81R12529 T
By: King of Taylor H.B. No. 3719
A BILL TO BE ENTITLED
AN ACT
relating to preferred drug lists, including confidentiality,
supplemental rebate, prior approval and publication requirements.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Chapter 531, Subtitle I, Title 4, Government
Code is amended to read as follows:
Sec. 531.071. CONFIDENTIALITY OF INFORMATION REGARDING
DRUG REBATES, PRICING, AND NEGOTIATIONS. (a) Notwithstanding any
other state law, financial information obtained or maintained by
the commission regarding prescription drug rebate negotiations or a
supplemental medical assistance or other rebate agreement,
including trade secrets, rebate amount, rebate percentage, and
manufacturer or labeler pricing, is confidential and not subject to
disclosure under Chapter 552.
(b) Information that is confidential under Subsection (a)
includes information described by Subsection (a) that is obtained
or maintained by the commission in connection with the Medicaid
vendor drug program, the child health plan program, the kidney
health care program, the children with special health care needs
program, or another state program administered by the commission or
a health and human services agency.
(c) Notwithstanding Subsection (a), the following
information is not confidential:
(1) general information about the aggregate costs of
different classes of drugs; [is not confidential under Subsection
(a).]
(2) the fact that a supplemental rebate agreement was
or was not reached between the commission and a manufacturer or
labeler for a particular drug; and
(3) the fact that a supplemental rebate agreement for
a particular drug was or was not of a sufficient amount to make the
drug cost-effective for preferred drug list placement, without
disclosing the amount of the rebate or other confidential financial
information described in this Section.
Sec. 531.072. PREFERRED DRUG LISTS. (a) In a manner that
complies with applicable state and federal law, the commission
shall adopt preferred drug lists for the Medicaid vendor drug
program and for prescription drugs purchased through the child
health plan program. The commission may adopt preferred drug lists
for community mental health centers, state mental health hospitals,
and any other state program administered by the commission or a
state health and human services agency.
(b) The preferred drug lists may contain only drugs provided
by a manufacturer or labeler that reaches an agreement with the
commission on supplemental rebates under Section 531.070 unless one
of the following exceptions is met:
(1) the commission determines that the drug provided
by a generic manufacturer or labeler without a supplemental rebate
is as or more cost-effective than a drug provided by a brand name
manufacturer or labeler who has reached a supplemental rebate
agreement with the commission in the same drug class;
(2) a public benefit agreement as described in Section
531.070 has been reached by the commission and a labeler or
manufacturer;
(b-1) Placement of a drug on the preferred drug list shall
include all strengths and dosages
(b-2) Each drug class shall include multiple methods of
delivery of the drug, including liquid, tablet, capsule, and orally
disintegrating tablets.
(c) In making a decision regarding the placement of a drug
on each of the preferred drug lists, the commission shall consider:
(1) the recommendations of the Pharmaceutical and
Therapeutics Committee established under Section 531.074;
(2) the clinical efficacy of the drug;
(3) the price of competing drugs after deducting any
federal and state rebate amounts; and
(4) program benefit offerings solely or in conjunction
with rebates and other pricing information.
(d) The commission shall provide for the distribution of
current copies of the preferred drug lists by posting the list on
the Internet. In addition, the commission shall mail copies of the
lists to any health care provider on request of that provider.
(e) In this subsection, "labeler" and "manufacturer" have
the meanings assigned by Section 531.070. The commission shall
ensure that:
(1) a manufacturer or labeler may submit written
evidence supporting the inclusion of a drug on the preferred drug
lists before a supplemental agreement is reached with the
commission; and
(2) any drug that has been approved or has had any of
its particular uses approved by the United States Food and Drug
Administration under a priority review classification will be
reviewed by the Pharmaceutical and Therapeutics Committee at the
next regularly scheduled meeting of the committee. On receiving
notice from a manufacturer or labeler of the availability of a new
product, the commission, to the extent possible, shall schedule a
review for the product at the next regularly scheduled meeting of
the committee.
(f) A recipient of drug benefits under the Medicaid vendor
drug program may appeal a denial of prior authorization under
Section 531.073 of a covered drug or covered dosage through the
Medicaid fair hearing process.
