37 | 33 | | HOUSE SPONSORSHIP |
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38 | 34 | | Martinez and Taggart, |
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39 | 35 | | Shading denotes HOUSE amendment. Double underlining denotes SENATE amendment. |
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40 | 36 | | Capital letters or bold & italic numbers indicate new material to be added to existing law. |
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41 | 37 | | Dashes through the words or numbers indicate deletions from existing law. programs. |
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42 | 38 | | Unless the receipt of 340B drugs is prohibited by the federal |
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43 | 39 | | department of health and human services, the bill prohibits a |
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44 | 40 | | manufacturer, wholesaler, third-party logistics provider, or repackager in |
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45 | 41 | | this state, or an agent, contractor, or affiliate of those entities, including |
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46 | 42 | | an entity that collects or processes health information, from directly or |
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47 | 43 | | indirectly denying, restricting, prohibiting, discriminating against, or |
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48 | 44 | | otherwise limiting the acquisition of a 340B drug by, or delivery of a |
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49 | 45 | | 340B drug to, a covered entity, a pharmacy contracted with a covered |
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50 | 46 | | entity, or a location otherwise authorized by a covered entity to receive |
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51 | 47 | | and dispense 340B drugs. |
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52 | 48 | | The bill also prohibits a manufacturer from directly or indirectly |
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53 | 49 | | requiring a covered entity, a pharmacy contracted with a covered entity, |
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54 | 50 | | or any other location authorized to receive 340B drugs by a covered entity |
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55 | 51 | | to submit any health information, claims or utilization data, or other |
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56 | 52 | | specified data that does not relate to a claim submitted to certain federal |
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57 | 53 | | health care programs, unless the data is voluntarily furnished or required |
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58 | 54 | | to be furnished under federal law. |
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59 | 55 | | A violation of the prohibitions in the bill is an unfair or deceptive |
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60 | 56 | | trade practice under the "Colorado Consumer Protection Act" (act), and |
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61 | 57 | | the violator is subject to the enforcement provisions and penalties |
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62 | 58 | | contained in that act. The attorney general may investigate and enforce |
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63 | 59 | | the provisions of the bill, as well as a business harmed by a violation of |
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64 | 60 | | the provisions of the bill. In addition, a person regulated by the state |
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65 | 61 | | board of pharmacy (pharmacy board) that violates the provisions of the |
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66 | 62 | | bill may be subject to discipline by the pharmacy board against the |
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67 | 63 | | person's license, certification, or registration, as well as other penalties. |
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68 | 64 | | The bill requires a covered entity that is a hospital to annually post |
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69 | 65 | | on its public-facing website information concerning the annual, estimated, |
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70 | 66 | | aggregate financial benefit to the hospital covered entity resulting from |
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71 | 67 | | its ability to acquire pharmaceuticals at a discount through the 340B |
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72 | 68 | | program and a description of how the hospital covered entity uses savings |
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73 | 69 | | from participation in the 340B program. |
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74 | 70 | | Be it enacted by the General Assembly of the State of Colorado:1 |
