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5 | 5 | | 2023 -- H 5877 |
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6 | 6 | | ======== |
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7 | 7 | | LC001692 |
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8 | 8 | | ======== |
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9 | 9 | | S TATE OF RHODE IS LAND |
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10 | 10 | | IN GENERAL ASSEMBLY |
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11 | 11 | | JANUARY SESSION, A.D. 2023 |
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12 | 12 | | ____________ |
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13 | 13 | | |
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14 | 14 | | A N A C T |
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15 | 15 | | RELATING TO HEALTH AND SAFETY -- MEDICAL SPAS SAFETY ACT |
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16 | 16 | | Introduced By: Representatives Baginski, and Casey |
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17 | 17 | | Date Introduced: March 01, 2023 |
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18 | 18 | | Referred To: House Health & Human Services |
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19 | 19 | | |
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20 | 20 | | |
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21 | 21 | | It is enacted by the General Assembly as follows: |
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22 | 22 | | SECTION 1. Title 23 of the General Laws entitled "HEALTH AND SAFETY" is hereby 1 |
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23 | 23 | | amended by adding thereto the following chapter: 2 |
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24 | 24 | | CHAPTER 99 3 |
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25 | 25 | | MEDICAL SPAS SAFETY ACT 4 |
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26 | 26 | | 23-99-1. Definitions. 5 |
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27 | 27 | | For purposes of this chapter: 6 |
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28 | 28 | | (1) "Ablative lasers or ablative energy devices" means lasers intended to excise or vaporize 7 |
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29 | 29 | | the outer layer of skin. 8 |
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30 | 30 | | (2) "Advanced practice registered nurse" or "APRN" means a registered nurse who has an 9 |
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31 | 31 | | active, unrestricted advanced practice registered nurse license granted under the authority of 10 |
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32 | 32 | | chapter 34 of title 5. 11 |
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33 | 33 | | (3) "Cosmetic medical procedure" means any procedure that does not require sedation that 12 |
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34 | 34 | | is performed on a person and is directed at improving the person's appearance and does not 13 |
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35 | 35 | | meaningfully promote the proper function of the body or prevent or treat illness or disease. 14 |
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36 | 36 | | Cosmetic medical procedures may include, but are not limited to, cosmetic surgery, microneedling, 15 |
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37 | 37 | | hair transplants, cosmetic injections, cosmetic soft tissue fillers, dermaplaning, dermastamping, 16 |
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38 | 38 | | dermarolling, dermabrasion that removes cells beyond the stratum corneum, chemical peels using 17 |
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39 | 39 | | modification solutions that exceed thirty percent (30%) concentration with a pH value of lower 18 |
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40 | 40 | | than 3.0, laser hair removal, laser restricting, laser treatment of veins, sclerotherapy, other laser 19 |
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41 | 41 | | |
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42 | 42 | | |
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43 | 43 | | LC001692 - Page 2 of 14 |
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44 | 44 | | procedures, intense pulsed light, injection of cosmetic filling agents and neurotoxins and the use of 1 |
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45 | 45 | | class II medical devices designed to induce deep skin tissue alteration. The performance of cosmetic 2 |
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46 | 46 | | medical services is the practice of medicine and surgery. A cosmetic medical service shall be 3 |
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47 | 47 | | performed by a qualified licensed or certified non-physician only if the services have been 4 |
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48 | 48 | | delegated by a medical director, supervising physician, supervising PA, or supervising APRN who 5 |
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49 | 49 | | is responsible for on-site supervision of the services performed. 6 |
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50 | 50 | | (4) "Delegate" means a non-physician tasked with performing a procedure as defined in § 7 |
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51 | 51 | | 23-99-1 by a physician, PA or APRN. 8 |
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52 | 52 | | (5) "Department" means the Rhode Island department of health. 9 |
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53 | 53 | | (6) "Medical director" means a physician or advanced practice registered nurse who 10 |
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54 | 54 | | assumes the role of, or holds oneself out as, medical director at a medical spa. The medical director 11 |
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55 | 55 | | shall be: 12 |
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56 | 56 | | (i) Trained in the indications for, and performance of, cosmetic medical procedures, 13 |
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57 | 57 | | including all medical devices or instruments that can alter or cause biological change or damage 14 |
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58 | 58 | | the skin and subcutaneous tissue. Training programs provided by a manufacturer or vendor of a 15 |
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59 | 59 | | medical device or supplies shall not be a medical director's, supervising physician's, PA's or 16 |
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60 | 60 | | APRN's only education in the cosmetic medical service or the operation of medical devices to be 17 |
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61 | 61 | | used; 18 |
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62 | 62 | | (ii) Responsible for implementing policies and procedures to ensure quality patient care; 19 |
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63 | 63 | | (iii) Responsible for the delegation and supervision of cosmetic procedures; 20 |
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64 | 64 | | (iv) Responsible for the oversight of all cosmetic medical procedures performed by 21 |
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65 | 65 | | physicians, PAs, APRNs, and non-physicians; and 22 |
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66 | 66 | | (v) Responsible for ensuring that all supervising physicians, supervising PAs and 23 |
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67 | 67 | | supervising APRNs, any physicians, PAs and APRNs performing cosmetic medical procedures, 24 |
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68 | 68 | | and any non-physicians, non-PAs and non-APRNs delegated to perform cosmetic medical 25 |
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69 | 69 | | procedures, are properly trained in the safe and effective performance of all cosmetic medical 26 |
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70 | 70 | | procedures that they perform at the medical spa. 27 |
