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28 | 28 | | STATE OF OKLAHOMA |
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29 | 29 | | |
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30 | 30 | | 2nd Session of the 58th Legislature (2022) |
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31 | 31 | | |
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32 | 32 | | HOUSE BILL 3492 By: McEntire |
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33 | 33 | | |
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34 | 34 | | |
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35 | 35 | | |
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36 | 36 | | |
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37 | 37 | | |
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38 | 38 | | AS INTRODUCED |
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39 | 39 | | |
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40 | 40 | | An Act relating to healthcare; creating the Oklahoma |
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41 | 41 | | Rebate Pass Through and PBM Meaningful Transparency |
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42 | 42 | | Act of 2022; amending 59 O.S. 2021, Sections 357 and |
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43 | 43 | | 358, which relate to definitions; modifying |
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44 | 44 | | definitions; creating duties; creating licensing |
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45 | 45 | | application requirements; amending 36 O.S. 2021, |
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46 | 46 | | Section 6960, which relates to definitions; defining |
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47 | 47 | | terms; creating PBM disclosures; amending 36 O.S. |
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48 | 48 | | 2021, Section 6962, which relates to pharmacy |
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49 | 49 | | benefits manager compliance; creating duties; |
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50 | 50 | | amending 36 O.S. 2021, Section 6964, which relates to |
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51 | 51 | | a formulary for prescription drugs; creating agency |
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52 | 52 | | duties; creating PBM fairness in cost sharing; |
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53 | 53 | | creating penalties; creating insurer fairness in cost |
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54 | 54 | | sharing; providing for noncodification; providing for |
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55 | 55 | | codification; and providing an effecti ve date. |
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56 | 56 | | |
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57 | 57 | | |
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58 | 58 | | |
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59 | 59 | | |
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60 | 60 | | BE IT ENACTED BY THE PEOP LE OF THE STATE OF OKLAHOMA : |
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61 | 61 | | SECTION 1. NEW LAW A new section of law not to b e |
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62 | 62 | | codified in the Oklahoma Statutes reads as follows: |
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63 | 63 | | This act shall be known and may be cited as the "Oklahoma Rebate |
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64 | 64 | | Pass Through and PBM Meaningful Transparency Act of 2022 ". |
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65 | 65 | | SECTION 2. AMENDATORY 59 O.S. 2021, Section 357, is |
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66 | 66 | | amended to read as fo llows: |
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67 | 67 | | Section 357. As used in this act: |
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68 | 68 | | |
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93 | 93 | | |
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94 | 94 | | 1. "Covered entity" means a nonprofit hospital or medical |
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95 | 95 | | service organization, insurer, heal th coverage plan or health |
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96 | 96 | | maintenance organization; a health program administered by the state |
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97 | 97 | | in the capacity of pro vider of health coverage; or an employer, |
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98 | 98 | | labor union, or other entity organized in the state that provides |
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99 | 99 | | health coverage to covered ind ividuals who are employed o r reside in |
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100 | 100 | | the state. This term does not include a health plan that provides |
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101 | 101 | | coverage only for accidental injury, specified disease, hospital |
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102 | 102 | | indemnity, disability income, or other limited benefit he alth |
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103 | 103 | | insurance policies and contracts that do not inclu de prescription |
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104 | 104 | | drug coverage; |
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105 | 105 | | 2. "Covered individual" means a member, participant, enroll ee, |
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106 | 106 | | contract holder or policy holder or beneficiary of a covered entity |
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107 | 107 | | who is provided health coverage by the covered entity. A covered |
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108 | 108 | | individual includes any dep endent or other person provided health |
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109 | 109 | | coverage through a policy, contract or plan for a co vered |
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110 | 110 | | individual; |
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111 | 111 | | 3. "Department" means the Oklahoma Insurance Department; |
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112 | 112 | | 4. "Maximum allowable cost " or "MAC" means the list of drug |
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113 | 113 | | products delineating the max imum per-unit reimbursement for |
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114 | 114 | | multiple-source prescription drugs, medical product or devi ce; |
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115 | 115 | | 5. "Multisource drug product reimbursement " (reimbursement) |
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116 | 116 | | means the total amount paid to a pharmacy inc lusive of any reduction |
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117 | 117 | | in payment to the pharmacy, exc luding prescription dispense fees; |
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143 | 143 | | |
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144 | 144 | | 6. "Pharmacy benefits management " means a service provi ded to |
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145 | 145 | | covered entities to facilitate the provision of prescription drug |
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146 | 146 | | benefits to covered individuals withi n the state, including |
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147 | 147 | | negotiating pricing and other te rms with drug manufacturers and |
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148 | 148 | | providers. Pharmacy benefits management may include any or all of |
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149 | 149 | | the following services: |
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150 | 150 | | a. claims processing, performance of drug-utilization |
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151 | 151 | | review, processing of dr ug prior authorization |
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152 | 152 | | requests, retail network managem ent and payment of |
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153 | 153 | | claims to pharmacies for prescription drugs dispensed |
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154 | 154 | | to covered individuals, |
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155 | 155 | | b. clinical formulary development and management |
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156 | 156 | | services, |
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157 | 157 | | c. rebate contracting an d administration, |
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158 | 158 | | d. certain patient compliance, therapeutic intervention |
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159 | 159 | | and generic substitution programs, or |
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160 | 160 | | e. disease management programs , |
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161 | 161 | | f. adjudication of appeals and grievances related to the |
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162 | 162 | | prescription drug benefit, and/or |