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75 | 71 | | SECTION 1. In Colorado Revised Statutes, 6-1-105, add (1)(iiii)2 |
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76 | 72 | | as follows:3 |
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77 | 73 | | 6-1-105. Unfair or deceptive trade practices - definitions.4 |
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78 | 74 | | (1) A person engages in a deceptive trade practice when, in the course of5 |
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79 | 75 | | the person's business, vocation, or occupation, the person:6 |
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80 | 76 | | 071-2- (iiii) VIOLATES ARTICLE 29 OF THIS TITLE 6.1 |
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81 | 77 | | SECTION 2. In Colorado Revised Statutes, add article 29 to title2 |
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82 | 78 | | 6 as follows:3 |
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83 | 79 | | ARTICLE 294 |
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84 | 80 | | Colorado 340B Contract Pharmacy Protection Act5 |
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85 | 81 | | 6-29-101. Short title. T |
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86 | 82 | | HE SHORT TITLE OF THIS ARTICLE 29 IS THE6 |
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87 | 83 | | "C |
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88 | 84 | | OLORADO 340B CONTRACT PHARMACY PROTECTION ACT".7 |
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89 | 85 | | 6-29-102. Legislative declaration. (1) T |
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90 | 86 | | HE GENERAL ASSEMBLY8 |
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91 | 87 | | FINDS AND DETERMINES THAT:9 |
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92 | 88 | | (a) T |
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93 | 89 | | HE 340B DRUG PRICING PROGRAM REQUIRES DRUG10 |
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94 | 90 | | MANUFACTURERS TO PROVIDE DRUG DISCOUNTS ON IDENTIFIED11 |
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95 | 91 | | OUTPATIENT DRUGS TO 340B COVERED ENTITIES AS A CONDITION OF12 |
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96 | 92 | | MEDICAID AND MEDICARE PART B COVERING THOSE DRUGS;13 |
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97 | 93 | | (b) C |
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98 | 94 | | ONGRESS CREATED THE 340B PROGRAM IN 1992, STATING14 |
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99 | 95 | | THAT THE PROGRAM'S BENEFITS "ENABLE [COVERED] ENTITIES TO STRETCH15 |
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100 | 96 | | SCARCE FEDERAL RESOURCES AS FAR AS POSSIBLE , REACHING MORE16 |
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101 | 97 | | ELIGIBLE PATIENTS AND PROVIDING MORE COMPREHENSIVE SERVICES ."17 |
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102 | 98 | | (H.R. |
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103 | 99 | | REP. NO.102-384 (II), AT 12 (1992)).18 |
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104 | 100 | | (c) T |
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105 | 101 | | HE 340B PROGRAM SUPPORTS COLORADO'S MEDICALLY19 |
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106 | 102 | | VULNERABLE AND UNDERSERVED POPULATIONS BY PROVIDING20 |
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107 | 103 | | ADDITIONAL RESOURCES TO 340B COVERED ENTITIES AND ALLOWING21 |
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108 | 104 | | THESE ENTITIES TO DETERMINE THE MOST EFFECTIVE USE OF THESE22 |
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109 | 105 | | RESOURCES;23 |
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110 | 106 | | (d) T |
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111 | 107 | | HE 340B PROGRAM IS A CRITICAL COMPONENT OF24 |
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112 | 108 | | C |
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113 | 109 | | OLORADO'S SAFETY NET INFRASTRUCTURE;25 |
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114 | 110 | | (e) C |
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115 | 111 | | OLORADO HAS SIXTY-EIGHT HOSPITALS STATEWIDE THAT26 |
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116 | 112 | | PARTICIPATE IN THE 340B PROGRAM, WITH NEARLY NINETY PERCENT OF27 |
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117 | 113 | | 071 |
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118 | 114 | | -3- THESE HOSPITALS OPERATING UNDER UNSUSTAINABLE LONG -TERM1 |
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119 | 115 | | MARGINS;2 |
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120 | 116 | | (f) A |
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121 | 117 | | DDITIONALLY, COLORADO HAS TWENTY FEDERALLY3 |
