4 | 3 | | |
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5 | 4 | | SENATE BILL 152 |
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6 | 5 | | By Pody |
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7 | 6 | | |
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8 | 7 | | |
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9 | 8 | | SB0152 |
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10 | 9 | | 000703 |
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11 | 10 | | - 1 - |
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12 | 11 | | |
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13 | 12 | | AN ACT to amend Tennessee Code Annotated, Title 53; |
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14 | 13 | | Title 63 and Title 68, relative to stem cell |
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15 | 14 | | treatment. |
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16 | 15 | | |
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17 | 16 | | BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF TENNESSEE: |
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18 | 17 | | SECTION 1. Tennessee Code Annotated, Title 63, Chapter 6, is amended by adding |
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19 | 18 | | the following as a new part: |
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20 | 19 | | 63-6-901. Part definitions. |
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21 | 20 | | As used in this part: |
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22 | 21 | | (1) "Commissioner" means the commissioner of health; |
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23 | 22 | | (2) "Governmental entity" means this state or an agency or political |
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24 | 23 | | subdivision of this state; |
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25 | 24 | | (3) "Investigational stem cell treatment" means an adult stem cell |
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26 | 25 | | treatment that: |
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27 | 26 | | (A) Is under investigation in a clinical trial and being administered |
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28 | 27 | | to human participants in that trial; and |
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29 | 28 | | (B) Has not yet been approved for general use by the United |
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30 | 29 | | States food and drug administration; |
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31 | 30 | | (4) "Severe chronic disease" means a condition, injury, or illness that: |
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32 | 31 | | (A) May be treated; |
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33 | 32 | | (B) Is never cured or eliminated; and |
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34 | 33 | | (C) Entails significant functional impairment or severe pain; and |
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35 | 34 | | |
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36 | 35 | | |
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37 | 36 | | - 2 - 000703 |
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38 | 37 | | |
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39 | 38 | | (5) "Terminal illness" means an advanced stage of a disease with an |
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40 | 39 | | unfavorable prognosis that, without life-sustaining procedures, will soon result in |
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41 | 40 | | death or a state of permanent unconsciousness from which recovery is unlikely. |
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42 | 41 | | 63-6-902. Patient eligibility. |
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43 | 42 | | A patient may access and use an investigational stem cell treatment under this |
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44 | 43 | | part if: |
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45 | 44 | | (1) The patient has a severe chronic disease or terminal illness listed in |
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46 | 45 | | the rules adopted under § 63-6-907 and attested to by the patient's treating |
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47 | 46 | | physician; and |
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48 | 47 | | (2) The patient's treating physician: |
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49 | 48 | | (A) In consultation with the patient, has considered all other |
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50 | 49 | | treatment options currently approved by the United States food and drug |
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51 | 50 | | administration and determined that those treatment options are |
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52 | 51 | | unavailable or unlikely to alleviate the significant impairment or severe |
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53 | 52 | | pain associated with the severe chronic disease or terminal illness; and |
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54 | 53 | | (B) Has recommended or prescribed in writing that the patient |
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55 | 54 | | use a specific class of investigational stem cell treatment. |
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56 | 55 | | 63-6-903. Informed consent. |
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57 | 56 | | (a) Before receiving an investigational stem cell treatment, an eligible patient |
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58 | 57 | | must sign a written informed consent. |
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59 | 58 | | (b) If the patient is a minor or lacks the mental capacity to provide informed |
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60 | 59 | | consent, then a parent, guardian, or conservator may provide informed consent on the |
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61 | 60 | | patient's behalf. |
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62 | 61 | | (c) The commissioner may develop and make available to physicians a form for |
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63 | 62 | | the informed consent under this section. |
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64 | 63 | | |
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65 | 64 | | |
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66 | 65 | | - 3 - 000703 |
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67 | 66 | | |
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68 | 67 | | 63-6-904. Effect on other law. |
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69 | 68 | | (a) This part does not affect the coverage of enrollees in clinical trials under § |
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70 | 69 | | 56-7-2365. |
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71 | 70 | | (b) This part does not affect or authorize a person to violate any law regulating |
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72 | 71 | | the possession, use, or transfer of fetal tissue, fetal stem cells, adult stem cells, or |
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73 | 72 | | human organs, including § 39-15-208. |
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74 | 73 | | 63-6-905. Action against physician license prohibited. |
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75 | 74 | | Notwithstanding another law, the board of medical examiners and the board of |
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76 | 75 | | osteopathic examination shall not revoke, fail to renew, suspend, or take any action |
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77 | 76 | | against a physician's license based solely on the physician's recommendations to an |
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78 | 77 | | eligible patient regarding access to or use of an investigational stem cell treatment if the |
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79 | 78 | | care provided or recommendations made to the patient meet the standard of care and |
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80 | 79 | | the requirements of this part. |
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81 | 80 | | 63-6-906. Governmental interference prohibited. |
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82 | 81 | | A governmental entity or an officer, employee, or agent of a governmental entity |
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83 | 82 | | shall not interfere with an eligible patient's access to or use of an investigational stem |
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84 | 83 | | cell treatment authorized under this part. |
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85 | 84 | | 63-6-907. Rules. |
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86 | 85 | | The commissioner shall promulgate rules to effectuate this part. The rules must |
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87 | 86 | | include designating the medical conditions that constitute a severe chronic disease or |
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88 | 87 | | terminal illness for purposes of this part. Rules must be promulgated in accordance with |
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89 | 88 | | the Uniform Administrative Procedures Act, compiled in title 4, chapter 5. |
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90 | 89 | | SECTION 2. The headings to sections in this act are for reference purposes only and do |
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91 | 90 | | not constitute a part of the law enacted by this act. However, the Tennessee Code Commission |
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92 | 91 | | is requested to include the headings in any compilation or publication containing this act. |
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93 | 92 | | |
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94 | 93 | | |
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95 | 94 | | - 4 - 000703 |
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96 | 95 | | |
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97 | 96 | | SECTION 3. This act takes effect upon becoming a law, the public welfare requiring it. |
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