(1)
As used in this section:
(a) Biosimilar has the meaning set forth in 42 U.S.C. sec. 262 (i)(2).
(b) Clinical practice guidelines means a systematically developed
statement to assist providers and covered persons in making decisions about
appropriate health care for specific clinical circumstances and conditions.
(c) Clinical review criteria means the written screening procedures,
decision abstracts, clinical protocols, and clinical practice guidelines used by a
carrier or private utilization review organization to determine the medical necessity
and appropriateness of the provision of health-care services. Clinical review criteria
must not be more restrictive than the FDA's indication for a specific drug or health-care service.
(d) Exigent circumstance means a circumstance in which a covered person
is suffering from a health condition that may seriously jeopardize the covered
person's life, health, or ability to regain maximum functions.
(e) Medical necessity has the same meaning as set forth in section 10-16-112.5.
(f) Private utilization review organization or organization has the same
meaning as set forth in section 10-16-112 (1)(a).
(f.5) Serious mental illness means the following psychiatric illnesses, as
defined by the American Psychiatric Association in the most recent version of the
Diagnostic and Statistical Manual of Mental Disorders:
(I) Bipolar disorders (hypomanic, manic, depressive, and mixed);
(II) Depression in childhood and adolescence;
(III) Major depressive disorders (single episode or recurrent);
(IV) Obsessive-compulsive disorders;
(V) Paranoid and other psychotic disorders;
(VI) Schizoaffective disorders (bipolar or depressive); and
(VII) Schizophrenia.
(g) Step therapy means a protocol that requires a covered person to use a
prescription drug or sequence of prescription drugs, other than the drug that the
covered person's health-care provider recommends for the covered person's
treatment, before the carrier provides coverage for the recommended prescription
drug.
(2) If a carrier, a private utilization review organization, or a PBM requires
step therapy, the carrier, organization, or PBM shall use clinical review criteria to
establish the protocol for step therapy based on clinical practice guidelines.
(3) A carrier, a private utilization review organization, or a PBM shall:
(a) Make the clinical review criteria and the step-therapy exemption process
available on their websites; and
(b) Upon written request, provide all specific clinical review criteria and other
clinical information relating to a covered person's particular condition or disease,
including clinical review criteria relating to a step-therapy exception, to the
requester.
(4) (a) A carrier, a private utilization review organization, or a PBM shall grant
an exception to step therapy if the prescribing provider submits justification and
supporting clinical documentation, if needed, that states:
(I) The provider attests that the required prescription drug is contraindicated
or will likely cause an adverse reaction or harm to the covered person;
(II) The required prescription drug is ineffective based on the known clinical
characteristics of the covered person and the known characteristics of the
prescription drug regimen;
(III) The covered person has tried, while under the covered person's current
or previous health benefit plan, the required prescription drug or another
prescription drug in the same pharmacologic class or with the same mechanism of
action, and the use of the prescription drug by the covered person was discontinued
due to lack of efficacy or effectiveness, diminished effect, or an adverse event;
(IV) The covered person, while on the covered person's current or previous
health benefit plan, is stable on a prescription drug selected by the prescribing
provider for the medical condition under consideration after undergoing step
therapy or after having sought and received a step-therapy exception.
(b) (I) Except as provided in subsection (4)(b)(II) of this section, a carrier, an
organization, or a PBM shall grant or deny a step-therapy exception request or an
appeal of a denial of a request within:
(A) Three business days after receipt of the request; or
(B) In cases where exigent circumstances exist, within twenty-four hours
after receipt of the request.
(II) If a request for a step-therapy exception or an appeal of a denial of a
request is incomplete or if additional clinically relevant information is required, the
carrier, organization, or PBM shall notify the prescribing provider within seventy-two hours after submission of the request, or within twenty-four hours after the
submission of the request if exigent circumstances exist, that the request or appeal
is incomplete or that additional clinically relevant information is required. The
carrier, organization, or PBM must specify the additional information that is
required in order to consider the step-therapy exception request or the appeal of
the denial of the request pursuant to the criteria described in subsection (4)(a) of
this section. Once the requested information is submitted to the carrier,
organization, or PBM, the applicable period to grant or deny a step-therapy
exception request or an appeal of a denial of a request, as specified in subsection
(4)(b)(I) of this section, applies.
(III) If a carrier, an organization, or a PBM does not make a determination
regarding the step-therapy exception request or the appeal of the denial of the
request or does not make a request for additional or clinically relevant information
within the required time, the step-therapy exception request or the appeal of the
denial of the request is deemed granted.
(c) If the initial request for a step-therapy exception is denied, the carrier,
organization, or PBM shall inform the covered person in writing that the covered
person has the right to an internal or external review or an appeal of the adverse
determination pursuant to sections 10-16-113 and 10-16-113.5.
(d) A carrier, an organization, or a PBM shall authorize coverage for the
prescription drug prescribed by the covered person's prescribing provider when the
step-therapy exception request is granted.
(4.5) With respect to a covered drug prescribed for serious mental illness:
(a) If, under a health benefit plan, a carrier, a private utilization review
organization, or a PBM requires step therapy, the step therapy may only require a
covered person to try one prescription drug other than the drug prescribed by the
provider prior to providing coverage to the covered person for the drug prescribed
by the covered person's provider.
(b) Notwithstanding subsection (4.5)(a) of this section, if a covered person's
provider attests on a form established by the division that any of the criteria
specified in subsections (4)(a)(I) to (4)(a)(IV) of this section are met, the carrier,
private utilization review organization, or PBM must cover the drug prescribed by
the covered person's provider without requiring step therapy.
(5) This section does not prohibit:
(a) A carrier, an organization, or a PBM from requiring a covered person to try
a generic equivalent drug, a biosimilar drug, or an interchangeable biological
product as defined by 42 U.S.C. sec. 262 (i)(3), unless the covered person or covered
person's prescribing provider has requested a step-therapy exception and the
prescribed drug meets the criteria for a step-therapy exception specified in
subsection (4)(a) of this section;
(b) A carrier, an organization, or a PBM from requiring a pharmacist to make
substitutions of prescription drugs consistent with part 5 of article 280 of title 12;
or
(c) A provider from prescribing a drug that is determined to be medically
appropriate.
(6) The commissioner may promulgate rules to implement and enforce this
section.