(g) Provided that one year has passed since the last review
of the drug or its drug class, a generic manufacturer or labeler may
make an application or request to have its drug reconsidered for
preferred drug placement based upon satisfaction of the
cost-effectiveness exception described in Section 531.072(b)(1).
Sec. 531.073. PRIOR AUTHORIZATION FOR CERTAIN PRESCRIPTION
DRUGS. (a) The commission, in its 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 for any drug exempted from prior
authorization requirements by federal law. The commission 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 commission shall require that the prior
authorization be obtained by the prescribing physician or
prescribing practitioner.
(a-1) Until the commission has completed a study evaluating
the impact of a requirement of prior authorization on recipients of
certain drugs, the commission shall delay requiring prior
authorization for drugs that are used to treat patients with
illnesses that:
(1) are life-threatening;
(2) are chronic; and
(3) require complex medical management strategies.
(a-2) Not later than the 30th day before the date on which
prior authorization requirements are implemented, the commission
shall post on the Internet for consumers and providers:
(1) a notification of the implementation date; and
(2) a detailed description of the procedures to be
used in obtaining prior authorization.
(b) The commission shall establish procedures for the prior
authorization requirement under the Medicaid vendor drug program to
ensure that the requirements of 42 U.S.C. Section 1396r-8(d)(5) and
its subsequent amendments are met. Specifically, the procedures
must ensure that:
(1) a prior authorization requirement is not imposed
for a drug before the drug has been considered at a meeting of the
Pharmaceutical and Therapeutics Committee established under
Section 531.074;
(2) there will be a response to a request for prior
authorization by telephone or other telecommunications device
within 24 hours after receipt of a request for prior authorization;
and
(3) a 72-hour supply of the drug prescribed will be
provided in an emergency or if the commission does not provide a
response within the time required by Subdivision (2).
(c) The commission shall ensure that a prescription drug
prescribed before implementation of a prior authorization
requirement for that drug for a recipient under the child health
plan program, the Medicaid program, or another state program
administered by the commission or a health and human services
agency or for a person who becomes eligible under the child health
plan program, the Medicaid program, or another state program
administered by the commission or a health and human services
agency is not subject to any requirement for prior authorization
under this section unless the recipient has exhausted all the
prescription, including any authorized refills, or a period
prescribed by the commission has expired, whichever occurs first.
(d) The commission shall implement procedures to ensure
that a recipient under the child health plan program, the Medicaid
program, or another state program administered by the commission or
a person who becomes eligible under the child health plan program,
the Medicaid program, or another state program administered by the
commission or a health and human services agency receives
continuity of care in relation to certain prescriptions identified
by the commission.
(e) The commission may by contract authorize a private
entity to administer the prior authorization requirements imposed
by this section on behalf of the commission.
(f) The commission shall ensure that the prior
authorization requirements are implemented in a manner that
minimizes the cost to the state and any administrative burden
placed on providers.
(g) The commission shall ensure that prior approval claims
submission occurs through multiple telecommunication modes,
including electronic point-of-sale submission, telephonic
submission, fax submission, and electronic communications via the
Internet.
Sec. 531.074. PHARMACEUTICAL AND THERAPEUTICS COMMITTEE.
(a) The Pharmaceutical and Therapeutics Committee is established
for the purposes of developing recommendations for preferred drug
lists adopted by the commission under Section 531.072.
(b) The committee consists of the following members
appointed by the governor:
(1) six physicians licensed under Subtitle B, Title 3,
Occupations Code, and participating in the Medicaid program, at
least one of whom is a licensed physician who is actively engaged in
mental health providing care and treatment to persons with severe
mental illness and who has practice experience in the state
Medicaid plan; and
(2) five pharmacists licensed under Subtitle J, Title
3, Occupations Code, and participating in the Medicaid vendor drug
program.
(c) In making appointments to the committee under
Subsection (b), the governor shall ensure that the committee
includes physicians and pharmacists who:
(1) represent different specialties and provide
services to all segments of the Medicaid program's diverse
population;
(2) have experience in either developing or practicing
under a preferred drug list; and
(3) do not have contractual relationships, ownership
interests, or other conflicts of interest with a pharmaceutical
manufacturer or labeler or with an entity engaged by the commission
to assist in the development of the preferred drug lists or the
administration of the prior authorization system.
