44 | 35 | | |
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45 | 36 | | |
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46 | 37 | | |
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47 | 38 | | An Act relating to health care; creating the Oklahoma |
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48 | 39 | | Rebate Pass-Through and PBM Meaningful Transparency |
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49 | 40 | | Act of 2023; amending 59 O.S. 2021, Sections 357 and |
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50 | 41 | | 358, which relate to definitions; modifying |
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51 | 42 | | definitions, procedures, and penalties; creating |
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52 | 43 | | duties; creating licensing application requirements; |
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53 | 44 | | amending 36 O.S. 2021, Section 6960, as amended by |
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54 | 45 | | Section 1, Chapter 38, O.S.L. 20 22 (36 O.S. Supp. |
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55 | 46 | | 2022, Section 6960), which relates to definitions; |
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56 | 47 | | defining terms; creating PBM disclosures; amending 36 |
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57 | 48 | | O.S. 2021, Section 6962, as amended by Section 2, |
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58 | 49 | | Chapter 38, O.S.L. 2022 (36 O.S. Supp. 2022, Section |
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59 | 50 | | 6962), which relates to pharma cy benefits manager |
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60 | 51 | | compliance; creating duties; amending 36 O.S. 2021, |
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61 | 52 | | Section 6964, which relates to a formulary for |
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62 | 53 | | prescription drugs; creating agency duties; providing |
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63 | 54 | | cost sharing calculation methodo logy, limitations, |
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64 | 55 | | and requirements; creating penalties; clarifying |
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65 | 56 | | authority to take certain actions; prohibiting the |
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66 | 57 | | disclosure of certain informat ion; declaring that |
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67 | 58 | | certain information not be considere d public record; |
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68 | 59 | | providing for noncodification; providing for |
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69 | 60 | | codification; and providing an effecti ve date. |
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70 | 61 | | |
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71 | 62 | | |
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72 | 63 | | |
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107 | 95 | | SECTION 2. AMENDATORY 59 O.S. 2021, Section 357, is |
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108 | 96 | | amended to read as follows: |
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109 | 97 | | Section 357. As used in this act: |
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110 | 98 | | 1. "Covered entity" means a nonprofit hospital or medical |
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111 | 99 | | service organization, insurer, health coverage plan or health |
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112 | 100 | | maintenance organization; a health program administered by the state |
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113 | 101 | | in the capacity of pro vider of health coverage; or an employer, |
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114 | 102 | | labor union, or other entity organized in the state that provides |
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115 | 103 | | health coverage to covered individuals who are employed or reside in |
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116 | 104 | | the state. This term does not include a health pla n that provides |
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117 | 105 | | coverage only for accidental injury, specified diseas e, hospital |
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118 | 106 | | indemnity, disability income, or other li mited benefit health |
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119 | 107 | | insurance policies and contracts that do not include prescription |
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120 | 108 | | drug coverage; |
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121 | 109 | | 2. "Covered individual" means a member, participant, enroll ee, |
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122 | 110 | | contract holder or policy holder or b eneficiary of a covered entity |
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123 | 111 | | who is provided health coverage by the covered entity. A covered |
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124 | 112 | | individual includes any dependent or other person pr ovided health |
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125 | 113 | | coverage through a polic y, contract or plan for a co vered |
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126 | 114 | | individual; |
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158 | 145 | | 5. "Multisource drug product reimbur sement" (reimbursement) |
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159 | 146 | | means the total amount paid t o a pharmacy inclusive of any reduction |
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160 | 147 | | in payment to the pharmacy, excluding prescription dispe nse fees; |
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161 | 148 | | 6. "Pharmacy benefits manag ement" means a service provi ded to |
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162 | 149 | | covered entities to facilitate the provision of prescription drug |
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163 | 150 | | benefits to covered i ndividuals within the state, including |
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164 | 151 | | negotiating pricing and other terms with drug manufacture rs and |
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165 | 152 | | providers. Pharmacy benefits m anagement may include any or all of |
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166 | 153 | | the following services: |
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167 | 154 | | a. claims processing, performance of drug utilization |
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168 | 155 | | review, processing of drug prior authorization |
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169 | 156 | | requests, retail network management and payment of |
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170 | 157 | | claims to pharmacies for prescription drugs dispensed |
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171 | 158 | | to covered individuals, |
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172 | 159 | | b. clinical formulary development a nd management |
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173 | 160 | | services, |
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174 | 161 | | c. rebate contracting an d administration, |
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175 | 162 | | d. certain patient compliance, therapeutic intervention |
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176 | 163 | | and generic substitution pr ograms, or |
