S.B. No. 680

	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.
	______________________________	______________________________
	President of the Senate	Speaker of the House
	I hereby certify that S.B. No. 680 passed the Senate on
	April 3, 2017, by the following vote: Yeas 31, Nays 0; and that
	the Senate concurred in House amendment on May 16, 2017, by the
	following vote: Yeas 30, Nays 0.
	______________________________
	Secretary of the Senate
	I hereby certify that S.B. No. 680 passed the House, with
	amendment, on May 9, 2017, by the following vote: Yeas 144,
	Nays 2, one present not voting.
	______________________________
	Chief Clerk of the House
	Approved:
	______________________________
	Date
	______________________________
	Governor