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122 | 118 | | QUALIFIED HEALTH CENTERS, OR FQHCS, ALL OF WHICH PARTICIPATE IN4 |
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123 | 119 | | THE 340B PROGRAM AND SIXTY-FIVE PERCENT OF WHICH CURRENTLY5 |
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124 | 120 | | OPERATE WITH NEGATIVE MARGINS ;6 |
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125 | 121 | | (g) C |
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126 | 122 | | OLORADO HOSPITALS PARTICIPATING IN THE 340B PROGRAM7 |
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127 | 123 | | UTILIZE PROGRAM BENEFITS TO ADDRESS THEIR COMMUNITIES ' UNIQUE8 |
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128 | 124 | | NEEDS, WHICH INCLUDE PROVIDING DIRECT PRESCRIPTION DRUG9 |
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129 | 125 | | DISCOUNTS, SUBSIDIZING UNCOMPENSATED CHARITY CARE AND MEDICAID10 |
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130 | 126 | | UNDERPAYMENTS TO REMAIN FINANCIALLY OPERATIONAL , SUPPORTING11 |
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131 | 127 | | OPIOID USE DISORDER TREATMENT , FUNDING MOBILE HEALTH-CARE AND12 |
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132 | 128 | | IMMUNIZATION CLINICS, AND PAYING FOR CHEMOTHERAPY AND INFUSION13 |
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133 | 129 | | CENTERS;14 |
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134 | 130 | | (h) C |
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135 | 131 | | OLORADO'S FQHCS ARE THE PRIMARY CARE MEDICAL HOME15 |
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136 | 132 | | FOR ONE IN SEVEN COLORADANS, WITH EIGHTY-NINE PERCENT OF FQHCS'16 |
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137 | 133 | | PATIENTS IN 2023 LIVING WITH FAMILY INCOMES BELOW TWO HUNDRED17 |
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138 | 134 | | PERCENT OF THE FEDERAL POVERTY GUIDELINE AND TWENTY -THREE18 |
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139 | 135 | | PERCENT WERE UNINSURED ;19 |
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140 | 136 | | (i) C |
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141 | 137 | | OLORADO'S FQHCS UTILIZE 340B PROGRAM BENEFITS TO20 |
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142 | 138 | | ADDRESS THEIR COMMUNITIES' UNIQUE NEEDS, WHICH INCLUDE REDUCED21 |
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143 | 139 | | DRUG PRICES FOR PATIENTS, PROVIDER RECRUITMENT AND RETENTION ,22 |
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144 | 140 | | AND EXPANSION OF ORAL HEALTH AND BEHAVIORAL HEALTH SERVICES23 |
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145 | 141 | | THAT THE FQHCS WOULD OTHERWISE NOT BE ABLE TO OFFER ;24 |
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146 | 142 | | (j) F |
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147 | 143 | | URTHER, COLORADO'S FQHCS EXPERIENCED AN ESTIMATED25 |
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148 | 144 | | LOSS OF FOUR MILLION THREE HUNDRED DOLLARS IN 340B PROGRAM26 |
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149 | 145 | | SAVINGS IN THE LAST TWO YEARS;27 |
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150 | 146 | | 071 |
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151 | 147 | | -4- (k) CONVERSELY, IN 2023, SIXTEEN OF THE LARGEST1 |
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152 | 148 | | PHARMACEUTICAL COMPANIES REPORTED SIX HUNDRED EIGHTY -FOUR2 |
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153 | 149 | | BILLION DOLLARS IN EARNINGS IN THEIR ANNUAL FINANCIAL REPORTS , A3 |
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154 | 150 | | FIGURE THAT WAS HIGHER THAN THE GROSS DOMESTIC PR ODUCT OF4 |
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155 | 151 | | EIGHTY-EIGHT PERCENT OF THE COUNTRIES IN THE WORLD ;5 |
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156 | 152 | | (l) I |
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157 | 153 | | N ADDITION, THE EIGHT LARGEST PHARMACEUTICAL6 |
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158 | 154 | | COMPANIES PAID A COMBINED TWO BILLION DOLLARS IN FEDERAL TAXES7 |
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159 | 155 | | ON TWO HUNDRED FOURTEEN BILLION DOLLARS OF DOMESTIC REVENUE IN8 |
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160 | 156 | | 2022, |
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161 | 157 | | ACCORDING TO THEIR 10-K ANNUAL FINANCIAL REPORTS;9 |
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162 | 158 | | (m) I |
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163 | 159 | | N 2022, COLORADO HOSPITALS PROVIDED TWO BILLION ONE10 |
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164 | 160 | | HUNDRED MILLION DOLLARS OF COMMUNITY BENEFIT ;11 |
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165 | 161 | | (n) S |
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166 | 162 | | TARTING IN 2020, PHARMACEUTICAL MANUFACTURERS BEGAN12 |