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177 | 164 | | e. disease management progr ams, |
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208 | 194 | | 7. "Pharmacy benefits manager" or "PBM" means a person, |
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209 | 195 | | business or other enti ty that, either directly or through an |
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210 | 196 | | intermediary, performs pharmacy benefit s management. The term |
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211 | 197 | | includes a person or entity acting for a PBM in a contract ual or |
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212 | 198 | | employment relationship in the performance of pharmacy benefits |
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213 | 199 | | management for a managed care company, nonprofit hospital, medi cal |
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214 | 200 | | service organization, insurance comp any, third-party payor, or a |
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215 | 201 | | health program administered by an agency of this stat e. PBM does |
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216 | 202 | | not include a Pharmacy Services Administrative Organization ; |
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217 | 203 | | 8. "Plan sponsor" means the employers, insurance companies, |
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218 | 204 | | unions and health maintenance organizations or any other entity |
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219 | 205 | | responsible for establishing, maintaining, or administering a health |
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220 | 206 | | benefit plan on behalf of covered individuals; and |
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221 | 207 | | 9. "Provider" means a pharmacy licensed by the State Board of |
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222 | 208 | | Pharmacy, or an agent or representative of a pharmacy, including, |
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223 | 209 | | but not limited to, the pharmacy's contracting agent, which |
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224 | 210 | | dispenses prescription drugs or devices to covered individuals. |
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225 | 211 | | SECTION 3. AMENDATORY 59 O.S. 2021, Section 358, is |
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226 | 212 | | amended to read as follows: |
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227 | 213 | | Section 358. A. In order to provide pharmacy benefits |
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228 | 214 | | management or any of the services included under the definition of |
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259 | 244 | | the Oklahoma Insurance D epartment, and the Department may charge a |
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260 | 245 | | fee for such licensure. |
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261 | 246 | | B. The Department shall establish, by regulation, licensure |
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262 | 247 | | procedures, required disclosures for pharmacy benefits managers |
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263 | 248 | | (PBMs) and other rules as may be necessary for carrying out and |
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264 | 249 | | enforcing the provisions of this act. The licensure procedures |
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265 | 250 | | shall, at a minimum, i nclude the completion of an application form |
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266 | 251 | | that shall include the name and address of an agent for service of |
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267 | 252 | | process, the payment of a requisite fee, and evidence of t he |
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268 | 253 | | procurement of a surety bond the following: |
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269 | 254 | | 1. The name, address, and telephone contact number of the PBM; |
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270 | 255 | | 2. The name and address of the PBM's agent for service of |
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271 | 256 | | process in the state; |
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272 | 257 | | 3. The name and address of each person with management or |
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273 | 258 | | control over the PBM; |
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274 | 259 | | 4. Evidence of the procurement of a surety bon d; |
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275 | 260 | | 5. The name and address of each person with a beneficial |
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276 | 261 | | ownership interest in the PBMs; |
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277 | 262 | | 6. In the case of a PBM applicant that is a partnership or |
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278 | 263 | | other unincorporated association, limited liability corporation, or |
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308 | 292 | | a. the applicant shall specify its legal structure and |
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309 | 293 | | the total number of partners, members, or |
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310 | 294 | | stockholders, |
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311 | 295 | | b. the applicant shall specify the name, address, usual |
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312 | 296 | | occupation, and professional qualifications of the |
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313 | 297 | | five partners, members , or stockholders with the five |
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314 | 298 | | largest ownership interests in the PBM, and |
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315 | 299 | | c. the applicant shall agree that, upon request by the |
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316 | 300 | | Department, it shall furnish the Department with |
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317 | 301 | | information regarding the name, address, usual |
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318 | 302 | | occupation, and professional qualifications of any |
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319 | 303 | | other partners, members, or stockholders; |
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320 | 304 | | 7. A signed statement indicating that the PBM has not been |
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321 | 305 | | convicted of a felony and has not violated any of the requirements |
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322 | 306 | | of the Oklahoma Pharmacy Act and the Patient 's Right to Pharmacy |
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323 | 307 | | Choice Act, or, if the applicant cannot provide such a statement, a |
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324 | 308 | | signed statement describing all relevant convictions or violations; |
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325 | 309 | | and |
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326 | 310 | | 8. Any other information the Com missioner deems necessary to |
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327 | 311 | | review. |
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328 | 312 | | C. The Department may subpoena witnesses and informa tion. Its |
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329 | 313 | | compliance officers may take and copy records for investigative use |
