorization or step therapy exception request is
disapproved:
(1) Pursuant to subparagraph
(d)(4)(B) or (d)(4)(C), the notice of disapproval shall contain an accurate and
clear written explanation of the specific reasons for disapproving the prescription
drug prior authorization or step therapy exception request.
(2) Pursuant to subparagraph (d)(4)(C), the notice
of disapproval shall contain an accurate and clear written explanation that
specifically identifies the missing material information that is necessary to
approve or disapprove the prescription drug prior authorization or step therapy
exception request.
(h) In the
event that the notice of disapproval is not sent to the prescribing provider within
72 hours for non-urgent requests, and within 24 hours if exigent circumstances
exist, receipt of a completed prescription drug prior authorization or step therapy
exception request, or if a health insurer or its third party administrator either
fails to utilize only the Request Form or a form or process compliant with
subdivision (c), or accepts any prescription drug prior authorization form other
than the Request Form, the prescription drug prior authorization request shall be
deemed approved.
(i) If a health insurer
contracts with a third party administrator to conduct prescription drug prior
authorization services or step therapy exception requests, failure by the third
party administrator to comply with the requirements of this section or of Insurance
Code section
10123.191 and
section 10123.197 shall subject the health insurer to the remedies available under
Insurance Code section
10123.191,
section 10123.197, and this regulation.
(j) Review and Enforcement.
(1) Every health insurer that contracts with a
third party administrator to conduct prescription drug prior authorization services
or step therapy exception requests shall include a provision in its contract with
the third party administrator requiring the third party administrator to comply with
the requirements of Insurance Code section
10123.191,
section 10123.197, and this regulation.
(2) Every health insurer, and any third party
administrator that conducts prescription drug prior authorizations or step therapy
exception requests shall have written policies and procedures in place to ensure
that the insurer and its contracting entities comply with the requirements of
Insurance Code section
10123.191,
section 10123.197, and this regulation.
(3) Utilizing or accepting a drug specific form
other than the Request Form shall constitute a violation of subdivision
(b).
(4) Requiring information in excess
of the minimum material information specified by the Request Form shall constitute a
failure to utilize only the Request Form, in violation of subdivision (b). An
insurer may not disapprove a Request Form on grounds of missing information pursuant
to subparagraph (d)(4)(C) if the form provides the minimum amount of material
information pursuant to paragraph (d)(3).
(k) Prescription Drug Prior Authorization or Step
Therapy Exception Request Form (Revised 12/2016).
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1. New article
1.2 (section 2218.30) and section filed 2-25-2014; operative 4-1-2014 (Register
2014, No. 9).
2. Amendment of article heading, section heading, section
and Request Form filed 3-22-2017; operative 7-1-2017 (Register 2017, No.
12).
Note: Authority cited: Section
10123.191,
Insurance Code. Reference: Section
10123.191,
Insurance Code.