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71 | 71 | | (7) "Medical spa" means an establishment in which cosmetic medical procedures are 28 |
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72 | 72 | | performed. 29 |
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73 | 73 | | (8) "Physician" means an allopath or osteopath who has an active license, unrestricted 30 |
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74 | 74 | | medical license granted under the provisions of chapter 37 of title 5. 31 |
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75 | 75 | | (9) "Physician assistant" or "PA" means a person who is qualified by academic and 32 |
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76 | 76 | | practical training to provide medical and surgical services in collaboration with physicians. 33 |
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77 | 77 | | (10) "Supervision" means an arrangement when a qualified supervising physician, 34 |
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78 | 78 | | |
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79 | 79 | | |
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80 | 80 | | LC001692 - Page 3 of 14 |
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81 | 81 | | physician assistant or APRN is either: 1 |
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82 | 82 | | (i) On site and able to directly observe the treatment being performed, though not 2 |
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83 | 83 | | necessarily in the same room (i.e., direct supervision); or 3 |
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84 | 84 | | (ii) Is off site, but immediately available if needed, either in person or by 4 |
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85 | 85 | | telecommunication (i.e., indirect supervision). 5 |
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86 | 86 | | 23-99-2. Protection of patients in a medical spa. 6 |
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87 | 87 | | (a) Each medical spa shall appoint a medical director who shall be: 7 |
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88 | 88 | | (1) Trained in the indications for, and performance of, cosmetic medical procedures, 8 |
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89 | 89 | | including all medical devices or instruments that can alter or cause biological change or damage to 9 |
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90 | 90 | | the skin or subcutaneous tissue. Training programs provided by a manufacturer or vendor of a 10 |
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91 | 91 | | medical device or supplies shall not be a medical director's, supervising physician's, supervising 11 |
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92 | 92 | | PA's or APRN's only education in the cosmetic medical service or the operation of medical devices 12 |
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93 | 93 | | to be used; 13 |
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94 | 94 | | (2) Responsible for implementing policies and procedures to ensure quality patient care; 14 |
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95 | 95 | | (3) Responsible for the delegation and supervision of cosmetic procedures; 15 |
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96 | 96 | | (4) Responsible for developing and maintaining written office protocols for each cosmetic 16 |
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97 | 97 | | medical procedure. Such protocols shall be kept on site at the medical spa for review and/or 17 |
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98 | 98 | | inspection by the department; 18 |
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99 | 99 | | (5) Responsible for the oversight of all cosmetic medical procedures performed by 19 |
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100 | 100 | | physicians, PAs, APRNs, and non-physicians; and 20 |
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101 | 101 | | (6) Responsible for ensuring that all supervisory physicians, supervising PAs and 21 |
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102 | 102 | | supervising APRNs, any physicians, PAs and APRNs performing cosmetic medical procedures, 22 |
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103 | 103 | | and any non-physicians and non-APRNs delegated to perform cosmetic medical procedures, are 23 |
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104 | 104 | | properly trained in the safe and effective performance of all cosmetic medical procedures that they 24 |
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105 | 105 | | perform at the medical spa. 25 |
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106 | 106 | | (b) A physician, PA or APRN who performs cosmetic medical procedures, or supervises 26 |
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107 | 107 | | such procedures delegated to and performed by a non-physician, non-PA or non-APRN, shall be 27 |
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108 | 108 | | trained in the indications for and performance of the cosmetic medical procedure. An APRN who 28 |
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109 | 109 | | performs cosmetic medical procedures, or supervises such procedures delegated to and performed 29 |
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110 | 110 | | by a non-physician, non-PA or non-APRN, shall be accredited by the state board of nursing. 30 |
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111 | 111 | | (c) The supervising physician, PA or APRN shall: 31 |
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112 | 112 | | (1) Perform an initial assessment of the patient; 32 |
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113 | 113 | | (2) Prepare a written treatment plan for each patient, which plan shall include, as 33 |
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114 | 114 | | applicable, diagnoses, course of treatment, and specifications for any device being used; 34 |
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115 | 115 | | |
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116 | 116 | | |
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117 | 117 | | LC001692 - Page 4 of 14 |
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118 | 118 | | (3) Obtain patient consent, if the cosmetic medical procedure(s) are being performed by a 1 |
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119 | 119 | | non-physician, non-PA or non-APRN and documenting, in the patient’s medical record, the 2 |
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120 | 120 | | credentials and names of the non-physician, non-PA or non-APRN who will be performing the 3 |
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121 | 121 | | cosmetic medical procedure; and 4 |
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122 | 122 | | (4) Create and maintain medical records in a manner consistent with applicable laws and 5 |
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123 | 123 | | regulations and accepted medical practice. 6 |
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124 | 124 | | (d) Non-physicians, non-PAs and non-APRNs shall only perform cosmetic medical 7 |
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125 | 125 | | procedures: 8 |
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126 | 126 | | (1) For which they have the requisite training; and 9 |
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127 | 127 | | (2) Which have been delegated to them by a supervising physician, supervising PA or 10 |
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128 | 128 | | supervising APRN. 11 |
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129 | 129 | | (e) At all times in the performance of their duties relative to cosmetic procedures, all 12 |
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130 | 130 | | providers shall: 13 |
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131 | 131 | | (1) Review and follow written protocols for each delegated cosmetic medical procedure; 14 |
