85R6725 PMO-F
By: Hancock S.B. No. 680
A BILL TO BE ENTITLED
AN ACT
relating to step therapy protocols required by a health benefit
plan in connection with prescription drug coverage.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Section 1369.051, Insurance Code, is amended by
amending Subdivision (1) and adding Subdivisions (1-a), (1-b), and
(5) to read as follows:
(1) "Clinical practice guideline" means a statement
systematically developed by health care providers to assist a
patient or health care provider in making a decision about
appropriate health care for a specific clinical circumstance or
condition.
(1-a) "Clinical review criteria" means the written
screening procedures, decision abstracts, clinical protocols, and
practice guidelines used by a health benefit plan issuer,
utilization review organization, or independent review
organization to determine the medical necessity and
appropriateness of a health care service or prescription drug.
(1-b) "Drug formulary" means a list of drugs:
(A) for which a health benefit plan provides
coverage;
(B) for which a health benefit plan issuer
approves payment; or
(C) that a health benefit plan issuer encourages
or offers incentives for physicians to prescribe.
(5) "Step therapy protocol" means a protocol that
requires an enrollee to use a prescription drug or sequence of
prescription drugs other than the drug that the enrollee's
physician recommends for the enrollee's treatment before the health
benefit plan provides coverage for the recommended drug.
SECTION 2. Subchapter B, Chapter 1369, Insurance Code, is
amended by adding Sections 1369.0545 and 1369.0546 to read as
follows:
Sec. 1369.0545. STEP THERAPY PROTOCOLS. (a) A health
benefit plan issuer that requires a step therapy protocol before
providing coverage for a prescription drug must establish,
implement, and administer the step therapy protocol in accordance
with clinical review criteria readily available to the health care
industry. The clinical review criteria must be based on:
(1) generally accepted clinical practice guidelines
that are:
(A) developed and endorsed by a
multidisciplinary panel of experts described by Subsection (b); and
(B) based on high quality studies, research, and
medical practice that are:
(i) created by an explicit and transparent
process that:
(a) minimizes bias and conflicts of
interest;
(b) explains the relationship between
treatment options and outcomes;
(c) rates the quality of the evidence
supporting the recommendations; and
(d) considers relevant patient
subgroups and preferences; and
(ii) updated at appropriate intervals after
a review of new evidence, research, and treatments; or
(2) if clinical practice guidelines described by
Subdivision (1) are not reasonably available, peer-reviewed
publications developed by independent experts with expertise
applicable to the relevant health condition.
(b) A multidisciplinary panel of experts that develops and
endorses clinical practice guidelines under Subsection (a)(1) must
manage conflicts of interest by:
(1) requiring each member of the panel's writing or
review group to:
(A) disclose any potential conflict of interest,
including a conflict of interest involving an insurer, health
benefit plan issuer, or pharmaceutical manufacturer; and
(B) recuse himself or herself in any situation in
which the member has a conflict of interest;
(2) using a methodologist to work with writing groups
to provide objectivity in data analysis and the ranking of evidence
by preparing evidence tables and facilitating consensus; and
(3) offering an opportunity for public review and
comment.
(c) This section may not be construed to prohibit:
(1) a health benefit plan issuer from requiring a
patient to try an AB-rated generic equivalent drug before providing
coverage for the equivalent branded prescription drug; or
(2) a prescribing provider from prescribing a
prescription drug that is determined to be medically appropriate.
Sec. 1369.0546. STEP THERAPY PROTOCOL EXCEPTION REQUESTS.
(a) A health benefit plan issuer shall establish a process in a
user-friendly format that is readily accessible to a patient or
prescribing provider through which an exception request under this
section may be submitted by the provider.
(b) A prescribing provider on behalf of a patient may submit
to the patient's health benefit plan issuer a written request for an
exception to a step therapy protocol required by the patient's
health benefit plan. The commissioner by rule shall prescribe the
form of the written request.
