By: Raymond H.B. No. 3732
A BILL TO BE ENTITLED
AN ACT
relating to prescription drug benefits under the Medicaid program.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Section 531.073(a), Government Code, is amended
to read as follows:
(a) The executive commissioner, in the rules and standards
governing the Medicaid vendor drug program and the child health
plan program, shall require prior authorization for the
reimbursement of a drug that is not included in the appropriate
preferred drug list adopted under Section 531.072, except as
provided by Section 531.0731 and for any drug exempted from prior
authorization requirements by federal law. Except as provided by
Section 531.0731, the [The] executive commissioner may require
prior authorization for the reimbursement of a drug provided
through any other state program administered by the commission or a
state health and human services agency, including a community
mental health center and a state mental health hospital if the
commission adopts preferred drug lists under Section 531.072 that
apply to those facilities and the drug is not included in the
appropriate list. The executive commissioner shall require that the
prior authorization be obtained by the prescribing physician or
prescribing practitioner.
SECTION 2. Subchapter B, Chapter 531, Government Code, is
amended by adding Section 531.0731 to read as follows:
Sec. 531.0731. CONTINUITY OF CARE IN RELATION TO
PRESCRIPTION DRUGS. The commission shall ensure that a
prescription drug prescribed to a person who is newly enrolled in
the child health plan program, Medicaid, or another state program
administered by the commission or a health and human services
agency, or who is newly enrolled in a Medicaid managed care health
plan, is not subject to a prior authorization requirement for up to
one year after the date of the person's enrollment, if:
(1) the patient had previously been prescribed the
drug to treat a medical condition; and
(2) the person's physician prescribes the drug to
treat the person's medical condition based on the physician's
determination that the prescription is the most appropriate course
of treatment for the medical condition.
SECTION 3. Section 531.0736, Government Code, is amended by
amending Subsection (b) to read as follows:
(b) In addition to performing any other duties required by
federal law, the board shall:
(1) develop and submit to the commission
recommendations for preferred drug lists adopted by the commission
under Section 531.072;
(2) suggest to the commission restrictions or clinical
edits on prescription drugs in accordance with Section 531.0738;
(3) review existing restrictions or clinical edits on
prescription drugs for appropriateness in accordance with Section
531.0738;
(4) recommend to the commission educational
interventions for Medicaid providers;
(5) [(4)] review drug utilization across Medicaid;
and
(6) [(5)] perform other duties that may be specified
by law and otherwise make recommendations to the commission.
SECTION 4. Subchapter B, Chapter 531, is amended by adding
Sections 531.0738, 531.07381, 531.07382, and 531.07383 to read as
follows:
Sec. 531.0738. DRUG UTILIZATION REVIEW BOARD: SUGGESTION
AND REVIEW OF RESTRICTIONS AND CLINICAL EDITS. (a) In performing
the requirements under Sections 531.0736(b)(2) and (3), the board
shall evaluate the appropriateness of and make a recommendation
regarding a restriction or clinical edit or protocol on a
prescription drug. The committee's evaluation and recommendation
must:
(1) be based on only a determination of the safety and
efficacy of the restriction or clinical edit or protocol;
(2) ensure the restriction or clinical edit is written
for the needs of all applicable populations, including pediatric
and obstetric populations; and
(3) include an explanation of the basis for the
committee's recommendation that is written in such a way that would
allow a person without medical training to understand.
(b) To perform the requirements under Section
531.0736(b)(3), the board shall establish a periodic review
schedule for existing restrictions or clinical edits or protocols.
The schedule must require review of a restriction or clinical edit
on a prescription drug no less frequently than once every two years.
A restriction or clinical edit on a prescription drug has no effect
and may not be enforced beginning on the date of the second
anniversary of the most recent review of the restriction or edit by
the board unless the restriction or clinical edit has been
evaluated and renewed by the board.
(c) In determining the safety and efficacy of a restriction
or clinical edit, the board:
(1) may consider public comment or clinical
information including scientific evidence, standards of practice,
peer-reviewed medical literature, randomized clinical trials,
pharmacoeconomic studies, and outcomes research data; and
(2) may not rely solely on manufacturer package
inserts.