(d) A member of the committee is appointed for a two-year
term and may serve more than one term.
(e) The governor shall appoint a physician to be the
presiding officer of the committee. The presiding officer serves at
the pleasure of the governor.
(f) The committee shall meet at least monthly during the
six-month period following establishment of the committee to enable
the committee to develop recommendations for the initial preferred
drug lists. After that period, the committee shall meet at least
quarterly and at other times at the call of the presiding officer or
a majority of the committee members.
(g) A member of the committee may not receive compensation
for serving on the committee but is entitled to reimbursement for
reasonable and necessary travel expenses incurred by the member
while conducting the business of the committee, as provided by the
General Appropriations Act.
(h) In developing its recommendations for the preferred
drug lists, the committee shall consider the clinical efficacy,
safety, and cost-effectiveness and any program benefit associated
with a product.
(i) The commission shall adopt rules governing the
operation of the committee, including rules:
(1) governing the procedures used by the committee for
providing notice of a meeting; [and]
(2) [rules] prohibiting the committee from discussing
confidential financial information described by Section 531.071 in
a public meeting; and [The committee shall comply with the rules
adopted under this subsection.]
(3) requiring the committee or its delegate to present
in oral and written form, at the public meeting, a summary of any
clinical efficacy and safety information or analyses provided to
the committee by a private entity that has contracted with the
commission to provide such information. Confidential financial
information described in Section 531.071 shall be omitted from the
summary. The written summary shall be posted to the Internet.
(j) To the extent feasible, the committee shall review all
drug classes included in the preferred drug lists adopted under
Section 531.072 at least once every 12 months and may recommend
inclusions to and exclusions from the lists to ensure that the lists
provide for cost-effective medically appropriate drug therapies
for Medicaid recipients, children receiving health benefits
coverage under the child health plan program, and any other
affected individuals.
(k) The commission shall provide administrative support and
resources as necessary for the committee to perform its duties.
(l) Chapter 2110 does not apply to the committee.
(m) The commission or the commission's agent shall publicly
disclose each specific drug recommended for or against preferred
drug list status for each drug class included in the preferred drug
list for the Medicaid vendor drug program. The disclosure must be
made in writing and posted to the Internet after the conclusion of
committee deliberations that result in recommendations made to the
executive commissioner regarding the placement of drugs on the
preferred drug list. Such public disclosure shall include:
(A) the general basis for each recommendation for or
against placement on the preferred drug list, including a statement
of satisfaction of or failure to meet the criteria listed in
Subsection 531.074(h);
(B) for all recommendations of the committee
supporting placement of a drug on the preferred drug list, a
statement that a supplemental rebate agreement was reached or, in
the absence of a supplemental rebate agreement, a statement noting
which exception described in Section 531.072(b) has been satisfied;
and
(C) for all recommendations of the committee against
placement of a drug on the preferred drug list, a statement of
which of the criterion listed in Subsection 531.074(h) was not
satisfied. If the clinical efficacy or safety criterion were not
satisfied, a summary of the information relied upon by the
committee supporting such conclusion must also be provided.
Sec. 531.075. Publication of Information Relating to
Commission Decision-making. (a) The commission shall publish on
the Internet its decisions on preferred drug list placement
including:
(1) A list of drugs reviewed and its decision for or
against placement on the preferred drug list for each drug;
(2) A statement that a supplemental rebate agreement
was or was not reached between the commission and a manufacturer or
labeler for a particular drug. If a supplemental rebate agreement
was reached, a statement that such agreement was or was not of a
sufficient amount to make the drug cost-effective for preferred
drug list placement, without disclosing the amount of the rebate or
other confidential information described in Section 531.071; and
(3) The rationale for any departure from the
recommendations of the pharmaceutical and therapeutics committee.
If a recommendation was rejected for safety or clinical efficacy
reasons, information supporting such decision shall be disclosed.
SECTION 2. This Act takes effect September 1, 2009.