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167 | 163 | | TO UNLAWFULLY PLACE RESTRICTIONS ON 340B COVERED ENTITIES USING13 |
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168 | 164 | | CONTRACT PHARMACIES TO DISPENSE DRUGS TO PATIENTS , UNILATERALLY14 |
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169 | 165 | | LIMITING THE 340B PROGRAM'S BENEFITS; AND15 |
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170 | 166 | | (o) I |
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171 | 167 | | N A LETTER DATED JULY 28, 2023, FROM WILLIAM TONG,16 |
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172 | 168 | | ATTORNEY GENERAL OF CONNECTICUT, TO THE UNITED STATES SENATE17 |
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173 | 169 | | 340B |
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174 | 170 | | WORKING GROUP, AND SIGNED BY TWENTY-TWO OTHER BIPARTISAN18 |
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175 | 171 | | ATTORNEYS GENERAL , THE ATTORNEYS GENERAL DECLARED THAT19 |
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176 | 172 | | " |
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177 | 173 | | OUTPATIENT PHARMACIES ARE A KEY MECHANISM FOR THE DELIVERY OF20 |
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178 | 174 | | LIFE-SAVING DRUGS TO ELIGIBLE PATIENTS, INCLUDING THOSE WHO HAVE21 |
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179 | 175 | | LIMITED ACCESS TO TRANSPORTATION , LIVE IN REMOTE OR RURAL AREAS,22 |
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180 | 176 | | OR ARE CONFINED TO THEIR HOMES AND RELY ON MAIL -ORDER23 |
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181 | 177 | | PHARMACIES."24 |
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182 | 178 | | (2) T |
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183 | 179 | | HEREFORE, THE GENERAL ASSEMBLY DECLARES THAT THIS25 |
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184 | 180 | | ARTICLE 29 PROHIBITING PHARMACEUTICAL MANUFACTURERS FROM26 |
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185 | 181 | | IMPOSING LIMITATIONS OR PLACING RESTRICTIVE CONDITIONS ON 340B27 |
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186 | 182 | | 071 |
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187 | 183 | | -5- COVERED ENTITIES IS NECESSARY TO PROTECT COLORADO'S VULNERABLE1 |
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188 | 184 | | PATIENTS AND SAFETY NET PROVIDERS AND TO ENSURE THAT2 |
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189 | 185 | | MUCH-NEEDED FINANCIAL RESOURCES GENERATED BY THE 340B PROGRAM3 |
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190 | 186 | | REMAIN IN COLORADO FOR THE BENEFIT OF THE PUBLIC .4 |
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191 | 187 | | 6-29-103. Definitions. A |
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192 | 188 | | S USED IN THIS ARTICLE 29, UNLESS THE5 |
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193 | 189 | | CONTEXT OTHERWISE REQUIRES :6 |
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194 | 190 | | (1) "340B |
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195 | 191 | | COVERED ENTITY" OR "COVERED ENTITY" HAS THE7 |
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196 | 192 | | MEANING SET FORTH IN SECTION 340B (a)(4) OF THE FEDERAL "PUBLIC8 |
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197 | 193 | | H |
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198 | 194 | | EALTH SERVICE ACT", 42 U.S.C. SEC. 256b (a)(4).9 |
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199 | 195 | | (2) "340B |
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200 | 196 | | DRUG" MEANS A DRUG THAT:10 |
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201 | 197 | | (a) I |
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202 | 198 | | S A COVERED OUTPATIENT DRUG WITHIN THE MEANING SET11 |
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203 | 199 | | FORTH IN 42 U.S.C. SEC. 256b;12 |
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204 | 200 | | (b) H |
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205 | 201 | | AS BEEN SUBJECT TO ANY OFFER FOR REDUCED PRICES BY A13 |
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206 | 202 | | MANUFACTURER PURSUANT TO 42 U.S.C. SEC. 256b (a)(1); AND14 |
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207 | 203 | | (c) I |
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208 | 204 | | S PURCHASED BY A COVERED ENTITY . AS USED IN THIS15 |
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209 | 205 | | SUBSECTION (2)(c), A DRUG IS CONSIDERED "PURCHASED" IF IT WOULD16 |
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210 | 206 | | HAVE BEEN PURCHASED BUT FOR THE RESTRICTION OR LIMITATION17 |
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211 | 207 | | DESCRIBED IN SECTION 6-29-105.18 |