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358 | 341 | | of the Attorney General from using its investigative demand |
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359 | 342 | | authority to investigate and prosecute violation s of the law. |
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360 | 343 | | D. The Department may suspend , revoke or refuse to issue or |
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361 | 344 | | renew a license for noncompliance wi th any of the provisions hereby |
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362 | 345 | | established or with the rules promulgated by the Department; for |
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363 | 346 | | conduct likely to mislead, deceive or defraud th e public or the |
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364 | 347 | | Department; for unfair or de ceptive business practices or for |
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365 | 348 | | nonpayment of a renewal fee or fi ne. The Department may also levy |
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366 | 349 | | administrative fines for each count of which a PBM has been |
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367 | 350 | | convicted in a Department hearing. |
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368 | 351 | | SECTION 4. AMENDATORY 36 O.S. 2021 , Section 6960, as |
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369 | 352 | | amended by Section 1, Chapter 38, O.S.L. 2022 (3 6 O.S. Supp. 2022, |
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370 | 353 | | Section 6960), is amended to read as follows: |
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371 | 354 | | Section 6960. For purposes of the Patient 's Right to Pharmacy |
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372 | 355 | | Choice Act: |
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373 | 356 | | 1. "Administrative fees" means fees or payments from |
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374 | 357 | | pharmaceutical manufacturers to, or otherwise retained by, a |
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375 | 358 | | pharmacy benefits manager (PBM) or its designee pursuant to a |
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376 | 359 | | contract between a PBM or affiliate and the manufacturer in |
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377 | 360 | | connection with the PBM's administering, invoicing, alloc ating, and |
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378 | 361 | | collecting the rebates; |
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379 | 362 | | 2. "Aggregate retained rebate percentage" means the percentage |
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380 | 363 | | of all rebates received by a PBM from all pharmaceutical |
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409 | 391 | | health insurer clients. Aggregate retained rebate percentage shall |
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410 | 392 | | be expressed without disclosing any identifyi ng information |
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411 | 393 | | regarding any health plan, prescription drug, or therapeutic class, |
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412 | 394 | | and shall be calculated by dividi ng: |
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413 | 395 | | a. the aggregate dollar amount of all rebates that the |
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414 | 396 | | PBM received during the prior calendar year from al l |
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415 | 397 | | pharmaceutical manufacturers and did not pass through |
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416 | 398 | | to the PBM's health plan or health insurer clients, by |
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417 | 399 | | b. the aggregate dollar amount of all rebates that the |
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418 | 400 | | pharmacy benefits manager received duri ng the prior |
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419 | 401 | | calendar year from all pharmaceutical manufacturers; |
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420 | 402 | | 3. "Defined cost sharing" means a deductible payment or |
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421 | 403 | | coinsurance amount imposed on an enrollee for a cover ed prescription |
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422 | 404 | | drug under the enrollee's health plan; |
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423 | 405 | | 4. "Formulary" means a list of prescription drugs, as well as |
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424 | 406 | | accompanying tiering and other coverage inf ormation, that has been |
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425 | 407 | | developed by an issuer, a health plan, or the designee of a health |
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426 | 408 | | insurer or health plan, which the health insurer, health pla n, or |
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427 | 409 | | designee of the health insurer or health plan references in |
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428 | 410 | | determining applicable coverage and ben efit levels; |
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429 | 411 | | 5. "Generic equivalent" means a drug that is designated to be |
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430 | 412 | | therapeutically equivalent, as indicated by the United States Food |
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431 | 413 | | and Drug Administration's "Approved Drug Products with Therapeutic |
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460 | 441 | | be considered a generic equivalent until the drug becomes nationally |
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461 | 442 | | available; |
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462 | 443 | | 6. "Health insurer" means any corporation, associ ation, benefit |
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463 | 444 | | society, exchange, partnership or individual subject to state law |
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464 | 445 | | requires insurance and licensed by under the Oklahoma Insurance |
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465 | 446 | | Code; |
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466 | 447 | | 7. "Health insurer administrative service fees" means fees or |
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467 | 448 | | payments from a health insurer or a designee of the health insurer |
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468 | 449 | | to, or otherwise retained by, a PBM or its designee pursuant to a |
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469 | 450 | | contract between a PBM or affiliate, and the health insurer or |
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470 | 451 | | designee of the health insurer in connection with the PBM managing |
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471 | 452 | | or administering the pharmacy benefit and administering, invoicing, |
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472 | 453 | | allocating, and collecting rebates; |
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473 | 454 | | 2. 8. "Health insurer payor" means a health insurance company, |
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474 | 455 | | health maintenance organization, union, hospital and medical |
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475 | 456 | | services organization or any entity providing or admin istering a |
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476 | 457 | | self-funded health benefit plan; |
