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