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132 | 132 | | (2) Verify that the supervising physician, supervising PA or supervising APRN has 15 |
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133 | 133 | | assessed the patient and given written treatment instructions for each procedure performed; 16 |
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134 | 134 | | (3) Review the cosmetic medical procedure with each patient; 17 |
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135 | 135 | | (4) Notify the medical director, as well as the supervising physician, supervising PA or 18 |
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136 | 136 | | supervising APRN, before the patient leaves or as they become aware, of any adverse events or 19 |
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137 | 137 | | complications, and follow up with the patient post-procedure, as appropriate; 20 |
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138 | 138 | | (5) Document all relevant details of the performed cosmetic medical procedure in the 21 |
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139 | 139 | | patient’s medical record; and 22 |
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140 | 140 | | (6) As applicable, satisfy any requirements imposed upon them by their licensing boards. 23 |
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141 | 141 | | (f) Cosmetic medical procedures using ablative lasers or ablative energy devices shall only 24 |
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142 | 142 | | be performed by physicians. 25 |
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143 | 143 | | 23-99-3. Rules and regulations. 26 |
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144 | 144 | | The department shall, by July 1, 2024, promulgate rules and regulations necessary and not 27 |
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145 | 145 | | inconsistent with law to implement the purpose and intent of this chapter, which rules and 28 |
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146 | 146 | | regulations shall provide for, though not be limited to, the licensing of medical spas as health care 29 |
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147 | 147 | | facilities. 30 |
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148 | 148 | | SECTION 2. Section 23-17-2 of the General Laws in Chapter 23-17 entitled "Licensing of 31 |
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149 | 149 | | Healthcare Facilities" is hereby amended to read as follows: 32 |
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150 | 150 | | 23-17-2. Definitions. 33 |
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151 | 151 | | As used in this chapter: 34 |
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152 | 152 | | |
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153 | 153 | | |
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154 | 154 | | LC001692 - Page 5 of 14 |
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155 | 155 | | (1) “Affiliate” means a legal entity that is in control of, is controlled by, or is in common 1 |
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156 | 156 | | control with another legal entity. 2 |
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157 | 157 | | (2) “Alzheimer’s dementia special-care unit or program” means a distinct living 3 |
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158 | 158 | | environment within a nursing facility that has been physically adapted to accommodate the 4 |
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159 | 159 | | particular needs and behaviors of those with dementia. The unit provides increased staffing; 5 |
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160 | 160 | | therapeutic activities designed specifically for those with dementia; and trains its staff on an 6 |
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161 | 161 | | ongoing basis on the effective management of the physical and behavioral problems of those with 7 |
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162 | 162 | | dementia. The residents of the unit/program have had a standard, medical-diagnostic evaluation 8 |
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163 | 163 | | and have been determined to have a diagnosis of Alzheimer’s dementia or another dementia. 9 |
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164 | 164 | | (3) “Certified nurse-teacher” means those personnel certified by the department of 10 |
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165 | 165 | | elementary and secondary education and employed pursuant to the provisions of §§ 16-21-7 and 11 |
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166 | 166 | | 16-21-8. 12 |
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167 | 167 | | (4)(i) “Change in operator” means a transfer by the governing body or operator of a 13 |
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168 | 168 | | healthcare facility to any other person (excluding delegations of authority to the medical or 14 |
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169 | 169 | | administrative staff of the facility) of the governing body’s authority to: 15 |
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170 | 170 | | (A) Hire or fire the chief executive officer of the healthcare facility; 16 |
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171 | 171 | | (B) Maintain and control the books and records of the healthcare facility; 17 |
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172 | 172 | | (C) Dispose of assets and incur liabilities on behalf of the healthcare facility; or 18 |
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173 | 173 | | (D) Adopt and enforce policies regarding operation of the healthcare facility. 19 |
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174 | 174 | | (ii) This definition is not applicable to circumstances wherein the governing body of a 20 |
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175 | 175 | | healthcare facility retains the immediate authority and jurisdiction over the activities enumerated 21 |
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176 | 176 | | in subsections (4)(i)(A) — (4)(i)(D). 22 |
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177 | 177 | | (5) “Change in owner” means: 23 |
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178 | 178 | | (i) In the case of a healthcare facility that is a partnership, the removal, addition, or 24 |
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179 | 179 | | substitution of a partner that results in a new partner acquiring a controlling interest in the 25 |
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180 | 180 | | partnership; 26 |
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181 | 181 | | (ii) In the case of a healthcare facility that is an unincorporated, solo proprietorship, the 27 |
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182 | 182 | | transfer of the title and property to another person; 28 |
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183 | 183 | | (iii) In the case of a healthcare facility that is a corporation: 29 |
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184 | 184 | | (A) A sale, lease exchange, or other disposition of all, or substantially all, of the property 30 |
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185 | 185 | | and assets of the corporation; or 31 |
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186 | 186 | | (B) A merger of the corporation into another corporation; or 32 |
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187 | 187 | | (C) The consolidation or two (2) or more corporations, resulting in the creation of a new 33 |
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188 | 188 | | corporation; or 34 |
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189 | 189 | | |
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190 | 190 | | |
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191 | 191 | | LC001692 - Page 6 of 14 |
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192 | 192 | | (D) In the case of a healthcare facility that is a business corporation, any transfer of 1 |