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477 | 458 | | 9. "Health plan" means a policy, contract, certification, or |
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478 | 459 | | agreement offered or issued by a health insurer to provide, deliver, |
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479 | 460 | | arrange for, pay for, or reimburse any of the costs of health |
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480 | 461 | | services; |
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511 | 491 | | 4. 11. "Pharmacy benefits manager" or "PBM" means a person |
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512 | 492 | | that, either directly or t hrough an intermediary, performs pharmacy |
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513 | 493 | | benefits management, as defined in paragra ph 6 of Section 357 of |
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514 | 494 | | Title 59 of the Oklahoma Statutes, and any other person acting for |
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515 | 495 | | such person under a contractual or employment relationship in the |
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516 | 496 | | performance of pharmacy benefits management for a managed -care |
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517 | 497 | | company, nonprofit hospital, medical service organization, insurance |
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518 | 498 | | company, third-party payor or a health program administered by a |
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519 | 499 | | department of this state. PBM does not include a Pharmacy Services |
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520 | 500 | | Administrative Organiz ation; |
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521 | 501 | | 12. "Pharmacy and therapeutics committee" or "P&T committee" |
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522 | 502 | | means a committee at a hospital or a health insurance plan that |
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523 | 503 | | decides which drugs will appear on that entity's drug formulary; |
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524 | 504 | | 13. "Price protection rebate" means a negotiated price |
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525 | 505 | | concession that accrues directly or indirectly to the health |
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526 | 506 | | insurer, or other party on behalf of the health insurer, in the |
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527 | 507 | | event of an increase in the wholesale acquisition of a drug above a |
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528 | 508 | | specified threshold; |
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529 | 509 | | 5. 14. "Provider" means a pharmacy, as defined in Section 353.1 |
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530 | 510 | | of Title 59 of the Oklahoma Statutes or an agent or representative |
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531 | 511 | | of a pharmacy; |
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562 | 541 | | as a rebate or otherwise) and reasonable estima tes of |
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563 | 542 | | any price protection rebates and performa nce-based |
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564 | 543 | | price concessions that may accrue d irectly or |
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565 | 544 | | indirectly to a health insurer, health plan, or PBM |
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566 | 545 | | during the coverage year from a manufacturer, |
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567 | 546 | | dispensing pharmacy, or other party in connection with |
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568 | 547 | | the dispensing or administration of a prescription |
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569 | 548 | | drug, and |
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570 | 549 | | b. reasonable estimates of any price concessions, fees , |
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571 | 550 | | and other administrative costs that are passed |
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572 | 551 | | through, or are reasonably anticipated to be passed |
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573 | 552 | | through, to a health insurer, health plan, or PBM and |
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574 | 553 | | serve to reduce the health insurer, health plan, or |
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575 | 554 | | PBM's liabilities for a pr escription drug; |
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576 | 555 | | 6. 16. "Retail pharmacy network" means retail pharmacy |
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577 | 556 | | providers contracted with a PBM in which the pharmacy primari ly |
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578 | 557 | | fills and sells prescriptions via a retail, storefront location; |
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579 | 558 | | 7. 17. "Rural service area" means a five-digit ZIP code in |
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580 | 559 | | which the population density is less than one thousand (1,000) |
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581 | 560 | | individuals per square mile; |
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612 | 590 | | differs from the amount the PBM directly or indirectly pays the |
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613 | 591 | | pharmacy or pharmacist for pr oviding pharmacy services; |
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614 | 592 | | 9. 19. "Suburban service area" means a five-digit ZIP code in |
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615 | 593 | | which the population density is between one thousand (1, 000) and |
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616 | 594 | | three thousand (3,000) individuals per square mile; and |
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617 | 595 | | 10. 20. "Urban service area" means a five-digit ZIP code in |
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618 | 596 | | which the population density is greater than three thous and (3,000) |
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619 | 597 | | individuals per square mile. |
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620 | 598 | | SECTION 5. AMENDATORY 36 O.S. 2021, Section 6962, as |
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621 | 599 | | amended by Section 2, Chapter 38, O.S.L. 2022 (36 O.S. Supp. 2022, |
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622 | 600 | | Section 6962), is am ended to read as follows: |
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623 | 601 | | Section 6962. A. The Oklahoma Insurance Department shall |
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624 | 602 | | review and approve retail pharmacy net work access for all pharmacy |
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625 | 603 | | benefits managers (PBMs) to ensure compliance with Section 6961 of |
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626 | 604 | | this title. |
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627 | 605 | | B. A PBM, or an agent of a PBM, shall not: |
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628 | 606 | | 1. Cause or knowingly pe rmit the use of advertisement, |
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629 | 607 | | promotion, solicitation, representation, proposa l or offer that is |
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630 | 608 | | untrue, deceptive or misleading; |
