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A BILL TO BE ENTITLED
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AN ACT
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relating to preferred drug lists, including confidentiality, |
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supplemental rebate, prior authorization, and publication |
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requirements. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Subsections (a) and (c), Section 531.071, |
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Government Code, are amended to read as follows: |
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(a) Notwithstanding any other state law, financial |
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information obtained or maintained by the commission regarding |
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prescription drug rebate negotiations or a supplemental medical |
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assistance or other rebate agreement, including trade secrets, |
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rebate amount, rebate percentage, and manufacturer or labeler |
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pricing, is confidential and not subject to disclosure under |
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Chapter 552. |
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(c) Notwithstanding Subsection (a), the following |
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information is not confidential: |
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(1) general [General]information about the aggregate |
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costs of different classes of drugs; |
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(2) the fact that a supplemental rebate agreement was |
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or was not reached between the commission and a manufacturer or |
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labeler for a particular drug; and |
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(3) the fact that a supplemental rebate agreement for |
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a particular drug was or was not of a sufficient amount to make the |
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drug cost-effective for preferred drug list placement, provided |
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that the amount of the rebate or other confidential financial |
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information described in this section is not disclosed [is not
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confidential under Subsection (a)]. |
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SECTION 2. Section 531.072, Government Code, is amended by |
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amending Subsection (b) and adding Subsections (b-1), (b-2), and |
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(g) to read as follows: |
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(b) The preferred drug lists may contain only drugs provided |
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by a manufacturer or labeler that reaches an agreement with the |
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commission on supplemental rebates under Section 531.070 unless one |
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of the following exceptions is met: |
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(1) the commission determines that the drug provided |
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by a generic manufacturer or labeler without a supplemental rebate |
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is as cost-effective as or more cost-effective than a drug provided |
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by a brand name manufacturer or labeler who has reached a |
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supplemental rebate agreement with the commission in the same drug |
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class; or |
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(2) a program benefit agreement as described in |
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Section 531.070 has been reached by the commission and a labeler or |
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manufacturer. |
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(b-1) A placement of a drug on the preferred drug list must |
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include all strengths and dosages. |
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(b-2) Each drug class must include multiple methods of |
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delivery of the drug, including liquid, tablet, capsule, and orally |
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disintegrating tablet. |
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(g) Beginning one year after the last review of the drug or |
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its drug class, a generic manufacturer or labeler may make an |
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application or request to have its drug reconsidered for preferred |
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drug placement based upon satisfaction of the cost-effectiveness |
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exception described by Subsection (b)(1). |
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SECTION 3. Section 531.073, Government Code, is amended by |
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adding Subsection (g) to read as follows: |
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(g) The commission shall ensure that prior authorization |
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claims submission may occur through multiple telecommunication |
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modes, including electronic point-of-sale submission, telephonic |
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submission, fax submission, and electronic communications via the |
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Internet. |
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SECTION 4. Subsections (i) and (m), Section 531.074, |
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Government Code, are amended to read as follows: |
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(i) The commission shall adopt rules governing the |
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operation of the committee, including rules: |
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(1) governing the procedures used by the committee for |
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providing notice of a meeting; [and] |
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(2) [rules] prohibiting the committee from discussing |
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confidential financial information described by Section 531.071 in |
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a public meeting; and |
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(3) requiring the committee or its delegate to present |
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in oral and written form, at the public meeting, a summary of any |
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clinical efficacy and safety information or analyses provided to |
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the committee by a private entity that has contracted with the |
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commission to provide such information. Confidential financial |
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information described in Section 531.071 shall be omitted from the |
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summary. The written summary shall be posted to the Internet. [The
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committee shall comply with the rules adopted under this
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subsection.] |
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(m) The commission or the commission's agent shall publicly |
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disclose, for each specific drug, a recommendation [recommended] |
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for or against preferred drug list status, for each drug class |
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included in the preferred drug list for the Medicaid vendor drug |
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program. The disclosure must be made in writing and posted to the |
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Internet after the conclusion of committee deliberations that |
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result in recommendations made to the executive commissioner |
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regarding the placement of drugs on the preferred drug list. Such |
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public disclosure shall include: |
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(1) the general basis for each recommendation for or |
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against placement on the preferred drug list, including a statement |
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of satisfaction of or failure to meet the criteria listed in |
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Subsection (h); |
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(2) for all recommendations of the committee |
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supporting placement of a drug on the preferred drug list, a |
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statement that a supplemental rebate agreement was reached or, in |
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the absence of a supplemental rebate agreement, a statement noting |
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which exception described in Section 531.072(b) has been satisfied; |
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and |
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(3) for all recommendations of the committee against |
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placement of a drug on the preferred drug list, a statement of which |
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of the criteria listed in Subsection (h) were not satisfied and, if |
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the clinical efficacy or safety criterion was not satisfied, a |
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summary of the information relied upon by the committee supporting |
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such conclusion. |
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SECTION 5. Subchapter B, Chapter 531, Government Code, is |
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amended by adding Section 531.0741 to read as follows: |
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Sec. 531.0741. PUBLICATION OF INFORMATION RELATING TO |
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COMMISSION DECISION-MAKING. The commission shall publish on the |
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Internet its decisions on preferred drug list placement including: |
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(1) a list of drugs reviewed and the commission's |
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decision for or against placement on the preferred drug list for |
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each drug; |
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(2) a statement that a supplemental rebate agreement |
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was or was not reached between the commission and a manufacturer or |
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labeler for a particular drug and, if a supplemental rebate |
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agreement was reached, a statement that such agreement was or was |
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not of a sufficient amount to make the drug cost-effective for |
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preferred drug list placement, without disclosing the amount of the |
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rebate or other confidential information described in Section |
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531.071; and |
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(3) the rationale for any departure from the |
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recommendations of the Pharmaceutical and Therapeutics Committee |
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and, if a recommendation was rejected for safety or clinical |
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efficacy reasons, information supporting such a decision. |
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SECTION 6. This Act takes effect September 1, 2009. |