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212 | 208 | | (3) "340B |
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213 | 209 | | DRUG PRICING PROGRAM" OR "340B PROGRAM" MEANS19 |
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214 | 210 | | THE PROGRAM DESCRIBED IN 42 U.S.C. SEC. 256b (a)(1).20 |
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215 | 211 | | (4) "340B |
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216 | 212 | | SAVINGS" MEANS THE DIFFERENCE BETWEEN THE |
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217 | 213 | | 21 |
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218 | 214 | | AGGREGATED MARKET RATE COSTS AND THE AGGREGATED ACQUISITION22 |
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219 | 215 | | COSTS FOR 340B DRUGS.23 |
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220 | 216 | | (5) "BOARD" MEANS THE STATE BOARD OF PHARMACY CREATED IN24 |
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221 | 217 | | SECTION 12-280-104.25 |
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222 | 218 | | (6) "FEDERAL HEALTH CARE PROGRAM " HAS THE MEANING SET26 |
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223 | 219 | | FORTH IN SECTION 42 U.S.C. SEC. 1320a-7b (f).27 |
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224 | 220 | | 071 |
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225 | 221 | | -6- (7) "HEALTH INFORMATION" MEANS INFORMATION, INCLUDING1 |
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226 | 222 | | DEMOGRAPHIC INFORMATION COLLECTED FROM AN INDIVIDUAL OR A2 |
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227 | 223 | | GROUP OF INDIVIDUALS THAT:3 |
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228 | 224 | | (a) I |
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229 | 225 | | S CREATED OR RECEIVED BY A HEALTH -CARE PROVIDER,4 |
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230 | 226 | | PHARMACY, HEALTH BENEFIT PLAN , EMPLOYER, OR HEALTH-CARE5 |
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231 | 227 | | CLEARINGHOUSE; AND6 |
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232 | 228 | | (b) R |
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233 | 229 | | ELATES TO THE PAST, PRESENT, OR FUTURE PHYSICAL OR7 |
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234 | 230 | | MENTAL HEALTH OR CONDITION OF AN INDIVIDUAL , THE PROVISION OF8 |
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235 | 231 | | HEALTH CARE TO AN INDIVIDUAL , OR THE PAST, PRESENT, OR FUTURE9 |
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236 | 232 | | PAYMENT FOR THE PROVISION OF HEALTH CARE TO AN INDIVIDUAL .10 |
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237 | 233 | | (8) |
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238 | 234 | | "MANUFACTURER" HAS THE MEANING SET FORTH IN SECTION11 |
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239 | 235 | | 12-280-103 |
---|
240 | 236 | | (27).12 |
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241 | 237 | | (9) |
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242 | 238 | | "PACKAGE" HAS THE MEANING SET FORTH IN 21 U.S.C. SEC.13 |
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243 | 239 | | 360eee (11)(A).14 |
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244 | 240 | | (10) "PHARMACY" HAS THE MEANING SET FORTH IN SECTION15 |
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245 | 241 | | 12-280-103 |
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246 | 242 | | (43).16 |
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247 | 243 | | (11) |
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248 | 244 | | "REPACKAGER" HAS THE MEANING SET FORTH IN SECTION17 |
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249 | 245 | | 12-280-103 |
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250 | 246 | | (46).18 |
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251 | 247 | | (12) |
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252 | 248 | | "THIRD-PARTY LOGISTICS PROVIDER" HAS THE MEANING SET19 |
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253 | 249 | | FORTH IN SECTION 12-280-103 (52.5).20 |
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254 | 250 | | 21 |
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255 | 251 | | 6-29-104. Applicability. T |
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256 | 252 | | HIS ARTICLE 29 APPLIES TO A22 |
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257 | 253 | | MANUFACTURER, |
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258 | 254 | | THIRD-PARTY LOGISTICS PROVIDER, OR REPACKAGER23 |
---|
259 | 255 | | OF A MANUFACTURER 'S DRUGS DOING BUSINESS IN THIS STATE AND24 |
---|
260 | 256 | | ENGAGED IN THE PRODUCTION, MANUFACTURE, DISTRIBUTION, OR SALE OF25 |
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261 | 257 | | A 340B DRUG IN THIS STATE.26 |
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262 | 258 | | 6-29-105. Acquisition of 340B drugs - prohibited acts - use of27 |