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631 | 609 | | 2. Charge a pharmacist or pharmacy a fee related to the |
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632 | 610 | | adjudication of a claim including without limitation a fee for: |
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663 | 640 | | c. the development or management of claims processing |
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664 | 641 | | services or claims payment services related to |
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665 | 642 | | participation in a retail pharmacy network; |
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666 | 643 | | 3. Reimburse a pharmacy or pharmacist in the state an amount |
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667 | 644 | | less than the amount that the PBM reim burses a pharmacy owned by or |
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668 | 645 | | under common ownership with a PBM for providing the same covered |
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669 | 646 | | services. The reimbursement amount paid to the pharmacy shall be |
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670 | 647 | | equal to the reimbursement amount calculated on a per -unit basis |
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671 | 648 | | using the same generic product identifier or generic code number |
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672 | 649 | | paid to the PBM-owned or PBM-affiliated pharmacy; |
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673 | 650 | | 4. Deny a provider the opportunity to participate in any |
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674 | 651 | | pharmacy network at preferred participation status if the provider |
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675 | 652 | | is willing to accept the terms and conditions that the PBM has |
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676 | 653 | | established for other providers as a condition of preferred network |
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677 | 654 | | participation status; |
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678 | 655 | | 5. Deny, limit or terminate a provider's contract based on |
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679 | 656 | | employment status of any employee who has an active license to |
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680 | 657 | | dispense, despite probatio n status, with the State Board of |
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681 | 658 | | Pharmacy; |
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713 | 689 | | b. to correct errors identified in an audit, so long as |
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714 | 690 | | the audit was conducted in compliance with Sections |
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715 | 691 | | 356.2 and 356.3 of Title 59 of the Oklahoma Statutes; |
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716 | 692 | | 7. Fail to make any payment due to a pharmacy or pharmacist for |
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717 | 693 | | covered services properly rendered in the event a PBM terminates a |
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718 | 694 | | provider from a pharmacy benefits manager network ; |
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719 | 695 | | 8. Conduct or practice Either directly or through an |
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720 | 696 | | intermediary, agent, or affiliate, engag e in, facilitate, or enter |
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721 | 697 | | into a contract with another person involv ing spread pricing, as |
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722 | 698 | | defined in Section 1 6960 of this act title, in this state; or |
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723 | 699 | | 9. Charge a pharmacist or pharmacy a fee related to |
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724 | 700 | | participation in a retail pharmacy network inclu ding but not limited |
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725 | 701 | | to the following: |
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726 | 702 | | a. an application fee, |
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727 | 703 | | b. an enrollment or participation fee, |
---|
728 | 704 | | c. a credentialing or re-credentialing fee, |
---|
729 | 705 | | d. a change of ownership fee , or |
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730 | 706 | | e. a fee for the development or manageme nt of claims |
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731 | 707 | | processing services or cl aims payment services ; or |
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732 | 708 | | 10. Prohibit or penalize a pharmacy or pha rmacist for: |
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764 | 739 | | (1) under his or her health plan prescription drug |
---|
765 | 740 | | benefit, or |
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766 | 741 | | (2) outside his or her health plan prescription drug |
---|
767 | 742 | | benefit, without requesting any health plan |
---|
768 | 743 | | reimbursement, than the drug that was orig inally |
---|
769 | 744 | | prescribed, or |
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770 | 745 | | b. selling to an individual, instead of a parti cular |
---|
771 | 746 | | prescribed drug, a therapeutically equivalent drug |
---|
772 | 747 | | that would be less expensive to the enrollee: |
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773 | 748 | | (1) under his or her health plan prescription drug |
---|
774 | 749 | | benefit, or |
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775 | 750 | | (2) outside his or her health plan prescription drug |
---|
776 | 751 | | benefit, without requesting any healt h plan |
---|
777 | 752 | | reimbursement, than the drug that was originally |
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778 | 753 | | prescribed. |
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779 | 754 | | C. The prohibitions under this section shall apply to contracts |
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780 | 755 | | between pharmacy benefits managers and providers for participation |
---|
781 | 756 | | in retail pharmacy networks. |
---|
782 | 757 | | 1. A PBM contract shall: |
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815 | 789 | | the drug and the amount an individual would pay to |
---|
816 | 790 | | purchase the drug directly, and |
---|
817 | 791 | | b. ensure that any entity that provides pharmacy benefits |
---|
818 | 792 | | management services under a contract with any such |
---|
819 | 793 | | health plan or health insurance coverage does not, |
---|
820 | 794 | | with respect to such plan or coverage, restrict, |
---|
821 | 795 | | directly or indirectly, a pharmacy that dispenses a |
---|
822 | 796 | | prescription drug from informing, or penalize such |
---|
823 | 797 | | pharmacy for informing, a covered individual of any |
---|
824 | 798 | | differential between the individual's out-of-pocket |
---|
825 | 799 | | cost under the plan or coverage with respect to |
---|
826 | 800 | | acquisition of the drug and the amount an individual |
---|
827 | 801 | | would pay for acquisition of the drug without using |
---|
828 | 802 | | any health plan or health insurance coverage. |
---|
829 | 803 | | 2. A pharmacy benefit s manager's contract with a provider shall |
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830 | 804 | | not prohibit, restrict or limit disclosure of information to the |
---|
831 | 805 | | Insurance Commissioner, law enforcement or state and federal |
---|