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163 | 163 | | g. controlling the cost of prescription drugs; |
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164 | 164 | | 7. "Pharmacy benefits manager" or "PBM" means a person, |
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165 | 165 | | business or other entity that, either directly or through an |
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166 | 166 | | intermediary, performs pharmacy benefits management. The term |
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167 | 167 | | includes a person or entity acting for a PBM in a contractual or |
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193 | 193 | | |
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194 | 194 | | employment relationship in the pe rformance of pharmacy benef its |
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195 | 195 | | management for a managed care company, nonprofit hospital, medical |
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196 | 196 | | service organization, insurance company, third-party payor, or a |
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197 | 197 | | health program administered by an agency of this state; |
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198 | 198 | | 8. "Plan sponsor" means the employers, insurance companies, |
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199 | 199 | | unions and health maintenance organizations or any other entity |
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200 | 200 | | responsible for establishing, maintaining, or administering a health |
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201 | 201 | | benefit plan on behalf of covered individuals; and |
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202 | 202 | | 9. "Provider" means a pharmacy licensed by the State Board of |
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203 | 203 | | Pharmacy, or an agent or representative of a pharmacy, including, |
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204 | 204 | | but not limited to, the pharmacy 's contracting agent, which |
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205 | 205 | | dispenses prescription drugs or devices to covered individuals. |
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206 | 206 | | SECTION 3. AMENDATORY 59 O.S. 2021, Section 358, is |
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207 | 207 | | amended to read as follows: |
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208 | 208 | | Section 358. A. In order to provide pharmacy benefits |
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209 | 209 | | management or any of the services included under the defi nition of |
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210 | 210 | | pharmacy benefits management in this state, a pharma cy benefits |
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211 | 211 | | manager or any entity acting as one in a co ntractual or employment |
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212 | 212 | | relationship for a covered entity shall first obtain a license from |
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213 | 213 | | the Oklahoma Insurance Department, and the Depa rtment may charge a |
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214 | 214 | | fee for such licensure. |
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215 | 215 | | B. The Department shall establish, by regulat ion, licensure |
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216 | 216 | | procedures, required disclosures for pharmacy benefits managers |
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217 | 217 | | (PBMs) and other rules as may be necessar y for carrying out and |
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244 | 244 | | enforcing the provision s of this act. The licensure procedures |
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245 | 245 | | shall, at a minimum, include the completion of an application form |
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246 | 246 | | that shall include the name and address of an agent for service of |
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247 | 247 | | process, the payment of a requisite fee, and evidence of the |
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248 | 248 | | procurement of a sur ety bond the following: |
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249 | 249 | | 1. The name, address, and telephone contact number of the PBM; |
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250 | 250 | | 2. The name and address of the PBM's agent for service of |
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251 | 251 | | process in the state; |
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252 | 252 | | 3. The name and address of each person wit h management or |
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253 | 253 | | control over the PBM; |
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254 | 254 | | 4. Evidence of the procurement of a surety bon d; |
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255 | 255 | | 5. The name and address of each person with a beneficial |
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256 | 256 | | ownership interest in the PBMs; |
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257 | 257 | | 6. In the case of a PBM applicant that is a partnership or |
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258 | 258 | | other unincorporated association, limited liability corporation o r |
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259 | 259 | | corporation, and has five or more partners, members, or |
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260 | 260 | | stockholders: |
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261 | 261 | | a. the applicant shall specify its legal structure and |
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262 | 262 | | the total number of partners, members, or |
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263 | 263 | | stockholders, |
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264 | 264 | | b. the applicant shall specify the name, address, usual |
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265 | 265 | | occupation, and professional qualifications of the |
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266 | 266 | | five partners, members , or stockholders with the five |
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267 | 267 | | largest ownership interests in the PBM, and |
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268 | 268 | | |
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294 | 294 | | c. the applicant shall agree that, upon request by the |
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295 | 295 | | Department, it shall furnish the Department with |
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296 | 296 | | information regarding the name, address, usual |
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297 | 297 | | occupation, and professional qualifications of any |
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298 | 298 | | other partners, members, or stockhol ders; and |
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299 | 299 | | 7. A signed statement indicating that the PBM has not been |
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300 | 300 | | convicted of a felony and has not violated any of the requireme nts |
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301 | 301 | | of the Oklahoma Pharmacy Act and the Patient 's Right to Pharmacy |
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302 | 302 | | Choice Act, or, if the ap plicant cannot provide such a statement, a |
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303 | 303 | | signed statement describing the relevant convi ction(s) or |
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304 | 304 | | violation(s). |
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305 | 305 | | C. The Department may subpoena witnesses and informa tion. Its |
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306 | 306 | | compliance officers may take and copy records for i nvestigative use |
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307 | 307 | | and prosecutions. Nothing in this subsection shall limit the Offic e |
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308 | 308 | | of the Attorney General from using its investi gative demand |
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309 | 309 | | authority to investigate and prosecute violation s of the law. |
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310 | 310 | | D. The Department may suspend, revoke or refuse to issue or |
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311 | 311 | | renew a license for noncompliance with any of the provisions hereby |
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312 | 312 | | established or with the rules promulgated by the D epartment; for |
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313 | 313 | | conduct likely to mislead, deceive or defraud th e public or the |
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314 | 314 | | Department; for unfair or deceptive business p ractices or for |
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315 | 315 | | nonpayment of a renewal fee or fine . The Department may also levy |