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193 | 193 | | corporate stock that results in a new person acquiring a controlling interest in the corporation; or 2 |
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194 | 194 | | (E) In the case of a healthcare facility that is a nonbusiness corporation, any change in 3 |
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195 | 195 | | membership that results in a new person acquiring a controlling vote in the corporation. 4 |
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196 | 196 | | (6) “Clinician” means a physician licensed under chapter 37 of title 5; a nurse licensed 5 |
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197 | 197 | | under chapter 34 of title 5; a psychologist licensed under chapter 44 of title 5; a social worker 6 |
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198 | 198 | | licensed under chapter 39.1 of title 5; a physical therapist licensed under chapter 40 of title 5; and 7 |
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199 | 199 | | a speech language pathologist or audiologist licensed under chapter 48 of title 5 or physician 8 |
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200 | 200 | | assistant licensed under the provisions of chapter 54 of title 5. 9 |
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201 | 201 | | (7) “Director” means the director of the Rhode Island state department of health. 10 |
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202 | 202 | | (8) “Freestanding emergency-care facility” means an establishment, place, or facility that 11 |
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203 | 203 | | may be a public or private organization, structurally distinct and separate from a hospital; staffed, 12 |
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204 | 204 | | equipped, and operated to provide prompt, emergency medical care. For the purposes of this 13 |
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205 | 205 | | chapter, “emergency medical care” means services provided for a medical condition or behavioral-14 |
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206 | 206 | | health condition that is manifested by symptoms of sufficient severity that, in the absence of 15 |
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207 | 207 | | immediate medical attention, could result in harm to the person or others; serious impairment to 16 |
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208 | 208 | | bodily functions; serious dysfunction of any bodily organ or part; or development or continuance 17 |
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209 | 209 | | of severe pain. 18 |
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210 | 210 | | (9) “Healthcare facility” means any institutional health-service provider, facility, or 19 |
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211 | 211 | | institution, place, building, agency, or portion thereof, whether a partnership or corporation, 20 |
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212 | 212 | | whether public or private, whether organized for profit or not, used, operated, or engaged in 21 |
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213 | 213 | | providing healthcare services, including, but not limited to: hospitals; nursing facilities; home 22 |
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214 | 214 | | nursing-care provider (which shall include skilled nursing services and may also include activities 23 |
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215 | 215 | | allowed as a home-care provider or as a nursing service agency); home-care provider (which may 24 |
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216 | 216 | | include services such as personal care or homemaker services); rehabilitation centers; kidney 25 |
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217 | 217 | | disease treatment centers; health maintenance organizations; freestanding emergency-care facilities 26 |
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218 | 218 | | as defined in this section, and facilities providing surgical treatment to patients not requiring 27 |
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219 | 219 | | hospitalization (surgi-centers); hospice care, and physician ambulatory-surgery centers and 28 |
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220 | 220 | | podiatry ambulatory-surgery centers providing surgical treatment. The term “healthcare facility” 29 |
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221 | 221 | | also includes organized ambulatory-care facilities that are not part of a hospital but that are 30 |
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222 | 222 | | organized and operated to provide healthcare services to outpatients, such as: central-services 31 |
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223 | 223 | | facilities serving more than one healthcare facility or healthcare provider; treatment centers; 32 |
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224 | 224 | | diagnostic centers; outpatient clinics; medical spas as defined in chapter 99 of title 23; infirmaries 33 |
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225 | 225 | | and health centers; school-based health centers, and neighborhood health centers. The term 34 |
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226 | 226 | | |
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227 | 227 | | |
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228 | 228 | | LC001692 - Page 7 of 14 |
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229 | 229 | | “healthcare facility” also includes a mobile health-screening vehicle as defined in this section. The 1 |
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230 | 230 | | term “healthcare facility” shall not apply to organized, ambulatory-care facilities owned and 2 |
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231 | 231 | | operated by professional service corporations as defined in chapter 5.1 of title 7, as amended (the 3 |
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232 | 232 | | “professional service corporation law”), or to a practitioner’s (physician, dentist, or other healthcare 4 |
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233 | 233 | | provider) office or group of practitioners’ offices (whether owned and/or operated by a hospital or 5 |
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234 | 234 | | an affiliate of a hospital or an individual practitioner, alone or as a member of a partnership, 6 |
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235 | 235 | | professional service corporation, organization, or association); provided, however, notwithstanding 7 |
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236 | 236 | | any other provision herein or in the general laws, any hospital or any affiliate of a hospital that 8 |
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237 | 237 | | owns and/or operates a practitioner’s office shall ensure that such practitioner’s office complies 9 |
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238 | 238 | | with licensing or accreditation requirements that may be applicable to the practitioner’s office. 10 |
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239 | 239 | | Individual categories of healthcare facilities shall be defined in rules and regulations promulgated 11 |
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240 | 240 | | by the licensing agency with the advice of the health services council. Rules and regulations 12 |
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241 | 241 | | concerning hospice care shall be promulgated with regard to the “Standards of a Hospice Program 13 |
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242 | 242 | | of Care,” promulgated by the National Hospice Organization. Any provider of hospice care who 14 |
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243 | 243 | | provides hospice care without charge shall be exempt from the licensing provisions of this chapter 15 |
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244 | 244 | | but shall meet the “Standards of a Hospice Program of Care.” Facilities licensed by the department 16 |