832 | 806 | | governmental officials investigating or examining a complaint or |
---|
865 | 838 | | Programs' current standards to communica te information to pharmacies |
---|
866 | 839 | | submitting claim inquiries; |
---|
867 | 840 | | 2. Fully disclose to insurers, self-funded employers, unions or |
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868 | 841 | | other PBM clients the existence of the respective aggregate |
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869 | 842 | | prescription drug discounts, rebates received from dr ug |
---|
870 | 843 | | manufacturers and pharmacy audit recoupments; |
---|
871 | 844 | | 3. Provide the Insu rance Commissioner, insurers, self-funded |
---|
872 | 845 | | employer plans and unions unrestricted audit rights of and access to |
---|
873 | 846 | | the respective PBM pharmaceutical manu facturer and provider |
---|
874 | 847 | | contracts, plan utilization data, plan pricing data, pharmacy |
---|
875 | 848 | | utilization data and ph armacy pricing data; |
---|
876 | 849 | | 4. Maintain, for no less than three (3) years, documentation of |
---|
877 | 850 | | all network development activities including but not limited to |
---|
878 | 851 | | contract negotiations and any denials to providers to join networks. |
---|
879 | 852 | | This documentation shall be made ava ilable to the Commissioner upon |
---|
880 | 853 | | request; |
---|
881 | 854 | | 5. Report to the Commissioner, on a quarterly basis in a manner |
---|
882 | 855 | | and form prescribed by the Commissioner , along with any applicable |
---|
883 | 856 | | fees set by the Commissioner, a report on the first day of each |
---|
916 | 888 | | a. the aggregate amount of rebates received by the PBM |
---|
917 | 889 | | received from all pharmaceutical manufacturers , |
---|
918 | 890 | | b. the aggregate amount of rebates distributed to the |
---|
919 | 891 | | appropriate health insurer payor, |
---|
920 | 892 | | c. the aggregate amount of rebates that the PBM received |
---|
921 | 893 | | from all pharmaceutical manufacturers and did not pass |
---|
922 | 894 | | through to health insurers, |
---|
923 | 895 | | d. the aggregate amount of rebates passed on to the |
---|
924 | 896 | | enrollees of each health insur er payor at the point of |
---|
925 | 897 | | sale that reduced the applicable deductible, |
---|
926 | 898 | | copayment, coinsure or other defined cost sharing |
---|
927 | 899 | | amount of the enrollee, |
---|
928 | 900 | | d. |
---|
929 | 901 | | e. the aggregate amount of all administrative fees the |
---|
930 | 902 | | PBM received, |
---|
931 | 903 | | f. the aggregate amount of health insurer administrative |
---|
932 | 904 | | service fees that the PBM received, |
---|
| 905 | + | g. the aggregate amount of all administrative fees tha t |
---|
| 906 | + | the PBM received from all pharmaceutical manufacturers |
---|
| 907 | + | and did not pass through to health insurers, |
---|
| 908 | + | h. the aggregate retained rebate perc entage, across all |
---|
| 909 | + | the PBM's contractual or othe r relationships with all |
---|
| 910 | + | health insurers, the highest aggregate re tained rebate |
---|
| 911 | + | percentage, the lowest aggregate retained rebate |
---|
960 | | - | g. the aggregate amount of all administrative fees tha t |
---|
961 | | - | the PBM received from all pharmaceutical manufacturers |
---|
962 | | - | and did not pass through to health insurers, |
---|
963 | | - | h. the aggregate retained rebate perc entage, across all |
---|
964 | | - | the PBM's contractual or othe r relationships with all |
---|
965 | | - | health insurers, the highest aggregate re tained rebate |
---|
966 | | - | percentage, the lowest aggregate retained rebate |
---|
967 | 938 | | percentage, and the mean aggregate retained rebate |
---|
968 | 939 | | percentage, |
---|
969 | 940 | | i. the individual and aggregate amount paid by the health |
---|
970 | 941 | | insurer payor to the PBM for pharmacy services |
---|
971 | 942 | | itemized by pharmacy, dru g product and service |
---|
972 | 943 | | provided, and |
---|
973 | 944 | | e. |
---|
974 | 945 | | j. the individual and aggregate amount a PBM paid a |
---|
975 | 946 | | provider for pharmacy services itemize d by pharmacy, |
---|
976 | 947 | | drug product and service provided. |
---|
977 | 948 | | The Department shall publish in a timely manner the information |
---|
978 | 949 | | that it receives under paragraph 5 of this subsection on a publicly |
---|
979 | 950 | | available website; provided that such information shall be made |
---|
980 | 951 | | available in a form that does not disclose the identity of a |
---|
981 | 952 | | specific health plan or the identity of a specific manufacturer, the |
---|
982 | 953 | | prices charged for specific drugs or classes of drugs, or the amount |
---|
983 | 954 | | of any rebates provided for specific drugs or classes of drugs. |
---|
| 955 | + | E. For each of the PBM's contracts or other relationships with |
---|
| 956 | + | a health plan, a PBM shall publish on an easily a ccessible website |
---|
| 957 | + | the health plan formulary, and timely notification of formulary |
---|
| 958 | + | changes and/or product exclusions. |
---|
| 959 | + | F. The PBM and the Department shall not publish or otherwise |
---|
| 960 | + | disclose any information tha t would reveal the identity of a |
---|
| 961 | + | specific health plan, the price(s ) charged for a specific drug or |
---|
1011 | | - | E. For each of the PBM's contracts or other relationships with |
---|
1012 | | - | a health plan, a PBM shall publish on an easily a ccessible website |
---|
1013 | | - | the health plan formulary, and timely notification of formulary |
---|
1014 | | - | changes and/or product exclusions. |
---|
1015 | | - | F. The PBM and the Department shall not publish or otherwise |
---|
1016 | | - | disclose any information tha t would reveal the identity of a |
---|
1017 | | - | specific health plan, the price(s ) charged for a specific drug or |
---|
1018 | 988 | | class of drugs, the amount of any rebates provided for a specific |
---|
1019 | 989 | | drug or class of drugs, the manufacturer, or that wou ld otherwise |
---|
1020 | 990 | | have the potential to com promise the financial, competitive, or |
---|
1021 | 991 | | proprietary nature of the information. Any such information shall |
---|
1022 | 992 | | be protected from disclosure as confidential and proprietary |
---|
1023 | 993 | | information, is not a public record as defined in t he Oklahoma Open |
---|
1024 | 994 | | Records Act, Section 24A.1 et seq. of Title 51 of the Oklahoma |
---|
1025 | 995 | | Statutes, and shall not be disclosed directly or indirectly. A PBM |
---|
1026 | 996 | | shall impose the confidentiality protections of this section o n any |
---|
1027 | 997 | | vendor or downstream third party that pe rforms health care or |
---|
1028 | 998 | | administrative services on behalf of the PBM and that may receive or |
---|
1029 | 999 | | have access to rebate information. |
---|
1030 | 1000 | | SECTION 6. AMENDATORY 36 O.S. 2021, Section 6964, is |
---|
1031 | 1001 | | amended to read as follows: |
---|
1032 | 1002 | | Section 6964. A. A health insurer's insurer or its agent's, |
---|
1033 | 1003 | | including pharmacy benefits managers, pharmacy and therapeutics |
---|
1034 | 1004 | | committee (P&T committee) shall establish a formulary, which shall |
---|
1074 | 1043 | | 2. A health insurer shall requi re any member of the P&T |
---|
1075 | 1044 | | committee to disclose any compensation or funding from a |
---|
1076 | 1045 | | pharmaceutical manufacturer, deve loper, labeler, wholesaler or |
---|
1077 | 1046 | | distributor. Such P&T committee member shall be recused from voting |
---|
1078 | 1047 | | on any product manufactured or sold by suc h pharmaceutical |