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316 | 316 | | administrative fines for each count of which a PBM has been |
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317 | 317 | | convicted in a Department hearing. |
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318 | 318 | | |
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343 | 343 | | |
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344 | 344 | | SECTION 4. AMENDATORY 36 O.S. 2021, Section 6960, is |
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345 | 345 | | amended to read as follows : |
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346 | 346 | | Section 6960. For purposes of the Patient's Right to Pharmacy |
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347 | 347 | | Choice Act: |
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348 | 348 | | 1. "Administrative fees" means fees or payments from |
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349 | 349 | | pharmaceutical manufacturers to, or otherwise retained by, a |
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350 | 350 | | pharmacy benefits manager (PBM) or its designee pursuant to a |
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351 | 351 | | contract between a PBM or a ffiliate and the manufacturer in |
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352 | 352 | | connection with the PBM's administering, invoicing, alloc ating and |
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353 | 353 | | collecting the rebates; |
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354 | 354 | | 2. "Aggregate-retained rebate percentage" means the percentage |
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355 | 355 | | of all rebates received by a PBM from all pharmaceutical |
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356 | 356 | | manufacturers which is not passed on to the PBM's health plan or |
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357 | 357 | | health insurer clients. Aggregate-retained rebate percentage shall |
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358 | 358 | | be expressed without disclosing any identifying information |
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359 | 359 | | regarding any health pla n, prescription drug, or the rapeutic class, |
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360 | 360 | | and shall be calculated by dividi ng: |
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361 | 361 | | a. the aggregate dollar amount of all rebates that the |
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362 | 362 | | PBM received during t he prior calendar year from all |
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363 | 363 | | pharmaceutical manufacturers and did not pass through |
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364 | 364 | | to the PBM's health plan or health in surer clients, by |
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365 | 365 | | b. the aggregate dollar amount of all rebates that the |
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366 | 366 | | pharmacy benefits manager received duri ng the prior |
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367 | 367 | | calendar year from all pharmaceutical manufacturers; |
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368 | 368 | | |
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393 | 393 | | |
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394 | 394 | | 3. "Defined cost sharing" means a deductible payment or |
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395 | 395 | | coinsurance amount impo sed on an enrollee for a cover ed prescription |
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396 | 396 | | drug under the enrol lee's health plan; |
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397 | 397 | | 4. "Formulary" means a list of prescription drugs , as well as |
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398 | 398 | | accompanying tiering and other coverage information, that has been |
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399 | 399 | | developed by an issuer, a health plan, or t he designee of a health |
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400 | 400 | | insurer or health plan, which the health insurer, health plan, or |
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401 | 401 | | designee of the health insurer or health plan references in |
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402 | 402 | | determining applicable coverage and benefit levels; |
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403 | 403 | | 5. "Generic equivalent" means a drug that is designate d to be |
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404 | 404 | | therapeutically equivalent, as indicated by the United States Food |
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405 | 405 | | and Drug Administration's "Approved Drug Products with Therapeutic |
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406 | 406 | | Equivalence Evaluatio ns"; provided, however, that a drug shall not |
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407 | 407 | | be considered a generic equivalent until the drug becomes nationally |
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408 | 408 | | available; |
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409 | 409 | | 6. "Health insurer" means any corporation, associa tion, benefit |
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410 | 410 | | society, exchange, partnership or individual licensed by the |
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411 | 411 | | Oklahoma Insurance Code; |
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412 | 412 | | 7. "Health insurer administrative service fees" means fees or |
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413 | 413 | | payments from a health insurer or a designee of the health insurer |
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414 | 414 | | to, or otherwise retained by, a PBM or its design ee pursuant to a |
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415 | 415 | | contract between a PBM or affiliate, and the health insurer or |
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416 | 416 | | designee of the health insurer in connec tion with the PBM managing |
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443 | 443 | | or administering the pharmacy benefit and administering, invoicin g, |
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444 | 444 | | allocating and collecting rebates; |
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445 | 445 | | 8. "Health plan" means a policy, contract, certification, or |
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446 | 446 | | agreement offered or issued by a health insurer to provide, deli ver, |
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447 | 447 | | arrange for, pay for , or reimburse any of the costs of health |
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448 | 448 | | services; |
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449 | 449 | | 2. 9. "Mail-order pharmacy" means a pharmacy licensed by t his |
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450 | 450 | | state that primarily dispenses and delivers covered drugs via common |
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451 | 451 | | carrier; |
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452 | 452 | | 3. 10. "Pharmacy benefits manager " or "PBM" means a person |
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453 | 453 | | that, either directly or through a n intermediary, performs pharmacy |
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454 | 454 | | benefits management, as defined in paragraph 6 of Section 357 of |
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455 | 455 | | Title 59 of the Oklahoma Statutes and any other person acting for |
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456 | 456 | | such person under a contractual or employment relationship in th e |
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457 | 457 | | performance of pharmacy benefits management for a managed -care |
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458 | 458 | | company, nonprofit hospital, m edical service organization, insurance |
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459 | 459 | | company, third-party payor or a health program administered by a |
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460 | 460 | | department of this state; |
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461 | 461 | | 4. 11. "Pharmacy and therapeut ics committee" or "P&T committee" |
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462 | 462 | | means a committee at a hospit al or a health insurance plan th at |
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463 | 463 | | decides which drugs will appear on that entity 's drug formulary; |
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464 | 464 | | 12. "Price-protection rebate" means a negotiated-price |
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465 | 465 | | concession that accrues directly or indirectly to the health |
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466 | 466 | | insurer, or other party on behalf of the health insurer, in the |
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492 | 492 | | |