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245 | 245 | | of behavioral healthcare, developmental disabilities and hospitals and the department of human 17 |
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246 | 246 | | services, and clinical laboratories licensed in accordance with chapter 16.2 of this title, as well as 18 |
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247 | 247 | | Christian Science institutions (also known as Christian Science Nursing Facilities) listed and 19 |
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248 | 248 | | certified by the Commission for Accreditation of Christian Science Nursing 20 |
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249 | 249 | | Organizations/Facilities, Inc. shall not be considered healthcare facilities for purposes of this 21 |
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250 | 250 | | chapter. 22 |
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251 | 251 | | (10) “Homemaker,” or however else called, means a trained, nonprofessional worker who 23 |
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252 | 252 | | performs related housekeeping services in the home for the sick, disabled, dependent, or infirm, 24 |
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253 | 253 | | and as further defined by regulation; the director shall establish criteria for training. 25 |
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254 | 254 | | (11) “Hospital” means a person or governmental entity licensed in accordance with this 26 |
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255 | 255 | | chapter to establish, maintain, and operate a hospital. 27 |
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256 | 256 | | (12) “Licensing agency” means the Rhode Island state department of health. 28 |
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257 | 257 | | (13) “Medical services” means any professional services and supplies rendered by, or under 29 |
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258 | 258 | | the direction of, persons duly licensed under the laws of this state to practice medicine, surgery, or 30 |
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259 | 259 | | podiatry that may be specified by any medical service plan. Medical service shall not be construed 31 |
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260 | 260 | | to include hospital services. 32 |
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261 | 261 | | (14) “Mobile health-screening vehicle” means a mobile vehicle, van, or trailer that delivers 33 |
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262 | 262 | | primary and preventive healthcare screening services, and: 34 |
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263 | 263 | | |
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264 | 264 | | |
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265 | 265 | | LC001692 - Page 8 of 14 |
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266 | 266 | | (i) Does not maintain active contracts or arrangements with any health insurer subject to 1 |
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267 | 267 | | regulation under chapter 20 or 42 of title 27; 2 |
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268 | 268 | | (ii) Does not maintain active contracts or arrangements with another licensed healthcare 3 |
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269 | 269 | | facility as that term is defined within this section; and 4 |
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270 | 270 | | (iii) Does not provide medical services free of charge. 5 |
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271 | 271 | | (15) “Non-English speaker” means a person who cannot speak or understand, or has 6 |
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272 | 272 | | difficulty in speaking or understanding, the English language, because he/she uses only, or 7 |
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273 | 273 | | primarily, a spoken language other than English, and/or a person who uses a sign language and 8 |
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274 | 274 | | requires the use of a sign-language interpreter to facilitate communication. 9 |
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275 | 275 | | (16) “Person” means any individual, trust or estate, partnership, corporation (including 10 |
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276 | 276 | | associations, joint stock companies, and insurance companies), state, or political subdivision or 11 |
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277 | 277 | | instrumentality of a state. 12 |
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278 | 278 | | (17) “Physician ambulatory-surgery center” means an office, or portion of an office, that 13 |
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279 | 279 | | is utilized for the purpose of furnishing surgical services to the owner and/or operator’s own 14 |
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280 | 280 | | patients on an ambulatory basis, and shall include both single-practice, physician ambulatory-15 |
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281 | 281 | | surgery centers and multi-practice, physician ambulatory-surgery centers. A “single-practice, 16 |
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282 | 282 | | physician ambulatory-surgery center” is a physician ambulatory center owned and/or operated by 17 |
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283 | 283 | | a physician-controlled professional service corporation as defined in chapter 5.1 of title 7 (the 18 |
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284 | 284 | | “professional service corporation law”), or a physician-controlled limited-liability company (as 19 |
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285 | 285 | | defined in chapter 16 of title 7 (the “limited liability company act”)) in which no physician is an 20 |
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286 | 286 | | officer, shareholder, director, or employee of any other corporation engaged in the practice of the 21 |
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287 | 287 | | same profession, or a private physician’s office (whether owned and/or operated by an individual 22 |
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288 | 288 | | practitioner, alone or as a member of a partnership, professional service corporation, limited-23 |
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289 | 289 | | liability company, organization, or association). A “multi-practice, physician ambulatory-surgery 24 |
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290 | 290 | | center” is a physician ambulatory-surgery center owned and/or operated by a physician-controlled 25 |
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291 | 291 | | professional service corporation (as defined in the professional service corporation law) or a 26 |
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292 | 292 | | physician-controlled limited-liability company (as defined in the limited liability company act) in 27 |
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293 | 293 | | which a physician is also an officer, shareholder, director, or employee of another corporation 28 |
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294 | 294 | | engaged in the practice of the same profession, or a group of physicians’ offices (whether owned 29 |
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295 | 295 | | and/or operated by an individual practitioner, alone or as a member of a partnership, professional 30 |
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296 | 296 | | service corporation, limited-liability company, organization, or association). 31 |
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297 | 297 | | (18) “Podiatry ambulatory-surgery center” means an office or portion of an office that is 32 |
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298 | 298 | | utilized for the purpose of furnishing surgical services to the owner and/or operator’s own patients 33 |