---|
1079 | 1048 | | manufacturer, developer, labeler, wholesaler or distributor. P&T |
---|
1080 | 1049 | | committee members shall practice in various clinical specialties |
---|
1081 | 1050 | | that adequately represent the needs of health plan enrollees, and |
---|
1082 | 1051 | | there shall be an adequate number of high -volume specialists and |
---|
1083 | 1052 | | specialists treating rare and orphan diseases; |
---|
1084 | 1053 | | 3. The P&T committee shall meet no less frequently than on a |
---|
1085 | 1054 | | quarterly basis; |
---|
1119 | 1087 | | Medicaid managed care organizations' prescription drug coverage |
---|
1120 | 1088 | | policies, if the P&T committee relies upon any thi rd party to |
---|
1121 | 1089 | | provide cost-effectiveness analysis or research, the P&T committee |
---|
1122 | 1090 | | shall: |
---|
1123 | 1091 | | a. disclose to the health benefit plan, the state, and |
---|
1124 | 1092 | | the general public the name of the relevant third |
---|
1125 | 1093 | | party, and |
---|
1126 | 1094 | | b. provide a process through which patients and provi ders |
---|
1127 | 1095 | | potentially impacted by the third party's analysis or |
---|
1128 | 1096 | | research may provide input to the P&T committee; |
---|
1129 | 1097 | | 5. Specialists with current clinical expertise who actively |
---|
1130 | 1098 | | treat patients in a specific therapeutic area, and the specific |
---|
1131 | 1099 | | conditions within a the rapeutic area, shall participate in formulary |
---|
1132 | 1100 | | decisions regarding each therapeutic area an d specific condition; |
---|
1133 | 1101 | | 6. The P&T committee shall base its clinical decisions on the |
---|
1134 | 1102 | | strength of scientific evidence, standards of practice, and |
---|
1135 | 1103 | | nationally accepted tre atment guidelines; |
---|
1170 | 1137 | | 9. The P&T committee shall review formulary management |
---|
1171 | 1138 | | activities, including exceptions and appeals processes, prior |
---|
1172 | 1139 | | authorization, step therapy, quantity limits, generic substitutions, |
---|
1173 | 1140 | | therapeutic interchange, a nd other drug utilizati on management |
---|
1174 | 1141 | | activities for clinical appropriateness and consistency with |
---|
1175 | 1142 | | industry standards and patient and provider organization guidelines; |
---|
1176 | 1143 | | 10. The P&T committee shall annually review and provide a |
---|
1177 | 1144 | | written report to the pharmacy benefits manager on: |
---|
1178 | 1145 | | a. the percentage of prescription drugs on formulary |
---|
1179 | 1146 | | subject to each of the types of utilization management |
---|
1180 | 1147 | | described in paragraph 9 of this subsection, |
---|
1181 | 1148 | | b. rates of adherence and nonadherence to medicines by |
---|
1182 | 1149 | | therapeutic area, |
---|
1183 | 1150 | | c. rates of abandonment of medicines by therapeutic area, |
---|
1184 | 1151 | | d. recommendations for improved adherence and reduced |
---|
1185 | 1152 | | abandonment, |
---|
1220 | 1186 | | within ninety (90) days of such drug's approval, or shall provide a |
---|
1221 | 1187 | | clinical justification if this time frame is not met; |
---|
1222 | 1188 | | 12. The P&T committee shall review procedures for medical |
---|
1223 | 1189 | | review of, and transiti oning new plan enrollees to, appropria te |
---|
1224 | 1190 | | formulary alternatives to en sure that such procedures a ppropriately |
---|
1225 | 1191 | | address situations involving enrollees stabilized on drugs that are |
---|
1226 | 1192 | | not on the health plan formulary (or that are on formulary but |
---|
1227 | 1193 | | subject to prior authorization, step therapy, or other utilization |
---|
1228 | 1194 | | management requirements). |
---|
1229 | 1195 | | C. The health insurer, its agents, including pharmacy benefits |
---|
1230 | 1196 | | managers, and the Department shall not publish or otherwise disclose |
---|
1231 | 1197 | | any confidential, propriet ary information, inc luding, but not |
---|
1232 | 1198 | | limited to, any information that would reveal the identi ty of a |
---|
1233 | 1199 | | specific health plan, the prices charged for a specific drug or |
---|
1234 | 1200 | | class of drugs, the amount of any rebates provided for a specific |
---|
1235 | 1201 | | drug or class of drugs, th e manufacturer, or t hat would otherwise |
---|
1236 | 1202 | | have the potential to compromise the financial, co mpetitive, or |
---|
| 1203 | + | proprietary nature of the information. Any such information shall |
---|
| 1204 | + | be protected from disclosure as confidential and proprietary |
---|
| 1205 | + | information, is not a pu blic record as defin ed in the Oklahoma Open |
---|
| 1206 | + | Records Act, Section 24A.1 et seq. of Title 51 of the Oklaho ma |
---|
| 1207 | + | Statutes, and shall not be disclosed directly or indirectly. A |
---|
| 1208 | + | health insurer shall impose the confidentiality protections of this |
---|
| 1209 | + | section on any vendor or downstream t hird party that performs health |
---|
1264 | | - | proprietary nature of the information. Any such information shall |
---|
1265 | | - | be protected from disclosure as confidential and proprietary |
---|
1266 | | - | information, is not a pu blic record as defin ed in the Oklahoma Open |
---|
1267 | | - | Records Act, Section 24A.1 et seq. of Title 51 of the Oklaho ma |
---|
1268 | | - | Statutes, and shall not be disclosed directly or indirectly. A |
---|
1269 | | - | health insurer shall impose the confidentiality protections of this |
---|
1270 | | - | section on any vendor or downstream t hird party that performs health |
---|
1271 | 1236 | | care or administrative services on behalf of the pharmac y benefits |
---|
1272 | 1237 | | manager that may receive or have access to rebate information. |
---|
1273 | 1238 | | SECTION 7. NEW LAW A new section of law to be codified |
---|
1274 | 1239 | | in the Oklahoma Statutes as Section 6962.2 of Title 36, unless there |
---|
1275 | 1240 | | is created a duplication in numbering, reads as fo llows: |
---|
1276 | 1241 | | A. An enrollee's defined cost sharing for each prescription |
---|
1277 | 1242 | | drug shall be calculated at the point of s ale based on a price that |
---|
1278 | 1243 | | is reduced by an amount equal to at least eighty-five percent (85%) |
---|
1279 | 1244 | | of all rebates received, or to be received, in connection with the |
---|
1280 | 1245 | | dispensing or administration of the prescription drug. |
---|
1281 | 1246 | | B. For any violation of this section, the Insurance |
---|
1282 | 1247 | | Commissioner may subject a PB M to an administrative penalty of not |
---|
1283 | 1248 | | less than One Hundred Dollars ( $100.00) nor more than Ten Thousand |
---|
1284 | 1249 | | Dollars ($10,000.00) for each occurrence. Such administrative |
---|
1285 | 1250 | | penalty may be enforced in the same manner in w hich civil judgments |
---|
1286 | 1251 | | may be enforced. |
---|
1321 | 1285 | | E. In complying with the provisions of this section, a PBM or |
---|
1322 | 1286 | | its agents shall not publish or otherwise reveal information |
---|
1323 | 1287 | | regarding the actual amount of reb ates a PBM receives on a product |
---|
1324 | 1288 | | or therapeutic class of p roducts, manufacturer, or pharmacy -specific |
---|
1325 | 1289 | | basis. Such information is protected as a trade secret, is not a |
---|
1326 | 1290 | | public record as defined in the Oklahoma Open Records Act, Section |
---|
1327 | 1291 | | 24A.1 et seq. of Title 51 of the Oklahoma Statutes, and shall not be |
---|
1328 | 1292 | | disclosed directly or indirectly, or in a manner that would allow |
---|
1329 | 1293 | | for the identification of an individual product, therapeutic class |
---|