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493 | 493 | | event of an increase in the wholesale acquisition of a drug above a |
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494 | 494 | | specified threshold; |
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495 | 495 | | 13. "Rebates" means: |
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496 | 496 | | a. negotiated-price concessions including, but not |
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497 | 497 | | limited to, base-price concessions (whether described |
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498 | 498 | | as a rebate or otherwise) and reasonable estima tes of |
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499 | 499 | | any price-protection rebates and performance -based |
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500 | 500 | | price concessions that may accrue directly or |
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501 | 501 | | indirectly to the PBM during the coverage year from a |
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502 | 502 | | manufacturer, dispensing pharmacy, or other party in |
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503 | 503 | | connection with the dispensing or administrat ion of a |
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504 | 504 | | prescription drug, and |
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505 | 505 | | b. reasonable estimates of any price concessions, fees , |
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506 | 506 | | and other administrative costs that are pass ed |
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507 | 507 | | through, or are reasonably anticipated to be passed |
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508 | 508 | | through, to the PBM and serve to redu ce the PBM's |
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509 | 509 | | liabilities for a pr escription drug; |
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510 | 510 | | 5. 14. "Retail pharmacy network " means retail pharmacy |
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511 | 511 | | providers contracted with a PBM in which the pharmacy prim arily |
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512 | 512 | | fills and sells prescri ptions via a retail, storefront location; |
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513 | 513 | | 6. 15. "Rural service area" means a five-digit ZIP code in |
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514 | 514 | | which the population density is less than one thousand (1,0 00) |
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515 | 515 | | individuals per square mile; |
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516 | 516 | | |
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541 | 541 | | |
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542 | 542 | | 7. 16. "Suburban service area " means a five-digit ZIP code in |
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543 | 543 | | which the population de nsity is between one thousand (1,000) a nd |
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544 | 544 | | three thousand (3,000) individu als per square mile; and |
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545 | 545 | | 8. 17. "Urban service area" means a five-digit ZIP code in |
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546 | 546 | | which the population density is greater than three thousand (3,000) |
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547 | 547 | | individuals per square mile. |
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548 | 548 | | SECTION 5. NEW LAW A new section of law to be codi fied |
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549 | 549 | | in the Oklahoma Statutes as Section 6962.1 of Title 36, unless there |
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550 | 550 | | is created a duplication in numbering, reads as follows : |
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551 | 551 | | A. Beginning on January 1, 2022, and on an annual basi s |
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552 | 552 | | thereafter, a pharmacy benefits ma nager (PBM) shall provide the |
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553 | 553 | | Insurance Department with a report containing the following |
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554 | 554 | | information from the prior calendar year as it pertai ns to pharmacy |
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555 | 555 | | benefits provided by health insurer s to enrollees in the state: |
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556 | 556 | | 1. The aggregate dollar amount of all rebates that the PBM |
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557 | 557 | | received from all phar maceutical manufacturers; |
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558 | 558 | | 2. The aggregate dollar amount of al l administrative fees that |
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559 | 559 | | the PBM received; |
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560 | 560 | | 3. The aggregate dollar amount of al l issuer administrative |
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561 | 561 | | service fees that the PBM received; |
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562 | 562 | | 4. The aggregate dollar amount of all rebates that the PBM |
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563 | 563 | | received from all pharmaceutical manufacturers and did not pass |
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564 | 564 | | through to health plans or he alth insurers; |
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565 | 565 | | |
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590 | 590 | | |
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591 | 591 | | 5. The aggregate dollar amo unt of all administrative fees that |
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592 | 592 | | the PBM received from all pharmaceutical manufacturers and did not |
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593 | 593 | | pass through to health plans or health insurers; |
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594 | 594 | | 6. The aggregate-retained rebate percentage; and |
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595 | 595 | | 7. Across all of the PBM's contractual or other relationships |
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596 | 596 | | with all health plans or health insurers, the highest aggregate- |
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597 | 597 | | retained rebate percentage, the lowest aggregate -retained rebate |
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598 | 598 | | percentage, and the mean aggregate-retained rebate perc entage. |
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599 | 599 | | B. The Department shall p ublish in a timely manner the |
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600 | 600 | | information that it receives under subsection A of this section on a |
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601 | 601 | | publicly available website ; provided that such information shall be |
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602 | 602 | | made available in a form that does not disclose the identity of a |
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603 | 603 | | specific health plan or the identity of a specific manufacturer, the |
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604 | 604 | | prices charged for specific drugs or classes o f drugs, or the amount |
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605 | 605 | | of any rebates provided for specific drugs or classes of drugs. |
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606 | 606 | | C. The PBM and the Department shall not publish or otherwise |
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607 | 607 | | disclose any information that would reveal the identity of a |
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608 | 608 | | specific health plan, the price(s) charged for a specific drug or |
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609 | 609 | | class of drugs, the amount of any rebates provided for a specific |
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610 | 610 | | drug or class of drugs, the manufacturer, or that would otherw ise |
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611 | 611 | | have the potential to compromise the financial, competitive, o r |
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612 | 612 | | proprietary nature of the information. Any such information shall |
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613 | 613 | | be protected from disclosure as confidential and proprietary |
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614 | 614 | | information, is not a public record as defined in the Oklahoma Open |
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615 | 615 | | |
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640 | 640 | | |
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641 | 641 | | Records Act, Section 24A.1 et seq. of Title 51 of the Oklahoma |
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642 | 642 | | Statutes, and shall not be disclosed directly or indirectly. A PBM |