(c) A health benefit plan issuer shall grant a written
request under Subsection (b) if the request includes the
prescribing provider's written statement stating that:
(1) the drug required under the step therapy protocol:
(A) is contraindicated;
(B) will likely cause an adverse reaction in or
physical or mental harm to the patient; or
(C) is expected to be ineffective based on the
known clinical characteristics of the patient and the known
characteristics of the prescription drug regimen;
(2) the patient previously discontinued taking the
drug required under the step therapy protocol, or another
prescription drug in the same pharmacologic class or with the same
mechanism of action as the required drug, while under the health
benefit plan currently in force or while covered under another
health benefit plan because the drug was not effective or had a
diminished effect or because of an adverse event;
(3) the drug required under the step therapy protocol
is not in the best interest of the patient, based on clinical
appropriateness, because the patient's use of the drug is expected
to:
(A) cause a significant barrier to the patient's
adherence to or compliance with the patient's plan of care;
(B) worsen a comorbid condition of the patient;
or
(C) decrease the patient's ability to achieve or
maintain reasonable functional ability in performing daily
activities; or
(4) the drug that is subject to the step therapy
protocol was prescribed for the patient's condition while under the
health benefit plan currently in force or a previous health benefit
plan and the patient is stable on the drug.
(d) Except as provided by Subsection (e), if a health
benefit plan issuer does not deny an exception request described by
Subsection (c) before 72 hours after the health benefit plan issuer
receives the request, the request is considered granted.
(e) If an exception request described by Subsection (c) also
states that the prescribing provider reasonably believes that
denial of the request makes the death of or serious harm to the
patient probable, the request is considered granted if the health
benefit plan issuer does not deny the request before 24 hours after
the health benefit plan issuer receives the request.
(f) The denial of an exception request under this section is
an adverse determination for purposes of Section 4201.002 and is
subject to appeal under Subchapters H and I, Chapter 4201.
SECTION 3. Section 4201.357, Insurance Code, is amended by
adding Subsection (a-2) to read as follows:
(a-2) An adverse determination under Section 1369.0546 is
entitled to an expedited appeal. The physician or other health care
provider deciding the appeal must consider atypical diagnoses and
the needs of atypical patient populations.
SECTION 4. Section 4201.402, Insurance Code, is amended by
amending Subsection (a) and adding Subsection (a-1) to read as
follows:
(a) Except as provided by Subsection (a-1), not [Not] later
than the third business day after the date a utilization review
agent receives a request for independent review, the agent shall
provide to the appropriate independent review organization:
(1) a copy of:
(A) any medical records of the enrollee that are
relevant to the review;
(B) any documents used by the plan in making the
determination to be reviewed;
(C) the written notification described by
Section 4201.359; and
(D) any documents and other written information
submitted to the agent in support of the appeal; and
(2) a list of each physician or other health care
provider who:
(A) has provided care to the enrollee; and
(B) may have medical records relevant to the
appeal.
(a-1) For the independent review of a step therapy protocol
exception request described by Section 1369.0546(e), the
utilization review agent shall provide the information described
by Subsection (a) to the appropriate independent review
organization not later than 24 hours after the agent receives the
request for independent review.
SECTION 5. Section 4202.003, Insurance Code, is amended to
read as follows:
Sec. 4202.003. REQUIREMENTS REGARDING TIMELINESS OF
DETERMINATION. (a) Except as provided by Subsection (b), the [The]
standards adopted under Section 4202.002 must require each
independent review organization to make the organization's
determination:
(1) for a life-threatening condition as defined by
Section 4201.002 or the provision of prescription drugs or
intravenous infusions for which the patient is receiving benefits
under the health insurance policy, not later than the earlier of the
third day after the date the organization receives the information
necessary to make the determination or, with respect to:
(A) a review of a health care service provided to
a person with a life-threatening condition eligible for workers'
compensation medical benefits, the eighth day after the date the
organization receives the request that the determination be made;
or
(B) a review of a health care service other than a
service described by Paragraph (A), the third day after the date the
organization receives the request that the determination be made;
or
(2) for a situation other than a situation described
by Subdivision (1), not later than the earlier of:
(A) the 15th day after the date the organization
receives the information necessary to make the determination; or
(B) the 20th day after the date the organization
receives the request that the determination be made.
(b) For a review of a step therapy protocol exception
request under Section 1369.0546, the standards adopted under
Section 4202.002 must require each independent review organization
to make the organization's determination not later than:
(1) except as provided by Subdivision (2), 72 hours
after the organization receives the request that the determination
be made; or
(2) for a determination of an exception request
described by Section 1369.0546(e), 24 hours after the organization
receives the request that the determination be made.
SECTION 6. The changes in law made by this Act apply only to
a health benefit plan that is delivered, issued for delivery, or
renewed on or after January 1, 2018. A health benefit plan
delivered, issued for delivery, or renewed before January 1, 2018,
is governed by the law as it existed immediately before the
effective date of this Act, and that law is continued in effect for
that purpose.
SECTION 7. This Act takes effect September 1, 2017.