---|
263 | 259 | | 071 |
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264 | 260 | | -7- savings - enforcement - penalties - nonpreemption - data exclusions.1 |
---|
265 | 261 | | (1) Prohibited acts. O |
---|
266 | 262 | | N AND AFTER THE EFFECTIVE DATE OF THIS2 |
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267 | 263 | | ARTICLE 29:3 |
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268 | 264 | | (a) U |
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269 | 265 | | NLESS THE RECEIPT OF THE 340B DRUGS IS PROHIBITED BY4 |
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270 | 266 | | THE FEDERAL DEPARTMENT OF HEALTH AND HUMAN SERVICES , A5 |
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271 | 267 | | MANUFACTURER, |
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272 | 268 | | THIRD-PARTY LOGISTICS PROVIDER, OR REPACKAGER,6 |
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273 | 269 | | OR AN AGENT, CONTRACTOR, OR AFFILIATE OF A MANUFACTURER , 7 |
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274 | 270 | | THIRD-PARTY LOGISTICS PROVIDER , OR REPACKAGER, INCLUDING AN8 |
---|
275 | 271 | | ENTITY THAT COLLECTS OR PROCESSES HEALTH INFORMATION , SHALL NOT,9 |
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276 | 272 | | DIRECTLY OR INDIRECTLY, DENY, RESTRICT, PROHIBIT, DISCRIMINATE10 |
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277 | 273 | | AGAINST, OR OTHERWISE LIMIT THE ACQUISITION OF A 340B DRUG BY, OR11 |
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278 | 274 | | DELIVERY OF A 340B DRUG TO, A 340B COVERED ENTITY, A PHARMACY12 |
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279 | 275 | | CONTRACTED WITH A 340B COVERED ENTITY, OR A LOCATION OTHERWISE13 |
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280 | 276 | | AUTHORIZED BY A 340B COVERED ENTITY TO RECEIVE AND DISPENSE 340B14 |
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281 | 277 | | DRUGS; AND15 |
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282 | 278 | | (b) A |
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283 | 279 | | MANUFACTURER SHALL NOT DIRECTLY OR INDIRECTLY16 |
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284 | 280 | | REQUIRE, INCLUDING AS A CONDITION , A 340B COVERED ENTITY, A17 |
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285 | 281 | | PHARMACY CONTRACTED WITH A 340B COVERED ENTITY, OR ANY OTHER18 |
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286 | 282 | | LOCATION AUTHORIZED TO RECEIVE 340B DRUGS BY A 340B COVERED19 |
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287 | 283 | | ENTITY TO SUBMIT ANY HEALTH INFORMATION , CLAIMS OR UTILIZATION20 |
---|
288 | 284 | | DATA, PURCHASING DATA, PAYMENT DATA, OR OTHER DATA THAT DOES21 |
---|
289 | 285 | | NOT RELATE TO A CLAIM SUBMITTED TO A FEDERAL HEALTH CARE22 |
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290 | 286 | | PROGRAM, UNLESS SUCH DATA IS VOLUNTARILY FURNISHED BY SUCH23 |
---|
291 | 287 | | COVERED ENTITY OR OTHERWISE REQUIRED TO BE FURNISHED UNDER24 |
---|
292 | 288 | | APPLICABLE FEDERAL LAW.25 |
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293 | 289 | | (2) A |
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294 | 290 | | COVERED ENTITY THAT IS A REPORTING HOSPITAL , AS |
---|
295 | 291 | | 26 |
---|
296 | 292 | | DEFINED IN SECTION 25.5-1-701, SHALL NOT USE 340B SAVINGS FOR THE27 |
---|
297 | 293 | | 071 |
---|
298 | 294 | | -8- FOLLOWING PURPOSES:1 |
---|
299 | 295 | | (a) M |
---|
300 | 296 | | ORE THAN THIRTY-FIVE PERCENT OF TOTAL ANNUAL |
---|
301 | 297 | | 2 |
---|
302 | 298 | | COMPENSATION OR EXPENSE REIMBURSEMENT FOR THE HOSPITAL 'S BOARD3 |
---|
303 | 299 | | OF DIRECTORS;4 |
---|
304 | 300 | | (b) T |
---|
305 | 301 | | AX PENALTIES OR FINES ISSUED AGAINST THE HOSPITAL ; |
---|
306 | 302 | | 5 |
---|
307 | 303 | | (c) E |
---|
308 | 304 | | XPENSES RELATED TO ADVERTISING AND PUBLIC RELATIONS |
---|
309 | 305 | | 6 |
---|
310 | 306 | | THAT PROMOTE THE HOSPITAL 'S IMAGE, SERVICES, OR PROPOSALS, NOT7 |
---|
311 | 307 | | INCLUDING COMMUNICATIONS REQUIRED BY LAW OR THAT ARE ESSENTIAL8 |
---|
312 | 308 | | FOR PATIENT SAFETY AND PATIENT INFORMATION ;9 |
---|
313 | 309 | | (d) L |
---|
314 | 310 | | OBBYING EXPENSES AND OTHER COSTS INTENDED TO |
---|
315 | 311 | | 10 |
---|
316 | 312 | | INFLUENCE LEGISLATION OR BALLOT MEASURES AT THE LOCAL , STATE, OR11 |
---|
317 | 313 | | FEDERAL LEVEL;12 |
---|
318 | 314 | | (e) T |
---|
319 | 315 | | RAVEL, LODGING, FOOD, OR BEVERAGE EXPENSES FOR THE |
---|
320 | 316 | | 13 |
---|
321 | 317 | | HOSPITAL'S BOARD OF DIRECTORS AND OFFICERS; AND14 |
---|
322 | 318 | | (f) G |
---|
323 | 319 | | IFTS OR ENTERTAINMENT EXPENSES . |
---|
324 | 320 | | 15 |
---|
325 | 321 | | (3) Enforcement - penalties. (a) T HE ATTORNEY GENERAL MAY16 |
---|
326 | 322 | | INVESTIGATE A COMPLAINT CONCERNING A VIOLATION OF THIS ARTICLE17 |
---|
327 | 323 | | 29. |
---|