1330 | 1294 | | of products, or manufacturer, or in a manner that would have the |
---|
1331 | 1295 | | potential to compromise the fi nancial, competitive, or proprietary |
---|
1332 | 1296 | | nature of the information. A PBM shall impose the confidentiality |
---|
1333 | 1297 | | protections of this section on any vendor or downstream third party |
---|
1334 | 1298 | | that performs health care or administrative services on behalf o f |
---|
1335 | 1299 | | the insurer that may receive or have access to rebate information. |
---|
| 1300 | + | SECTION 8. NEW LAW A new sectio n of law to be codified |
---|
| 1301 | + | in the Oklahoma Statutes as Section 6970 of Title 36, unless there |
---|
| 1302 | + | is created a duplication in numbering, reads as follows: |
---|
| 1303 | + | A. For purposes of this section: |
---|
| 1304 | + | 1. "Defined cost sharing" means a deductible payment or |
---|
| 1305 | + | coinsurance amount imposed on an enrollee for a covered prescription |
---|
| 1306 | + | drug under the enrollee's health plan; |
---|
| 1307 | + | 2. "Insurer" means any health insurance issuer that is subje ct |
---|
| 1308 | + | to state law regulating in surance and offers health insuranc e |
---|
1363 | | - | SECTION 8. NEW LAW A new sectio n of law to be codified |
---|
1364 | | - | in the Oklahoma Statutes as Section 6970 of Title 36, unless there |
---|
1365 | | - | is created a duplication in numbering, reads as follows: |
---|
1366 | | - | A. For purposes of this section: |
---|
1367 | | - | 1. "Defined cost sharing" means a deductible payment or |
---|
1368 | | - | coinsurance amount imposed on an enrollee for a covered prescription |
---|
1369 | | - | drug under the enrollee's health plan; |
---|
1370 | | - | 2. "Insurer" means any health insurance issuer that is subje ct |
---|
1371 | | - | to state law regulating in surance and offers health insurance |
---|
1372 | 1335 | | coverage, as defined in 42 U.S.C. , Section 300gg-91, or any state or |
---|
1373 | 1336 | | local governmental employer plan; |
---|
1374 | 1337 | | 3. "Price protection rebate" means a negotiated price |
---|
1375 | 1338 | | concession that accrues directly or indirectly to the insurer, or |
---|
1376 | 1339 | | other party on behalf of the i nsurer, in the event of an increase in |
---|
1377 | 1340 | | the wholesale acquisition cost of a drug above a specified |
---|
1378 | 1341 | | threshold; |
---|
1379 | 1342 | | 4. "Rebate" means: |
---|
1380 | 1343 | | a. negotiated price concessions including , but not |
---|
1381 | 1344 | | limited to, base price concessions (whethe r described |
---|
1382 | 1345 | | as a rebate or otherwise) and reasonable estimates of |
---|
1383 | 1346 | | any price protection rebates and performance-based |
---|
1384 | 1347 | | price concessions that may accrue directly or |
---|
1385 | 1348 | | indirectly to the insurer during the coverag e year |
---|
1386 | 1349 | | from a manufacturer, dispensing pharmacy, or other |
---|
| 1350 | + | party in connection with the dispensing or |
---|
| 1351 | + | administration of a pre scription drug, and |
---|
| 1352 | + | b. reasonable estimates of any negotiated price |
---|
| 1353 | + | concessions, fees, and other administrative costs that |
---|
| 1354 | + | are passed through, or are re asonably anticipated to |
---|
| 1355 | + | be passed through, to the insurer and s erve to reduce |
---|
| 1356 | + | the insurer's liabilities for a prescription drug. |
---|
| 1357 | + | B. An enrollee's defined cost sharing for each prescription |
---|
| 1358 | + | drug shall be calculated at the point of sale based on a price tha t |
---|
1414 | | - | party in connection with the dispensing or |
---|
1415 | | - | administration of a pre scription drug, and |
---|
1416 | | - | b. reasonable estimates of any negotiated price |
---|
1417 | | - | concessions, fees, and other administrative costs that |
---|
1418 | | - | are passed through, or are re asonably anticipated to |
---|
1419 | | - | be passed through, to the insurer and serve to reduce |
---|
1420 | | - | the insurer's liabilities for a prescription drug. |
---|
1421 | | - | B. An enrollee's defined cost sharing for each prescription |
---|
1422 | | - | drug shall be calculated at the point of sale based on a price tha t |
---|
1423 | 1385 | | is reduced by an amount equ al to at least eighty-five percent (85%) |
---|
1424 | 1386 | | of all rebates received, or to be received, in connection with the |
---|
1425 | 1387 | | dispensing or administration of the prescription drug. |
---|
1426 | 1388 | | C. For any violation of this section, the I nsurance |
---|
1427 | 1389 | | Commissioner may subject an insurer to an administrative penalty of |
---|
1428 | 1390 | | not less than One Hundred Dollars ($100.00) nor more than Ten |
---|
1429 | 1391 | | Thousand Dollars ($10,000.00) for each occurrence. Such |
---|
1430 | 1392 | | administrative penalty may be enforced in the same manner in which |
---|
1431 | 1393 | | civil judgments may be enforced. |
---|
1432 | 1394 | | D. Nothing in subsections A through C of this section shall |
---|
1433 | 1395 | | preclude an insurer fro m decreasing an enrollee's defined cost |
---|
1434 | 1396 | | sharing by an amount greater than that required under subsection B |
---|
1435 | 1397 | | of this section. |
---|
| 1398 | + | E. In implementing the requ irements of this section, the state |
---|
| 1399 | + | shall only regulate an insurer to the extent permissible under |
---|
| 1400 | + | applicable law. |
---|
| 1401 | + | F. In complying with the provisions of this section, an insurer |
---|
| 1402 | + | or its agents shall not publish or otherwise reveal info rmation |
---|
| 1403 | + | regarding the actual amount of rebates an insurer receives on a |
---|
| 1404 | + | product or therapeutic class of pr oducts, manufacturer, or pharmacy- |
---|
| 1405 | + | specific basis. Such information is protected as a trade secret, is |
---|
| 1406 | + | not a public record as defined in the Oklahoma Open Records Act, |
---|
| 1407 | + | Section 24A.1 et seq. of Title 51 of the Oklahoma Statutes, and |
---|
| 1408 | + | shall not be disclosed directly or indirectly, or in a manner that |
---|
1463 | | - | E. In implementing the requ irements of this section, the state |
---|
1464 | | - | shall only regulate an insurer to the extent permissible under |
---|
1465 | | - | applicable law. |
---|
1466 | | - | F. In complying with the provisions of this section, an insurer |
---|
1467 | | - | or its agents shall not publish or otherwise reveal info rmation |
---|
1468 | | - | regarding the actual amount of rebates an insurer receives on a |
---|
1469 | | - | product or therapeutic class of pr oducts, manufacturer, or pharmacy- |
---|
1470 | | - | specific basis. Such information is protected as a trade secret, is |
---|
1471 | | - | not a public record as defined in the Oklahoma Open Records Act, |
---|
1472 | | - | Section 24A.1 et seq. of Title 51 of the Oklahoma Statutes, and |
---|
1473 | | - | shall not be disclosed directly or indirectly, or in a manner that |
---|
1474 | 1435 | | would allow for the identification of an individual product, |
---|
1475 | 1436 | | therapeutic class of product s, or manufacturer, or in a manner tha t |
---|
1476 | 1437 | | would have the potential to compromise the financial, competitive, |
---|
1477 | 1438 | | or proprietary nature of the information. An insurer shall impose |
---|
1478 | 1439 | | the confidentiality protections of this section on any vendor or |
---|
1479 | 1440 | | downstream third party that performs health care or adm inistrative |
---|
1480 | 1441 | | services on behalf of the insurer and that may receive or have |
---|
1481 | 1442 | | access to rebate information. |
---|
1482 | 1443 | | SECTION 9. This act shall become effective November 1, 2023. |
---|