85R23121 PMO-F
By: Hancock, et al. S.B. No. 680
(Bonnen of Galveston, Parker, Thompson of Harris, Bernal,
Villalba, et al.)
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 a multidisciplinary panel of experts
composed of physicians and, as necessary, other 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
clinical practice guidelines used by a health benefit plan issuer,
utilization review organization, or independent review
organization to determine the medical necessity and
appropriateness or the experimental or investigational nature 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 health benefit plan issuer shall take into account
the needs of atypical patient populations and diagnoses in
establishing the clinical review criteria. The clinical review
criteria:
(1) must consider generally accepted clinical
practice guidelines that are:
(A) developed and endorsed by a
multidisciplinary panel of experts described by Subsection (b);
(B) based on high quality studies, research, and
medical practice;
(C) created by an explicit and transparent
process that:
(i) minimizes bias and conflicts of
interest;
(ii) explains the relationship between
treatment options and outcomes;
(iii) rates the quality of the evidence
supporting the recommendations; and
(iv) considers relevant patient subgroups
and preferences; and
(D) 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, may be based on
peer-reviewed publications developed by independent experts, which
may include physicians, with expertise applicable to the relevant
health condition.
(b) A multidisciplinary panel of experts composed of
physicians and, as necessary, other health care providers 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) Subsection (b) does not apply to a panel or committee of
experts, including a pharmacy and therapeutics committee,
established by a health benefit plan issuer or a pharmacy benefit
manager that advises the health benefit plan issuer or pharmacy
benefit manager regarding drugs or formularies.
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 and
prescribing provider, in the health benefit plan's formulary
document and otherwise, 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 provider shall submit the request on the
standard form prescribed by the commissioner under Section
1369.304.
(c) A health benefit plan issuer shall grant a written
request under Subsection (b) if the request includes the
prescribing provider's written statement, with supporting
documentation, 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)(A) the drug that is subject to the step therapy
protocol was prescribed for the patient's condition;
(B) the patient:
(i) received benefits for the drug under
the health benefit plan currently in force or a previous health
benefit plan; and
(ii) is stable on the drug; and
(C) the change in the patient's prescription drug
regimen required by the step therapy protocol is expected to be
ineffective or cause harm to the patient based on the known clinical
characteristics of the patient and the known characteristics of the
required prescription drug regimen.
(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, if appropriate,
other health care provider deciding the appeal must consider
atypical diagnoses and the needs of atypical patient populations.
SECTION 4. Section 4202.003, Insurance Code, is amended to
read as follows:
Sec. 4202.003. REQUIREMENTS REGARDING TIMELINESS OF
DETERMINATION. 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, or a review of a step therapy
protocol exception request under Section 1369.0546, 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.
SECTION 5. 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 6. This Act takes effect September 1, 2017.