2009S0595-1 03/06/09
By: Uresti S.B. No. 1536
A BILL TO BE ENTITLED
AN ACT
relating to preferred drug lists, including confidentiality,
supplemental rebate, prior authorization, and publication
requirements.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subsections (a) and (c), Section 531.071,
Government Code, are amended to read as follows:
(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.
(c) Notwithstanding Subsection (a), the following
information is not confidential:
(1) general [General]information about the aggregate
costs of different classes of drugs;
(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, provided
that the amount of the rebate or other confidential financial
information described in this section is not disclosed [is not
confidential under Subsection (a)].
SECTION 2. Section 531.072, Government Code, is amended by
amending Subsection (b) and adding Subsections (b-1), (b-2), and
(g) to read as follows:
(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 cost-effective 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; or
(2) a program benefit agreement as described in
Section 531.070 has been reached by the commission and a labeler or
manufacturer.
(b-1) A placement of a drug on the preferred drug list must
include all strengths and dosages.
(b-2) Each drug class must include multiple methods of
delivery of the drug, including liquid, tablet, capsule, and orally
disintegrating tablet.
(g) Beginning one year after 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 by Subsection (b)(1).
SECTION 3. Section 531.073, Government Code, is amended by
adding Subsection (g) to read as follows:
(g) The commission shall ensure that prior authorization
claims submission may occur through multiple telecommunication
modes, including electronic point-of-sale submission, telephonic
submission, fax submission, and electronic communications via the
Internet.
SECTION 4. Subsections (i) and (m), Section 531.074,
Government Code, are amended to read as follows:
(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
(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. [The
committee shall comply with the rules adopted under this
subsection.]
(m) The commission or the commission's agent shall publicly
disclose, for each specific drug, a recommendation [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:
(1) 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 (h);
(2) 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
(3) for all recommendations of the committee against
placement of a drug on the preferred drug list, a statement of which
of the criteria listed in Subsection (h) were not satisfied and, if
the clinical efficacy or safety criterion was not satisfied, a
summary of the information relied upon by the committee supporting
such conclusion.
SECTION 5. Subchapter B, Chapter 531, Government Code, is
amended by adding Section 531.0741 to read as follows:
Sec. 531.0741. PUBLICATION OF INFORMATION RELATING TO
COMMISSION DECISION-MAKING. The commission shall publish on the
Internet its decisions on preferred drug list placement including:
(1) a list of drugs reviewed and the commission's
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 and, 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
and, if a recommendation was rejected for safety or clinical
efficacy reasons, information supporting such a decision.
SECTION 6. This Act takes effect September 1, 2009.