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299 | 299 | | on an ambulatory basis, and shall include both single-practice, podiatry ambulatory-surgery centers 34 |
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300 | 300 | | |
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301 | 301 | | |
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302 | 302 | | LC001692 - Page 9 of 14 |
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303 | 303 | | and multi-practice podiatry ambulatory-surgery centers. A “single-practice podiatry ambulatory-1 |
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304 | 304 | | surgery center” is a podiatry ambulatory center owned and/or operated by a podiatrist-controlled 2 |
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305 | 305 | | professional service corporation (as defined in chapter 5.1 of title 7 (the “professional service 3 |
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306 | 306 | | corporation law”)), or a podiatrist-controlled limited-liability company (as defined in chapter 16 of 4 |
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307 | 307 | | title 7 (the “limited liability company act”)) in which no podiatrist is an officer, shareholder, 5 |
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308 | 308 | | director, or employee of any other corporation engaged in the practice of the same profession, or a 6 |
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309 | 309 | | private podiatrist’s office (whether owned and/or operated by an individual practitioner, alone or 7 |
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310 | 310 | | as a member of a partnership, professional service corporation, limited-liability company, 8 |
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311 | 311 | | organization, or association). A “multi-practice, podiatry ambulatory-surgery center” is a podiatry 9 |
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312 | 312 | | ambulatory-surgery center owned and/or operated by a podiatrist-controlled professional service 10 |
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313 | 313 | | corporation (as defined in the professional service corporation law) or a podiatrist-controlled, 11 |
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314 | 314 | | limited-liability company (as defined in the limited liability company act) in which a podiatrist is 12 |
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315 | 315 | | also an officer, shareholder, director, or employee of another corporation engaged in the practice 13 |
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316 | 316 | | of the same profession, or a group of podiatrists’ offices (whether owned and/or operated by an 14 |
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317 | 317 | | individual practitioner, alone or as a member of a partnership, professional service corporation, 15 |
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318 | 318 | | limited-liability company, organization, or association). 16 |
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319 | 319 | | (19) “Qualified interpreter” means a person who, through experience and/or training, is 17 |
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320 | 320 | | able to translate a particular foreign language into English, with the exception of sign-language 18 |
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321 | 321 | | interpreters who must be licensed in accordance with chapter 71 of title 5. 19 |
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322 | 322 | | (20) “Qualified sign-language interpreter” means one who has been licensed in accordance 20 |
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323 | 323 | | with the provisions of chapter 71 of title 5. 21 |
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324 | 324 | | (21) “School-based health center” means a facility located in an elementary or secondary 22 |
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325 | 325 | | school licensed as a school-based health center that delivers primary and/or preventive healthcare 23 |
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326 | 326 | | services to individuals to include, but not be limited to, students on site. 24 |
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327 | 327 | | SECTION 3. Section 23-15-2 of the General Laws in Chapter 23-15 entitled 25 |
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328 | 328 | | "Determination of Need for New Healthcare Equipment and New Institutional Health Services" is 26 |
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329 | 329 | | hereby amended to read as follows: 27 |
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330 | 330 | | 23-15-2. Definitions. 28 |
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331 | 331 | | As used in this chapter: 29 |
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332 | 332 | | (1) “Affected person” means and includes the person whose proposal is being reviewed, or 30 |
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333 | 333 | | the applicant, healthcare facilities located within the state that provide institutional health services, 31 |
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334 | 334 | | the state medical society, the state osteopathic society, those voluntary nonprofit area-wide 32 |
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335 | 335 | | planning agencies that may be established in the state, the state budget office, the office of health 33 |
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336 | 336 | | insurance commissioner, any hospital or medical-service corporation organized under the laws of 34 |
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337 | 337 | | |
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338 | 338 | | |
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339 | 339 | | LC001692 - Page 10 of 14 |
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340 | 340 | | the state, the statewide health coordinating council, contiguous health-systems agencies, and those 1 |
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341 | 341 | | members of the public who are to be served by the proposed, new institutional health services or 2 |
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342 | 342 | | new healthcare equipment. 3 |
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343 | 343 | | (2) “Cost-impact analysis” means a written analysis of the effect that a proposal to offer or 4 |
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344 | 344 | | develop new institutional health services or new healthcare equipment, if approved, will have on 5 |
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345 | 345 | | healthcare costs and shall include any detail that may be prescribed by the state agency in rules and 6 |
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346 | 346 | | regulations. 7 |
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347 | 347 | | (3) “Director” means the director of the Rhode Island state department of health. 8 |
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348 | 348 | | (4)(i) “Healthcare facility” means any institutional health-service provider, facility or 9 |
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349 | 349 | | institution, place, building, agency, or portion of them, whether a partnership or corporation, 10 |
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350 | 350 | | whether public or private, whether organized for profit or not, used, operated, or engaged in 11 |
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351 | 351 | | providing healthcare services that are limited to hospitals, nursing facilities, home nursing-care 12 |
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352 | 352 | | provider, home-care provider, hospice provider, inpatient rehabilitation centers (including drug 13 |
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353 | 353 | | and/or alcohol abuse treatment centers), freestanding emergency-care facilities as defined in § 23-14 |
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354 | 354 | | 17-2, certain facilities providing surgical treatment to patients not requiring hospitalization (surgi-15 |