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643 | 643 | | shall impose the confidential ity protections of this section on any |
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644 | 644 | | vendor or downstream third pa rty that performs health care or |
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645 | 645 | | administrative services on beha lf of the PBM and that may receive or |
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646 | 646 | | have access to rebate info rmation. |
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647 | 647 | | SECTION 6. AMENDATORY 36 O.S. 2021, Section 6962, is |
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648 | 648 | | amended to read as follows : |
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649 | 649 | | Section 6962. A. The Oklahoma Insurance Departme nt shall |
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650 | 650 | | review and approve retail pharmacy network access for all pharmacy |
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651 | 651 | | benefits managers (PBMs) to ensure compliance with Se ction 4 6961 of |
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652 | 652 | | this act title. |
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653 | 653 | | B. A PBM, or an agent of a PBM, shall n ot: |
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654 | 654 | | 1. Cause or knowingly permit the us e of advertisement, |
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655 | 655 | | promotion, solicitation , representation, proposal or offer that is |
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656 | 656 | | untrue, deceptive or misleading; |
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657 | 657 | | 2. Charge a pharmacist or pharmacy a fee related to the |
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658 | 658 | | adjudication of a claim, including with out limitation a fee for: |
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659 | 659 | | a. the submission of a claim, |
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660 | 660 | | b. enrollment or participat ion in a retail pharmacy |
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661 | 661 | | network, or |
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662 | 662 | | c. the development or manag ement of claims processing |
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663 | 663 | | services or claims payment services related to |
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664 | 664 | | participation in a retail pharmacy network; |
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665 | 665 | | |
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690 | 690 | | |
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691 | 691 | | 3. Reimburse a pharmacy or pha rmacist in the state an amount |
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692 | 692 | | less than the amount that the PBM reimburses a pharmacy owned by or |
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693 | 693 | | under common ownership with a PBM for providi ng the same covered |
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694 | 694 | | services. The reimbursement amount paid to the phar macy shall be |
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695 | 695 | | equal to the reimbursement amount calculated on a per-unit basis |
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696 | 696 | | using the same generic product identifier or generic code number |
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697 | 697 | | paid to the PBM-owned or PBM-affiliated pharmacy; |
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698 | 698 | | 4. Deny a pharmacy the oppo rtunity to participate in any |
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699 | 699 | | pharmacy network at preferred participation status if the pharmacy |
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700 | 700 | | is willing to accept the terms and conditions that the PBM has |
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701 | 701 | | established for other pharmacies as a condition of preferr ed network |
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702 | 702 | | participation status; |
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703 | 703 | | 5. Deny, limit or terminate a pharmacy 's contract based on |
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704 | 704 | | employment status of any employee who has an active license to |
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705 | 705 | | dispense, despite probation status, with the State Board of |
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706 | 706 | | Pharmacy; |
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707 | 707 | | 6. Retroactively deny or redu ce reimbursement for a covered |
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708 | 708 | | service claim after returning a paid clai m response as part of the |
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709 | 709 | | adjudication of the claim, unless: |
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710 | 710 | | a. the original claim was submitted fraudulently, or |
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711 | 711 | | b. to correct errors identified i n an audit, so long as |
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712 | 712 | | the audit was conducted in compliance with Sections |
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713 | 713 | | 356.2 and 356.3 of Title 59 of the Oklahoma Statutes; |
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714 | 714 | | or |
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715 | 715 | | |
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740 | 740 | | |
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741 | 741 | | 7. Fail to make any payment due to a pharmacy or pharmacist for |
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742 | 742 | | covered services properly rendered in the event a PBM termi nates a |
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743 | 743 | | pharmacy or pharmacist from a pharmacy benefits manager network ; or |
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744 | 744 | | 8. Contractually prohibit or penalize a pharmacy or pharmacist |
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745 | 745 | | for: |
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746 | 746 | | a. disclosing to an individual information rega rding the |
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747 | 747 | | existence and clinical efficacy of a generic |
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748 | 748 | | equivalent that would be less expensive to the |
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749 | 749 | | enrollee, |
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750 | 750 | | (1) under his or her health pla n prescription drug |
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751 | 751 | | benefit, or |
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752 | 752 | | (2) outside his or her health plan pres cription drug |
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753 | 753 | | benefit, without requesting any health plan |
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754 | 754 | | reimbursement, |
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755 | 755 | | than the drug that was original ly prescribed, or |
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756 | 756 | | b. selling to an individual, instead of a particular |
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757 | 757 | | prescribed drug, a therapeutically equivalent drug |
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758 | 758 | | that would be less expensive t o the enrollee, |
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759 | 759 | | (1) under his or her hea lth plan prescription drug |
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760 | 760 | | benefit, or |
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761 | 761 | | (2) outside his or her h ealth plan prescription drug |
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762 | 762 | | benefit, without requesting any health plan |
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763 | 763 | | reimbursement, |
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764 | 764 | | than the drug that was originally prescribed . |
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765 | 765 | | |
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790 | 790 | | |
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791 | 791 | | C. The prohibitions under this section shall apply to con tracts |
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792 | 792 | | between pharmacy benefits managers and pharmacists or pha rmacies for |
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793 | 793 | | participation in retail phar macy networks. |
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794 | 794 | | 1. A PBM contract shall: |
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795 | 795 | | a. not restrict, directly or indirectly, any pharmacy |
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796 | 796 | | that dispenses a prescription drug from informing, or |
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797 | 797 | | penalize such pharmacy for informing, an individual of |