328 | 324 | | A PERSON THAT VIOLATES THIS ARTICLE 29 RISKS THE PUBLIC'S |
---|
329 | 325 | | 18 |
---|
330 | 326 | | HEALTH AND ENGAGES IN AN UNFAIR OR DECEPTIVE TRADE PRACTICE19 |
---|
331 | 327 | | PURSUANT TO SECTION 6-1-105 (1)(iiii) AND IS SUBJECT TO THE20 |
---|
332 | 328 | | ENFORCEMENT PROVISIONS , CIVIL PENALTIES, AND DAMAGES SET FORTH21 |
---|
333 | 329 | | IN ARTICLE 1 OF THIS TITLE 6.22 |
---|
334 | 330 | | (b) E |
---|
335 | 331 | | ACH PACKAGE OF A 340B DRUG THAT CONSTITUTES A23 |
---|
336 | 332 | | PROHIBITED ACT UNDER THIS ARTICLE 29 CONSTITUTES A SEPARATE24 |
---|
337 | 333 | | VIOLATION OF SUBSECTION (1) OF THIS SECTION.25 |
---|
338 | 334 | | (c) L |
---|
339 | 335 | | IMITED DISTRIBUTION OF A DRUG REQUIRED UNDER 21 U.S.C.26 |
---|
340 | 336 | | SEC. 355-1 DOES NOT CONSTITUTE A VIOLATION OF THIS ARTICLE 29.27 |
---|
341 | 337 | | 071 |
---|
342 | 338 | | -9- (d) A PERSON REGULATED BY THE STATE BOARD OF PHARMACY1 |
---|
343 | 339 | | CREATED IN SECTION 12-280-104 MAY BE SUBJECT TO DISCIPLINE2 |
---|
344 | 340 | | PURSUANT TO SECTION 12-280-108 (1)(c), (1)(d), OR (1)(i) FOR VIOLATING3 |
---|
345 | 341 | | THIS ARTICLE 29.4 |
---|
346 | 342 | | (4) Nonpreemption. N OTHING IN THIS ARTICLE 29 SHALL BE5 |
---|
347 | 343 | | CONSTRUED OR APPLIED TO BE LESS RESTRICTIVE THAN ANY FEDERAL LAW6 |
---|
348 | 344 | | APPLYING TO PERSONS REGULATED BY THIS SECTION . NOTHING IN THIS7 |
---|
349 | 345 | | SECTION SHALL BE CONSTRUED OR APPLIED TO BE IN CONFLICT WITH ANY8 |
---|
350 | 346 | | OF THE FOLLOWING:9 |
---|
351 | 347 | | (a) A |
---|
352 | 348 | | PPLICABLE FEDERAL LAW AND RELATED REGULATIONS ; OR10 |
---|
353 | 349 | | (b) O |
---|
354 | 350 | | THER LAWS OF THIS STATE, IF THE LAWS ARE COMPATIBLE11 |
---|
355 | 351 | | WITH APPLICABLE FEDERAL LAW .12 |
---|
356 | 352 | | (5) |
---|
357 | 353 | | Data exclusions. S UBSECTION (1) OF THIS SECTION DOES NOT13 |
---|
358 | 354 | | PROHIBIT A MANUFACTURER FROM REQUIRING HEALTH INFORMATION OR14 |
---|
359 | 355 | | OTHER DATA THAT A COVERED ENTITY IS REQUIRED TO FURNISH TO THE15 |
---|
360 | 356 | | MANUFACTURER UNDER APPLICABLE FEDERAL LAW , INCLUDING DATA16 |
---|
361 | 357 | | RELATING TO AN AUDIT IN ACCORDANCE WITH PROCEDURES ESTABLISHED17 |
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362 | 358 | | BY THE FEDERAL DEPARTMENT OF HEALTH AND HUMAN SERVICES UNDER18 |
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363 | 359 | | 42 |
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364 | 360 | | U.S.C. SEC. 256b (a)(5)(C).19 |
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365 | 361 | | SECTION 3. In Colorado Revised Statutes, add 25-3-132 as20 |
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366 | 362 | | follows:21 |
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367 | 363 | | 25-3-132. 340B drug pricing program transparency -22 |
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368 | 364 | | definitions. (1) A |
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369 | 365 | | S USED IN THIS SECTION:23 |
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370 | 366 | | (a) "340B |
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371 | 367 | | DRUG PRICING PROGRAM" OR "340B PROGRAM" MEANS24 |
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372 | 368 | | THE PROGRAM DESCRIBED IN 42 U.S.C. SEC. 256b (a)(1).25 |
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373 | 369 | | (b) "340B |
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374 | 370 | | SAVINGS" MEANS THE DIFFERENCE BETWEEN THE |
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375 | 371 | | 26 |
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376 | 372 | | AGGREGATED MARKET RATE COSTS AND THE AGGREGATED ACQUISITION27 |
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377 | 373 | | 071 |
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378 | 374 | | -10- COSTS FOR 340B DRUGS.1 |
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379 | 375 | | (c) "HOSPITAL COVERED ENTITY" MEANS A HOSPITAL LICENSED OR2 |
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380 | 376 | | CERTIFIED BY THE DEPARTMENT PURSUANT TO THE DEPARTMENT 'S3 |
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381 | 377 | | AUTHORITY UNDER SECTION 25-1.5-103 (1)(a) AND THAT IS A "COVERED4 |
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382 | 378 | | ENTITY" AS DEFINED IN 42 U.S.C. SEC. 256b (a)(4).5 |
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383 | 379 | | (2) E |
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384 | 380 | | XCEPT AS PROVIDED IN SUBSECTION (3) OF THIS SECTION,6 |
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385 | 381 | | EACH HOSPITAL COVERED ENTITY THAT IS A REPORTING HOSPITAL , AS |
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386 | 382 | | 7 |
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387 | 383 | | DEFINED IN SECTION 25.5-1-701, SHALL INCLUDE THE FOLLOWING8 |
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388 | 384 | | INFORMATION IN THE ANNUAL REPORT SUBMITTED PURSUANT TO SECTION9 |