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355 | 355 | | centers, multi-practice, physician ambulatory-surgery centers and multi-practice, podiatry 16 |
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356 | 356 | | ambulatory-surgery centers) and facilities providing inpatient hospice care. Single-practice 17 |
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357 | 357 | | physician or podiatry ambulatory-surgery centers (as defined in § 23-17-2(17), (18), respectively) 18 |
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358 | 358 | | are exempt from the requirements of chapter 15 of this title; provided, however, that such 19 |
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359 | 359 | | exemption shall not apply if a single-practice physician or podiatry ambulatory-surgery center is 20 |
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360 | 360 | | established by a medical practice group (as defined in § 5-37-1) within two (2) years following the 21 |
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361 | 361 | | formation of such medical practice group, when such medical practice group is formed by the 22 |
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362 | 362 | | merger or consolidation of two (2) or more medical practice groups or the acquisition of one 23 |
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363 | 363 | | medical practice group by another medical practice group. Medical spas as defined in chapter 99 24 |
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364 | 364 | | of title 23 are exempt from the requirements of chapter 15 of this title. The term “healthcare facility” 25 |
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365 | 365 | | does not include Christian Science institutions (also known as Christian Science nursing facilities) 26 |
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366 | 366 | | listed and certified by the Commission for Accreditation of Christian Science Nursing 27 |
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367 | 367 | | Organizations/Facilities, Inc. 28 |
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368 | 368 | | (ii) Any provider of hospice care who provides hospice care without charge shall be exempt 29 |
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369 | 369 | | from the provisions of this chapter. 30 |
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370 | 370 | | (5) “Healthcare provider” means a person who is a direct provider of healthcare services 31 |
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371 | 371 | | (including but not limited to physicians, dentists, nurses, podiatrists, physician assistants, or nurse 32 |
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372 | 372 | | practitioners) in that the person’s primary current activity is the provision of healthcare services for 33 |
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373 | 373 | | persons. 34 |
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374 | 374 | | |
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375 | 375 | | |
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376 | 376 | | LC001692 - Page 11 of 14 |
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377 | 377 | | (6) “Health services” means organized program components for preventive, assessment, 1 |
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378 | 378 | | maintenance, diagnostic, treatment, and rehabilitative services provided in a healthcare facility. 2 |
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379 | 379 | | (7) “Health services council” means the advisory body to the Rhode Island state department 3 |
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380 | 380 | | of health established in accordance with chapter 17 of this title, appointed and empowered as 4 |
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381 | 381 | | provided to serve as the advisory body to the state agency in its review functions under this chapter. 5 |
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382 | 382 | | (8) “Institutional health services” means health services provided in or through healthcare 6 |
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383 | 383 | | facilities and includes the entities in or through that the services are provided. 7 |
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384 | 384 | | (9) “New healthcare equipment” means any single piece of medical equipment (and any 8 |
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385 | 385 | | components that constitute operational components of the piece of medical equipment) proposed 9 |
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386 | 386 | | to be utilized in conjunction with the provision of services to patients or the public, the capital costs 10 |
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387 | 387 | | of which would exceed two million two hundred fifty thousand dollars ($2,250,000); provided, 11 |
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388 | 388 | | however, that the state agency shall exempt from review any application that proposes one-for-one 12 |
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389 | 389 | | equipment replacement as defined in regulation. Further, beginning July 1, 2012, and each July 13 |
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390 | 390 | | thereafter, the amount shall be adjusted by the percentage of increase in the consumer price index 14 |
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391 | 391 | | for all urban consumers (CPI-U) as published by the United States Department of Labor Statistics 15 |
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392 | 392 | | as of September 30 of the prior calendar year. 16 |
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393 | 393 | | (10) “New institutional health services” means and includes: 17 |
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394 | 394 | | (i) Construction, development, or other establishment of a new healthcare facility. 18 |
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395 | 395 | | (ii) Any expenditure, except acquisitions of an existing healthcare facility, that will not 19 |
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396 | 396 | | result in a change in the services or bed capacity of the healthcare facility by, or on behalf of, an 20 |
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397 | 397 | | existing healthcare facility in excess of five million two hundred fifty thousand dollars ($5,250,000) 21 |
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398 | 398 | | which is a capital expenditure including expenditures for predevelopment activities; provided 22 |
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399 | 399 | | further, beginning July 1, 2012, and each July thereafter, the amount shall be adjusted by the 23 |
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400 | 400 | | percentage of increase in the consumer price index for all urban consumers (CPI-U) as published 24 |
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401 | 401 | | by the United States Department of Labor Statistics as of September 30 of the prior calendar year. 25 |
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402 | 402 | | (iii) Where a person makes an acquisition by, or on behalf of, a healthcare facility or health 26 |
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403 | 403 | | maintenance organization under lease or comparable arrangement or through donation, which 27 |
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404 | 404 | | would have required review if the acquisition had been by purchase, the acquisition shall be deemed 28 |
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405 | 405 | | a capital expenditure subject to review. 29 |
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406 | 406 | | (iv) Any capital expenditure that results in the addition of a health service or that changes 30 |
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407 | 407 | | the bed capacity of a healthcare facility with respect to which the expenditure is made, except that 31 |