Sec. 531.07381. SUSPENSION OF RESTRICTION OR CLINICAL EDIT
ON PRESCRIPTION DRUG. The executive commissioner by rule shall
adopt a process by which the commission amends or suspends a
restriction or clinical edit on a prescription drug. The process
must:
(1) allow providers or Medicaid managed care
organization medical or pharmacy directors to submit to the
commission evidence that the restriction or clinical edit:
(A) jeopardizes patient safety or care by
imposing undue administrative burdens to patients or providers; or
(B) is clinically inaccurate or otherwise
inappropriate;
(2) require the commission's Medicaid medical director
to:
(A) review submitted clinical information to
determine whether the restriction or clinical edit should be
amended or suspended in the interest of patient safety or care; and
(B) submit a recommendation based on the medical
director's determination regarding the restriction or clinical
edit to the executive commissioner; and
(3) no later than 10 business days after the date the
executive commissioner receives the medical director's
recommendation), require the executive commissioner to amend or
suspend the restriction or clinical edit in accordance with the
medical director's determination, as applicable.
Sec. 531.07382. STEP THERAPY PROTOCOLS. (a) In this
section and in Section 531.07383:
(1) "Clinical practice guideline" means a statement
systematically developed by physicians and 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.
(2) "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.
(3) "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.
(b) The commission may require a step therapy protocol
before providing coverage for a prescription drug only if the
commission establishes, implements, and administers 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, which must include
physicians, with expertise applicable to the relevant health
condition.
(c) A multidisciplinary panel of experts consisting of
physicians and 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, managed care
organization, 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.
(d) This section may not be construed to prohibit:
(1) the commission from requiring a patient to try an
AB-rated generic equivalent drug before providing coverage for the
equivalent branded prescription drug, unless the drug:
(A) has been demonstrated to be ineffective on
the patient;
(B) has caused an adverse reaction in or physical
or mental harm to the patient; or
(C) is likely to cause an adverse reaction in or
physical or mental harm to the patient; or
(2) a prescribing provider from prescribing a
prescription drug that is determined to be medically appropriate.
Sec. 531.07383. OVERRIDE OF RESTRICTIONS ON MEDICATION
SEQUENCE IN STEP THERAPY PROTOCOL. (a) The commission shall
establish a clear and convenient process for a prescribing health
professional to request electronically, in writing, or by phone an
override of a step therapy protocol.
(b) The commission shall grant a request for an override of
a step therapy protocol to a prescribing health professional
within, subject to Subsections (c) and (d), a reasonable time after
the health professional completes the process for the request of
the override, if:
(1) the prescribing health professional can
demonstrate that the patient has previously failed the preferred
treatment required under the step therapy protocol, or that the
preferred treatment or another drug in the same pharmacologic class
or with the same mechanism of action as the preferred treatment, has
been ineffective or had a diminished effect for the treatment of a
recipient's medical condition after two attempts of following the
protocol; or
(2) based on sound clinical evidence or medical and
scientific evidence, the prescribing health professional can
demonstrate that the preferred treatment required under the step
therapy protocol:
(A) is expected or likely to be ineffective based
on the known relevant physical or mental characteristics of the
recipient and known characteristics of the drug regimen; or
(B) will cause or will likely cause an adverse
reaction in or physical or mental harm to the recipient.
(c) Except as provided by Subsection (e), if the commission
does not deny an exception request described by Subsection (a)
before 48 hours after the commission receives the request, the
request is considered granted.
(d) 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 commission
does not deny the request before 24 hours after the organization
receives the request.
(e) The process established under this section must allow a
prescribing health professional to appeal a denial of a request for
an override of a step therapy protocol to the commission's medical
director.
SECTION 5. Section 531.0741, Government Code, is amended to
read as follows:
Sec. 531.0741. PUBLICATION OF INFORMATION REGARDING
COMMISSION AND DRUG UTILIZATION REVIEW BOARD DECISIONS [ON
PREFERRED DRUG LIST PLACEMENT]. (a) The commission shall publish
on the commission's Internet website any decisions on preferred
drug list placement, including:
(1) a list of drugs reviewed and the commission's
decision for or against placement on a preferred drug list of each
drug reviewed;
(2) for each recommendation, whether a supplemental
rebate agreement or a program benefit agreement was reached under
Section 531.070; and
(3) the rationale for any departure from a
recommendation of the Drug Utilization Review Board under Section
531.0736.