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798 | 798 | | any differential between the individual 's out-of- |
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799 | 799 | | pocket cost or coverage with respect to acqu isition of |
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800 | 800 | | the drug and the amount an individual would pay to |
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801 | 801 | | purchase the drug directly, and |
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802 | 802 | | b. ensure that any entity that provides pharmacy benefits |
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803 | 803 | | management services und er a contract with any such |
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804 | 804 | | health plan or health insurance coverage does not, |
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805 | 805 | | with respect to such plan or coverage, restrict, |
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806 | 806 | | directly or indirectly, a pharmacy that dispenses a |
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807 | 807 | | prescription drug from informing, or penalize such |
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808 | 808 | | pharmacy for informing, a covered individual of any |
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809 | 809 | | differential between the individual 's out-of-pocket |
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810 | 810 | | cost under the plan or coverage with respect to |
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811 | 811 | | acquisition of the drug an d the amount an individual |
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812 | 812 | | would pay for acquisition of the drug without using |
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813 | 813 | | any health plan or healt h insurance coverage. |
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814 | 814 | | |
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839 | 839 | | |
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840 | 840 | | 2. A pharmacy benefits manager's contract with a participa ting |
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841 | 841 | | pharmacist or pharmacy shall not prohibit, restrict or limit |
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842 | 842 | | disclosure of information to the Insurance Co mmissioner, law |
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843 | 843 | | enforcement or state and federal governmental of ficials |
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844 | 844 | | investigating or examining a com plaint or conducting a review of a |
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845 | 845 | | pharmacy benefits manager's compliance with the requirements under |
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846 | 846 | | the Patient's Right to Pharmacy Choice Act. |
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847 | 847 | | 3. A pharmacy benefits manager shall establish and maintain an |
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848 | 848 | | electronic claim inquiry processing system usi ng the National |
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849 | 849 | | Council for Prescription Drug Programs' current standards to |
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850 | 850 | | communicate information to pharmacie s submitting claim inquiries. |
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851 | 851 | | D. For each of the PBM's contracts or other relationships with |
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852 | 852 | | a health plan, a PBM shall publish on an easily a ccessible website |
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853 | 853 | | the health plan formula ry, and timely notification of formulary |
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854 | 854 | | changes and/or product exclusion s. |
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855 | 855 | | SECTION 7. AMENDATORY 36 O.S. 2021, Section 6964, is |
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856 | 856 | | amended to read as fol lows: |
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857 | 857 | | Section 6964. A. A health insurer's insurer or its agent's, |
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858 | 858 | | including pharmacy benefits managers, pharmacy and therapeutics |
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859 | 859 | | committee (P&T committee) shall establish a formulary, which shall |
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860 | 860 | | be a list of prescription drugs, both generic and brand n ame, used |
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861 | 861 | | by practitioners to identif y drugs that offer the greatest overall |
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862 | 862 | | value. |
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863 | 863 | | |
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888 | 888 | | |
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889 | 889 | | B. A health insurer shall prohibit conflicts of interest for |
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890 | 890 | | members of the P&T committee. The P&T committee shall review the |
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891 | 891 | | formulary annually and must meet the followin g requirements: |
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892 | 892 | | 1. A person may not serve on a P&T committee if the person is |
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893 | 893 | | currently employed or was employe d within the preceding year by a |
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894 | 894 | | pharmaceutical manufacturer, developer, labeler , wholesaler or |
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895 | 895 | | distributor. A majority of P&T committee members must be practicing |
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896 | 896 | | physicians, practicing pharmacists, or both, and must be licens ed in |
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897 | 897 | | Oklahoma; |
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898 | 898 | | 2. A health insurer shall require any member of the P&T |
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899 | 899 | | committee to disclose any compensati on or funding from a |
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900 | 900 | | pharmaceutical manufacturer, deve loper, labeler, wholesaler or |
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901 | 901 | | distributor. Such P&T committee member shall be recused from v oting |
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902 | 902 | | on any product manufactured or sold by such pharmaceutical |
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903 | 903 | | manufacturer, developer, labeler, wholesaler or distributor. P&T |
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904 | 904 | | committee members must practice in various clinical specialties that |
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905 | 905 | | adequately represent the needs of health plan enrollees, and there |
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906 | 906 | | must be an adequate number of high -volume specialists and |
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907 | 907 | | specialists treating rare and orphan dise ases; |
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908 | 908 | | 3. The P&T committee must meet no less frequently than on a |
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909 | 909 | | quarterly basis; |
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910 | 910 | | 4. P&T committee formulary development must be conducted |
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911 | 911 | | pursuant to a transparent process, and formulary decisions and |
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912 | 912 | | rationale must be docum ented in writing, with any r ecords and |
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913 | 913 | | |
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938 | 938 | | |
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939 | 939 | | documents relating to the process ava ilable upon request to the |
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940 | 940 | | health plan, subject to the c onditions in subsection C of this |
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941 | 941 | | section. In the case of P&T committee decisions that relate to |
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942 | 942 | | Medicaid managed care orga nizations' prescription drug coverage |
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943 | 943 | | policies, if the P&T committee relies upon any third party to |
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944 | 944 | | provide cost-effectiveness analysis or research, the P&T committee |
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945 | 945 | | must: |
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946 | 946 | | a. disclose to the health benefit plan, the state, and |
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947 | 947 | | the general public the name of the relevant third- |
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948 | 948 | | party, and |