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408 | 408 | | the state agency may exempt from review, by rules and regulations promulgated for this chapter, 32 |
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409 | 409 | | any bed reclassifications made to licensed nursing facilities and annual increases in licensed bed 33 |
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410 | 410 | | capacities of nursing facilities that do not exceed the greater of ten (10) beds or ten percent (10%) 34 |
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411 | 411 | | |
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412 | 412 | | |
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413 | 413 | | LC001692 - Page 12 of 14 |
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414 | 414 | | of facility licensed bed capacity and for which the related capital expenditure does not exceed two 1 |
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415 | 415 | | million dollars ($2,000,000). 2 |
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416 | 416 | | (v) Any health service proposed to be offered to patients or the public by a healthcare 3 |
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417 | 417 | | facility that was not offered on a regular basis in or through the facility within the twelve-month 4 |
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418 | 418 | | (12) period prior to the time the service would be offered, and that increases operating expenses by 5 |
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419 | 419 | | more than one million five hundred thousand dollars ($1,500,000), except that the state agency may 6 |
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420 | 420 | | exempt from review, by rules and regulations promulgated for this chapter, any health service 7 |
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421 | 421 | | involving reclassification of bed capacity made to licensed nursing facilities. Further, beginning 8 |
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422 | 422 | | July 1, 2012, and each July thereafter, the amount shall be adjusted by the percentage of increase 9 |
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423 | 423 | | in the consumer price index for all urban consumers (CPI-U) as published by the United States 10 |
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424 | 424 | | Department of Labor Statistics as of September 30 of the prior calendar year. 11 |
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425 | 425 | | (vi) Any new or expanded tertiary or specialty-care service, regardless of capital expense 12 |
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426 | 426 | | or operating expense, as defined by and listed in regulation, the list not to exceed a total of twelve 13 |
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427 | 427 | | (12) categories of services at any one time and shall include full-body magnetic resonance imaging 14 |
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428 | 428 | | and computerized axial tomography; provided, however, that the state agency shall exempt from 15 |
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429 | 429 | | review any application that proposes one-for-one equipment replacement as defined by and listed 16 |
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430 | 430 | | in regulation. Acquisition of full body magnetic resonance imaging and computerized axial 17 |
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431 | 431 | | tomography shall not require a certificate-of-need review and approval by the state agency if 18 |
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432 | 432 | | satisfactory evidence is provided to the state agency that it was acquired for under one million 19 |
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433 | 433 | | dollars ($1,000,000) on or before January 1, 2010, and was in operation on or before July 1, 2010. 20 |
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434 | 434 | | (11) “Person” means any individual, trust or estate, partnership, corporation (including 21 |
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435 | 435 | | associations, joint stock companies, and insurance companies), state or political subdivision, or 22 |
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436 | 436 | | instrumentality of a state. 23 |
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437 | 437 | | (12) “Predevelopment activities” means expenditures for architectural designs, plans, 24 |
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438 | 438 | | working drawings, and specifications, site acquisition, professional consultations, preliminary 25 |
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439 | 439 | | plans, studies, and surveys made in preparation for the offering of a new, institutional health 26 |
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440 | 440 | | service. 27 |
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441 | 441 | | (13) “State agency” means the Rhode Island state department of health. 28 |
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442 | 442 | | (14) “To develop” means to undertake those activities that, on their completion, will result 29 |
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443 | 443 | | in the offering of a new, institutional health service or new healthcare equipment or the incurring 30 |
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444 | 444 | | of a financial obligation, in relation to the offering of that service. 31 |
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445 | 445 | | (15) “To offer” means to hold oneself out as capable of providing, or as having the means 32 |
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446 | 446 | | for the provision of, specified health services or healthcare equipment. 33 |
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447 | 447 | | |
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448 | 448 | | |
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449 | 449 | | LC001692 - Page 13 of 14 |
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450 | 450 | | SECTION 4. This act shall take effect upon passage. 1 |
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451 | 451 | | ======== |
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452 | 452 | | LC001692 |
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454 | 454 | | |
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455 | 455 | | |
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456 | 456 | | LC001692 - Page 14 of 14 |
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457 | 457 | | EXPLANATION |
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458 | 458 | | BY THE LEGISLATIVE COUNCIL |
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459 | 459 | | OF |
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460 | 460 | | A N A C T |
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461 | 461 | | RELATING TO HEALTH AND SAFETY -- MEDICAL SPAS SAFETY ACT |
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462 | 462 | | *** |
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463 | 463 | | This act would provide that the performance of cosmetic medical services is the practice 1 |
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464 | 464 | | of medicine and surgery. This act would also provide that a cosmetic medical service would be 2 |
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465 | 465 | | performed by a qualified licensed or certified non-physician only if the services have been 3 |
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466 | 466 | | delegated by a medical director, supervising physician, supervising physician assistant, or 4 |
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467 | 467 | | supervising APRN who is responsible for on-site supervision of the services performed. 5 |
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468 | 468 | | This act would take effect upon passage. 6 |
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469 | 469 | | ======== |
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470 | 470 | | LC001692 |
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