(b) The commission shall publish on the commission's
Internet website in a section of the website dedicated to
prescription drug information:
(1) information on restrictions or clinical edits for
a prescription drug, including a preferred drug, including the
evaluation and recommendation required under Section 531.0738 that
relates to the restriction or clinical edit; and
(2) the periodic review schedule established under
Section 531.0738(b).
(c) The commission must publish the information required
under this section in a manner that would allow a provider to search
a preferred drug list to easily determine whether a prescription
drug or drug class is subject to any restrictions or clinical edits.
SECTION 6. Subchapter B, Chapter 531, Government Code is
amended by adding Section 531.0761 to read as follows:
Sec. 531.0761. PRESCRIPTION OF GENERIC EQUIVALENTS. (a)
Notwithstanding any other section of law and in a manner that
complies with applicable federal law, the commission shall ensure
that a preferred drug list adopted by the commission for the
Medicaid vendor drug program and for prescription drugs purchased
through the child health plan program establishes a generic
equivalent of a prescribed drug as a preferred drug.
(b) If a physician or other health care practitioner acting
within the practitioner's scope of delegated authority writes a
prescription for a generic equivalent of a prescribed drug, the
commission may not require the physician or practitioner to specify
the national drug code on the prescription.
Sec. 531.0762. UPDATING NATIONAL DRUG CODES. (a) No later
than the 15th business day after the day the commission receives
notice from the Centers for Medicaid and Medicare Services that a
National Drug Code has been eliminated or changed, the commission
shall update its electronic database and notify Medicaid managed
care organizations.
SECTION 7. Subchapter A, Chapter 533, Government Code, is
amended by adding Section 533.022 to read as follows:
Sec. 533.022. PHARMACY BENEFIT PLAN REQUIREMENTS. (a) The
commission shall require that the pharmacy benefit plan of a
managed care organization that contracts with the commission to
provide health care services to recipients must:
(1) adopt the restrictions or clinical edits as
recommended by the Drug Utilization Review Board under Section
531.0738 and impose no other restrictions or clinical edits than
those recommended by the board;
(2) adopt the process adopted under Section 531.07381
for amending or suspending a restriction or clinical edit on a
prescription drug;
(3) adhere to the step therapy guidelines and override
procedures under Sections 531.07382 and 531.07383, including a
procedure for an appeal under Section 531.07383(e) to the managed
care organization's medical director.
SECTION 8. Section 533.005(a-1), Government Code, is
amended to read as follows:
(a-1) The requirements imposed by Subsections (a)(23)(A),
(B), and (C) do not apply, and may not be enforced, on and after
August 31, 2030 [2018].
SECTION 9. If before implementing any provision of this Act
a state agency determines that a waiver or authorization from a
federal agency is necessary for implementation of that provision,
the agency affected by the provision shall request the waiver or
authorization and may delay implementing that provision until the
waiver or authorization is granted.
SECTION 10. (a) The Drug Utilization Review Board shall
establish a schedule for reviewing restrictions and clinical edits
on prescription drugs provided as benefits under the Medicaid
program as required by Section 531.0738, Government Code, as added
by this Act, no later than March 1, 2018.
(b) The Drug Utilization Review Board shall complete a
review of all restrictions and clinical edits on prescription drugs
that are provided as benefits under the Medicaid program that are in
effect on the effective date of this Act, as required by Section
531.0738, Government Code, as added by this Act, no later than
September 1, 2018.
(c) The Health and Human Services Commission may not allow a
restriction or clinical edit on a prescription drug provided as a
benefit under the Medicaid program to be enforced or to have any
effect before the Drug Utilization Review Board reviews the
restriction or clinical edit in accordance with Subsection (b) of
this SECTION, unless the Health and Human Services Commission
requires the enforcement or imposition of the restriction or
clinical edit by administrative rule or by contract with a managed
care organization that contracts with the commission to provide
health care benefits to enrollees in the Medicaid program.
SECTION 11. This Act takes effect immediately if it
receives a vote of two-thirds of all the members elected to each
house, as provided by Section 39, Article III, Texas Constitution.
If this Act does not receive the vote necessary for immediate
effect, this Act takes effect September 1, 2017.