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949 | 949 | | b. provide a process through which patients and providers |
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950 | 950 | | potentially impacted by the third -party's analysis or |
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951 | 951 | | research may provide input to the P&T commit tee; |
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952 | 952 | | 5. Specialists with current clinical expertise who actively |
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953 | 953 | | treat patients in a specifi c therapeutic area, and the specific |
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954 | 954 | | conditions within a therape utic area, must participate in formular y |
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955 | 955 | | decisions regarding each therapeutic area and specific co ndition; |
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956 | 956 | | 6. The P&T committee must base its clinical decisions on the |
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957 | 957 | | strength of scientific evidence, standards of practice, and |
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958 | 958 | | nationally accepted treatme nt guidelines; |
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959 | 959 | | 7. The P&T committee mu st consider whether a particular drug |
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960 | 960 | | has a clinically mean ingful therapeutic advantage over other drugs |
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961 | 961 | | in terms of safety, effectiveness, or clinical o utcome for patient |
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962 | 962 | | populations who may be treated with the drug; |
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963 | 963 | | |
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988 | 988 | | |
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989 | 989 | | 8. The P&T committee must evaluate an d analyze treatment |
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990 | 990 | | protocols and procedures related to the health plan's formulary at |
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991 | 991 | | least annually; |
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992 | 992 | | 9. The P&T committee must review formulary manage ment |
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993 | 993 | | activities, including exceptions and appeals processes, pri or |
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994 | 994 | | authorization, step therapy, quantit y limits, generic subs titutions, |
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995 | 995 | | therapeutic interchange, a nd other drug utilization management |
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996 | 996 | | activities for clinical appropriateness and consistency with |
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997 | 997 | | industry standards and patient and provider organization guidelines; |
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998 | 998 | | 10. The P&T committee must annually review and provide a |
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999 | 999 | | written report to the pharmacy benefits manager on: |
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1000 | 1000 | | a. the percentage of prescription drugs on fo rmulary |
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1001 | 1001 | | subject to each of the types of utilization management |
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1002 | 1002 | | described in paragraph 9 of this subsection, |
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1003 | 1003 | | b. rates of adherence and nonadherence to medicin es by |
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1004 | 1004 | | therapeutic area, |
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1005 | 1005 | | c. rates of abandonment of medicines by therapeutic area, |
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1006 | 1006 | | d. recommendations for improved adherence and reduced |
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1007 | 1007 | | abandonment, |
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1008 | 1008 | | e. recommendations for improvement in f ormulary |
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1009 | 1009 | | management practices consistent with patient , and |
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1010 | 1010 | | provider organization and other clinica l guidelines; provided that |
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1011 | 1011 | | the report shall be subject to the con ditions in subsection C of |
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1012 | 1012 | | this section; |
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1013 | 1013 | | |
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1038 | 1038 | | |
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1039 | 1039 | | 11. The P&T committee must review and make a formu lary decision |
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1040 | 1040 | | on a new U.S. Food and Drug Administration approved drug with in |
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1041 | 1041 | | ninety (90) days of such drug's approval, or must provide a clinical |
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1042 | 1042 | | justification if this timeframe is not met; |
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1043 | 1043 | | 12. The P&T committee must review procedures for medical review |
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1044 | 1044 | | of, and transitioning new plan enrollees to, appropriate formulary |
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1045 | 1045 | | alternatives to ensure that such procedures a ppropriately address |
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1046 | 1046 | | situations involving enrollees stabilized on drugs that are not on |
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1047 | 1047 | | the health plan formulary (or that are on formulary but subject to |
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1048 | 1048 | | prior authorization, step therapy, or other utilization management |
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1049 | 1049 | | requirements). |
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1050 | 1050 | | C. The health insurer, its agents, including pharmacy benefits |
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1051 | 1051 | | managers, and the Department shall not publish or otherwise disclose |
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1052 | 1052 | | any confidential, proprietary information, including , but not |
---|
1053 | 1053 | | limited to, any information that would reveal the identi ty of a |
---|
1054 | 1054 | | specific health plan, the prices charged for a specific drug or |
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1055 | 1055 | | class of drugs, the amount of any rebates provided for a specific |
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1056 | 1056 | | drug or class of drugs, the ma nufacturer, or that would otherwise |
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1057 | 1057 | | have the potential to compromise the financial, co mpetitive, or |
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1058 | 1058 | | proprietary nature of the information. Any such information sha ll |
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1059 | 1059 | | be protected from disclosure as confidential and proprietary |
---|
1060 | 1060 | | information, is not a public record as defined in the Oklahoma Open |
---|
1061 | 1061 | | Records Act, Section 24A.1 et seq. of Title 51 of the Oklaho ma |
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1062 | 1062 | | Statutes, and shall not be disclosed directly or indirectly. A |
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1063 | 1063 | | |
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1064 | 1064 | | Req. No. 8520 Page 22 1 |
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1087 | 1087 | | 24 |
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1088 | 1088 | | |
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1089 | 1089 | | health insurer shall impose the confidentiality protections of this |
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1090 | 1090 | | section on any vendor or downstream third party that performs health |
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1091 | 1091 | | care or administrative services on behalf of the pharmac y benefits |
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1092 | 1092 | | manager that may receive or have access to rebate information. |
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1093 | 1093 | | SECTION 8. NEW LAW A new section of law to be codified |
---|
1094 | 1094 | | in the Oklahoma Statutes as Section 6962.2 of Title 36, unless there |
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1095 | 1095 | | is created a duplication in numbering, reads as follows: |
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1096 | 1096 | | A. An enrollee's defined cost sharin g for each prescription |
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1097 | 1097 | | drug shall be calculated at the point of s ale based on a price that |