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389 | 385 | | 25.5-1-703 |
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390 | 386 | | (3): |
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391 | 387 | | 10 |
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392 | 388 | | (a) T |
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393 | 389 | | HE ANNUAL, REPORTED 340B SAVINGS TO |
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394 | 390 | | THE HOSPITAL11 |
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395 | 391 | | COVERED ENTITY RESULTING FROM ITS ABILITY TO ACQUIRE12 |
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396 | 392 | | PHARMACEUTICALS AT A DISCOUNT THROUGH THE 340B DRUG PRICING13 |
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397 | 393 | | PROGRAM;14 |
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398 | 394 | | (b) A |
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399 | 395 | | DESCRIPTION OF HOW THE HOSPITAL COVERED ENTITY USES15 |
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400 | 396 | | SAVINGS FROM PARTICIPATION IN THE 340B PROGRAM; |
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401 | 397 | | 16 |
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402 | 398 | | (c) T |
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403 | 399 | | HE AGGREGATED MARKET RATE COSTS AND THE AGGREGATED |
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404 | 400 | | 17 |
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405 | 401 | | ACQUISITION COSTS FOR 340B DRUGS USED TO CALCULATE 340B SAVINGS;18 |
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406 | 402 | | AND19 |
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407 | 403 | | (d) T |
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408 | 404 | | HE TOTAL OPERATING COSTS OF THE HOSPITAL COVERED |
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409 | 405 | | 20 |
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410 | 406 | | ENTITY AND COSTS RELATING TO PROVIDING CHARITY CARE .21 |
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411 | 407 | | (3) N |
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412 | 408 | | OTHING IN THIS SECTION REQUIRES THE PUBLIC DISCLOSURE22 |
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413 | 409 | | OF RECORDS THAT ARE PUBLIC RECORDS UNDER THE "COLORADO OPEN23 |
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414 | 410 | | R |
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415 | 411 | | ECORDS ACT", PART 2 OF ARTICLE 72 OF TITLE 24, BUT THAT ARE24 |
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416 | 412 | | EXEMPTED FROM DISCLOSURE UNDER THAT ACT .25 |
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417 | 413 | | SECTION 4. Severability. If any provision of this act or the26 |
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418 | 414 | | application thereof to any person or circumstance is held invalid, such27 |
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419 | 415 | | 071 |
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420 | 416 | | -11- invalidity does not affect other provisions or applications of the act that1 |
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421 | 417 | | can be given effect without the invalid provision or application, and to2 |
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422 | 418 | | this end the provisions of this act are declared to be severable.3 |
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423 | 419 | | SECTION 5. Act subject to petition - effective date. This act4 |
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424 | 420 | | takes effect at 12:01 a.m. on the day following the expiration of the5 |
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425 | 421 | | ninety-day period after final adjournment of the general assembly; except6 |
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426 | 422 | | that, if a referendum petition is filed pursuant to section 1 (3) of article V7 |
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427 | 423 | | of the state constitution against this act or an item, section, or part of this8 |
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428 | 424 | | act within such period, then the act, item, section, or part will not take9 |
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429 | 425 | | effect unless approved by the people at the general election to be held in10 |
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430 | 426 | | November 2026 and, in such case, will take effect on the date of the11 |
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431 | 427 | | official declaration of the vote thereon by the governor.12 |
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432 | 428 | | 071 |
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433 | 429 | | -12- |
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