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.