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1098 | 1098 | | is reduced by an amount equal to at least eighty-five percent (85%) |
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1099 | 1099 | | of all rebates received, or to be received, in connection with the |
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1100 | 1100 | | dispensing or administration of the prescription drug. |
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1101 | 1101 | | B. For any violation of this section, the Insurance |
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1102 | 1102 | | Commissioner may subject a PBM to an administrative penalty of not |
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1103 | 1103 | | less than One Hundred Dollars ( $100.00) nor more than Five Thousand |
---|
1104 | 1104 | | Dollars ($5,000.00) for each occurrence. Such administrative |
---|
1105 | 1105 | | penalty may be enforced in the same manner in w hich civil judgments |
---|
1106 | 1106 | | may be enforced. |
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1107 | 1107 | | C. Nothing in subsections A and B of this section shall |
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1108 | 1108 | | preclude a PBM from decreasing an enrollee 's defined cost sharing by |
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1109 | 1109 | | an amount greater than that required under subsection A of this |
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1110 | 1110 | | section. |
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1111 | 1111 | | |
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1112 | 1112 | | Req. No. 8520 Page 23 1 |
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1136 | 1136 | | |
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1137 | 1137 | | D. In implementing the requi rements of this section, the state |
---|
1138 | 1138 | | shall only regulate a PBM to the extent permissible under applicable |
---|
1139 | 1139 | | law. |
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1140 | 1140 | | E. In complying with the provisi ons of this section, a PBM or |
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1141 | 1141 | | its agents shall not publish or otherwise reveal information |
---|
1142 | 1142 | | regarding the actual amount of rebates a PBM receives on a product |
---|
1143 | 1143 | | or therapeutic class of products , manufacturer, or pharmacy -specific |
---|
1144 | 1144 | | basis. Such information is p rotected as a trade secret, is not a |
---|
1145 | 1145 | | public record as defined in the Oklahoma Open Records Act, Section |
---|
1146 | 1146 | | 24A.1 et seq. of Title 51 of the Oklahoma Statutes and shall not be |
---|
1147 | 1147 | | disclosed directly or indirectly, or in a manner that would allow |
---|
1148 | 1148 | | for the identification of an indivi dual product, therapeutic class |
---|
1149 | 1149 | | of products, or manufacturer, or in a manner that would have the |
---|
1150 | 1150 | | potential to compromise the financial, compe titive, or proprietary |
---|
1151 | 1151 | | nature of the information. A PBM shall impose the confidentiality |
---|
1152 | 1152 | | protections of this secti on on any vendor or downstream third party |
---|
1153 | 1153 | | that performs health care or administrative services on behalf of |
---|
1154 | 1154 | | the insurer that may receive or have access to rebate information. |
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1155 | 1155 | | SECTION 9. NEW LAW A new section of law to be codified |
---|
1156 | 1156 | | in the Oklahoma Statutes as Section 6970 of Title 36, unless there |
---|
1157 | 1157 | | is created a duplication in numbering, reads a s follows: |
---|
1158 | 1158 | | A. For purposes of this section: |
---|
1159 | 1159 | | |
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1160 | 1160 | | Req. No. 8520 Page 24 1 |
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1183 | 1183 | | 24 |
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1184 | 1184 | | |
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1185 | 1185 | | 1. "Defined cost sharing " means a deductible payment or |
---|
1186 | 1186 | | coinsurance amount imposed on an enrollee for a cove red prescription |
---|
1187 | 1187 | | drug under the enrollee's health plan; |
---|
1188 | 1188 | | 2. "Insurer" means any health insurance issue r that is subject |
---|
1189 | 1189 | | to state law regulating insurance and offers health insuranc e |
---|
1190 | 1190 | | coverage, as defined in 42 U.S.C. , Section 300gg-91, or any state or |
---|
1191 | 1191 | | local governmental employer plan; |
---|
1192 | 1192 | | 3. "Price-protection rebate" means a negotiated price |
---|
1193 | 1193 | | concession that accrues directly or indirectly to the insurer, or |
---|
1194 | 1194 | | other party on behalf of the i nsurer, in the event of an increase in |
---|
1195 | 1195 | | the wholesale acquisition cost of a d rug above a specified |
---|
1196 | 1196 | | threshold; |
---|
1197 | 1197 | | 4. "Rebate" means: |
---|
1198 | 1198 | | a. negotiated price concessions including , but not |
---|
1199 | 1199 | | limited to, base price concessions (whether described |
---|
1200 | 1200 | | as a rebate or otherwise) and reasonable estimates of |
---|
1201 | 1201 | | any price-protection rebates and performance -based |
---|
1202 | 1202 | | price concessions that may accrue directly or |
---|
1203 | 1203 | | indirectly to the insurer during the coverage yea r |
---|
1204 | 1204 | | from a manufacturer, dispensing pharmacy, or other |
---|
1205 | 1205 | | party in connection with the dispensing or |
---|
1206 | 1206 | | administration of a prescription drug, and |
---|
1207 | 1207 | | b. reasonable estimates of any negotiated price |
---|
1208 | 1208 | | concessions, fees, and other administrative costs that |
---|
1209 | 1209 | | |
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1210 | 1210 | | Req. No. 8520 Page 25 1 |
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1233 | 1233 | | 24 |
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1234 | 1234 | | |
---|
1235 | 1235 | | are passed through, or are reasonably anticipated to |
---|
1236 | 1236 | | be passed through, to the insurer and s erve to reduce |
---|
1237 | 1237 | | the insurer's liabilities for a prescription drug. |
---|
1238 | 1238 | | B. An enrollee's defined cost sharing for each prescription |
---|
1239 | 1239 | | drug shall be calculated at the point of sale based on a price that |
---|
1240 | 1240 | | is reduced by an amount equal to a t least eighty-five percent (85%) |
---|
1241 | 1241 | | of all rebates received, or to be received, in connection with the |
---|
1242 | 1242 | | dispensing or administration of the prescription drug. |
---|
1243 | 1243 | | C. For any violation of this section, the Insura nce |
---|
1244 | 1244 | | Commissioner may subjec t an insurer to an administrative penal ty of |
---|
1245 | 1245 | | not less than One Hundred Dollars ($100.00) nor more than Five |
---|
1246 | 1246 | | Thousand Dollars ($5,000.00) for each occurrence. Such |
---|
1247 | 1247 | | administrative penalty may be enforced in the same manner in whic h |
---|
1248 | 1248 | | civil judgments may be en forced. |
---|
1249 | 1249 | | D. Nothing in subsections A through C of this section shall |
---|
1250 | 1250 | | preclude an insurer fro m decreasing an enrollee 's defined cost |
---|
1251 | 1251 | | sharing by an amount greater than that required under subsection B |
---|
1252 | 1252 | | of this section. |
---|
1253 | 1253 | | E. In implementing the requirements of this section, the state |
---|
1254 | 1254 | | shall only regulate an insurer to the extent permissible under |
---|
1255 | 1255 | | applicable law. |
---|
1256 | 1256 | | F. In complying with the provisio ns of this section, an insurer |
---|
1257 | 1257 | | or its agents shall not publish or otherwise reveal informati on |
---|
1258 | 1258 | | regarding the actual amount of rebates an insurer receives on a |
---|
1259 | 1259 | | |
---|
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1283 | 1283 | | 24 |
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1284 | 1284 | | |
---|
1285 | 1285 | | product or therapeutic class of pr oducts, manufacturer, or pharmacy - |
---|
1286 | 1286 | | specific basis. Such information is protected as a trade secret, is |
---|
1287 | 1287 | | not a public record as defined in the Oklahoma Open Records Act, |
---|
1288 | 1288 | | Section 24A.1 et seq. of Title 51 of the Oklahoma St atutes, and |
---|
1289 | 1289 | | shall not be disclosed directly or indirectly, or in a manner that |
---|
1290 | 1290 | | would allow for the identification of an individual pro duct, |
---|
1291 | 1291 | | therapeutic class of product s, or manufacturer, or in a manner that |
---|
1292 | 1292 | | would have the potential to compromise the financial, competitive, |
---|
1293 | 1293 | | or proprietary nature of the information. An insurer shall impose |
---|
1294 | 1294 | | the confidentiality protections of this section on any vendor or |
---|
1295 | 1295 | | downstream third party that performs health care or administrative |
---|
1296 | 1296 | | services on behalf of the insurer and that may receive or have |
---|
1297 | 1297 | | access to rebate information. |
---|
1298 | 1298 | | SECTION 10. This act shall become effective November 1, 2022. |
---|
1299 | 1299 | | |
---|
1300 | 1300 | | 58-2-8520 KN 01/17/22 |
---|