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A BILL TO BE ENTITLED
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AN ACT
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relating to the establishment of a program to provide prescribers |
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with evidence-based information about pharmaceuticals; assessing a |
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fee; providing penalties. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. It is the intent of the legislature to ensure |
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that health care professionals have balanced and unbiased |
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evidence-based information readily available in order to ensure the |
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highest quality prescribing decisions are made for the citizens of |
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this state, which will improve health outcomes and reduce |
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unnecessary costs. |
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SECTION 2. Chapter 531, Government Code, is amended by |
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adding Subchapter Q to read as follows: |
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SUBCHAPTER Q. EVIDENCE-BASED PRESCRIBER EDUCATION SERVICE |
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Sec. 531.651. DEFINITIONS. In this subchapter: |
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(1) "Prescribed product" includes a drug or device as |
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defined in Section 201 of the Federal Food, Drug, and Cosmetic Act |
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(21 U.S.C. Section 321) and a biological product as defined in |
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Section 351 of the Public Health Service Act (42 U.S.C. Section |
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262). |
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(2) "State health care program" means a program for |
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which the state purchases prescribed products, including the state |
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Medicaid program, a state pharmaceutical assistance program, or a |
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program for state employees and their dependents, individuals under |
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the supervision of corrections, or state retirees and their |
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dependents. |
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Sec. 531.652. ESTABLISHMENT OF EDUCATION SERVICE. (a) The |
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executive commissioner, in collaboration with an institution of |
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higher education in this state, shall develop an evidence-based |
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prescription education service designed to provide health care |
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professionals who are licensed to prescribe or dispense prescribed |
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products with information and education from a noncommercial source |
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on the comparative efficacy, safety, and cost-effectiveness of |
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commonly used prescribed products. |
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(b) In designing the service, the executive commissioner |
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shall consult with appropriate health care professionals or |
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organizations knowledgeable about the practice of medicine and |
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continuing medical education. |
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(c) The education service shall be geared toward assisting |
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health care professionals who are licensed to prescribe or dispense |
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prescribed products with making appropriate pharmaceutical |
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recommendations. |
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Sec. 531.653. REQUIREMENTS FOR EDUCATION SERVICE. (a) The |
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education service established by the executive commissioner under |
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Section 531.652 shall conduct in-person outreach and education |
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sessions that are: |
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(1) made available to health care professionals who |
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participate in, contract with, or are reimbursed by state-funded |
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health care programs; |
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(2) made available to health care professionals in |
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their place of work; |
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(3) facilitated by qualified and appropriately |
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trained clinician-educators; and |
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(4) conducted on a one-to-one basis, whenever |
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practicable. |
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(b) The service may also provide education to other health |
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care professionals as funding permits or for a fee. |
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(c) The educational materials used by the education service |
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must be based on a balanced, clinically relevant, and comprehensive |
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review of evidence that is accepted within the practice of |
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medicine, including scientific research that conforms to the |
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generally accepted standards of experimental design, data |
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collection, analysis, and interpretation with the purpose of |
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providing unbiased and objective continuing education on the |
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comparative efficacy, safety, and cost-effectiveness of |
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medications. |
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(d) The education service may use materials developed by a |
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medical school, an academic medical center, a school of pharmacy, a |
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medical society, a research institute, or another publicly |
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sponsored prescriber education service. |
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Sec. 531.654. RULES OF EDUCATION SERVICE. (a) The |
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executive commissioner shall adopt the rules necessary to implement |
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this subchapter. |
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(b) The rules adopted under this subchapter must establish: |
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(1) minimum clinical and educational qualifications |
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for prescriber educators employed by or under contract with the |
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education service; |
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(2) required training for educators; |
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(3) a code of conduct governing the behavior of |
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educators in their interactions with health care professionals; and |
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(4) conflict of interest guidelines for educators and |
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others involved in advising, developing, and administering the |
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service. |
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Sec. 531.655. FEE. (a) Each wholesale distributor of |
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prescription drugs that is licensed under Subchapter N, Chapter |
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431, Health and Safety Code, that employs, directs, or utilizes one |
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or more prescription marketing representatives in this state to |
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market the distributor's prescription drugs shall pay to the |
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commission an annual fee in the amount of $2,500. |
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(b) The fee collected by the commission under this section |
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shall be deposited to the credit of the general revenue fund and may |
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be appropriated only for the education service established under |
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this subchapter. |
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(c) A wholesale distributor that fails to pay the fee |
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required by this section is subject to disciplinary action by the |
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Department of State Health Services under Section 431.414, Health |
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and Safety Code, as if the distributor violated Subchapter N, |
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Chapter 431, Health and Safety Code. |
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Sec. 531.656. COMMISSION DUTIES. The commission shall seek |
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and take all necessary actions to receive federal financial |
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participation for any academic detailing provided through the state |
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Medicaid program at the administrative matching rate of 50 percent. |
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Sec. 531.657. GIFTS AND GRANTS. The executive commissioner |
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may seek grants and financial gifts from nonprofit charitable |
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foundations to cover planning, development, and the ongoing |
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operation of the education service provided under this subchapter. |
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Sec. 531.658. REPORT. The executive commissioner shall |
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present an annual report on the development of the education |
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service to: |
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(1) the presiding officer of each house of the |
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legislature; and |
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(2) the chair of each committee in the legislature |
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with primary jurisdiction over the commission. |
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SECTION 3. (a) Not later than January 1, 2010, the |
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executive commissioner shall adopt the rules required by Subchapter |
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Q, Chapter 531, Government Code, as added by this Act. |
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(b) Not later than September 1, 2010, the executive |
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commissioner, in collaboration with an institution of higher |
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education in this state, shall establish the education service as |
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required by Subchapter Q, Chapter 531, Government Code, as added by |
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this Act. |
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(c) Notwithstanding Subchapter Q, Chapter 531, Government |
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Code, as added by this Act, a wholesale distributor is not required |
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to pay the fee required under Subchapter Q until January 1, 2010. |
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SECTION 4. This Act takes effect September 1, 2009. |