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53 | 53 | | STATE OF OKLAHOMA |
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54 | 54 | | |
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55 | 55 | | 1st Session of the 60th Legislature (2025) |
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56 | 56 | | |
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57 | 57 | | SENATE BILL 1030 By: Howard |
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58 | 58 | | |
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59 | 59 | | |
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60 | 60 | | |
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61 | 61 | | |
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62 | 62 | | |
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63 | 63 | | AS INTRODUCED |
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64 | 64 | | |
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65 | 65 | | An Act relating to prescription drug pricing; |
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66 | 66 | | creating the 340B Drug Pricing Nondiscrimination Act; |
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67 | 67 | | providing short title; defining terms; prohibiting |
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68 | 68 | | certain reimbursement rates; prohibiting certain |
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69 | 69 | | terms or conditions on a 340B entity; prohibiting |
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70 | 70 | | certain interference on certain patient choice; |
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71 | 71 | | prohibiting certain provisions in certain contracts; |
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72 | 72 | | requiring submission of certain cost data; providing |
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73 | 73 | | certain exceptions; prohibiting manufacturers or |
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74 | 74 | | distributors from limiting certain drug actions; |
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75 | 75 | | prohibiting certain contracts; providing for |
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76 | 76 | | promulgation of rules; establishing certain fines or |
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77 | 77 | | fees; providing certain exceptions; amending 36 O.S. |
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78 | 78 | | 2021, Sections 6960 and 6962, as last amended by |
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79 | 79 | | Sections 1 and 2, Chapter 306, O.S.L. 2024 (36 O.S. |
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80 | 80 | | Supp. 2024, Sections 6960 and 6962), which relate to |
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81 | 81 | | definitions and compliance review; defining terms; |
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82 | 82 | | prohibiting certain provider requirements; |
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83 | 83 | | prohibiting certain billing modifier; prohibiting |
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84 | 84 | | certain modifications; prohibiting certain provider |
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85 | 85 | | exclusions; prohibiting participation in certain |
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86 | 86 | | networks; prohibiting bas ing certain decisions on |
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87 | 87 | | certain drug pricing; eliminating certain |
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88 | 88 | | contracting; amending Section 3, Chapter 38, O.S.L. |
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89 | 89 | | 2022, as last amended by Section 4, Chapter 306, |
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90 | 90 | | O.S.L. 2024 (36 O.S. Supp. 2024, Section 6966.1) , |
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91 | 91 | | which relates to violations; establishing certain |
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92 | 92 | | finality of certain claims; providing for |
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93 | 93 | | codification; and providi ng an effective date. |
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94 | 94 | | |
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95 | 95 | | |
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96 | 96 | | |
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97 | 97 | | BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA: |
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98 | 98 | | |
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99 | 99 | | |
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148 | 148 | | |
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149 | 149 | | SECTION 1. NEW LAW A new section of law to be codified |
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150 | 150 | | in the Oklahoma Statutes as Section 5400 of Title 36, unless there |
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151 | 151 | | is created a duplication in numbering, reads as follows: |
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152 | 152 | | This act shall be known and may be cited as the “340B Drug |
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153 | 153 | | Pricing Nondiscrimination Act ”. |
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154 | 154 | | SECTION 2. NEW LAW A new sec tion of law to be codified |
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155 | 155 | | in the Oklahoma Statutes as Section 5401 of Title 36 , unless there |
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156 | 156 | | is created a duplication in numbering, reads as follows: |
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157 | 157 | | As used in this act: |
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158 | 158 | | 1. “340B drug” means a drug that has been subject to any |
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159 | 159 | | reduced purchase price by a manufacturer pursuant to Section 256b of |
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160 | 160 | | Title 42 of the United States Code and is purchased by a covered |
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161 | 161 | | entity as defined in Section 256b(a)(4) of Title 42 of the United |
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162 | 162 | | States Code; |
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163 | 163 | | 2. “340B entity” means an entity participating or authorized to |
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164 | 164 | | participate in the federal 340B drug pricing program, as described |
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165 | 165 | | in Section 256b of Title 42 of the United States Code, including its |
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166 | 166 | | pharmacy, or any pharmacy contracted with the participating entity |
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167 | 167 | | to dispense drugs purchased through the 340B drug pricing program; |
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168 | 168 | | 3. “Distributor” means a person other than a manufacturer, a |
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169 | 169 | | manufacturer’s co-licensed partner, a third -party logistics |
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170 | 170 | | provider, or repackager engaged in wholesale distribution as defined |
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171 | 171 | | by Section 353(e)(4) of Title 21 of the United States C ode as |
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172 | 172 | | amended by the Drug Supply Chain Security Act; |
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173 | 173 | | |
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174 | 174 | | |
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224 | 224 | | 4. “Manufacturer” means: |
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225 | 225 | | a. a person that holds an application approved under |
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226 | 226 | | Section 355 of Title 21 of the United States Code or a |
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227 | 227 | | license issued under Section 262 of Title 42 of the |
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228 | 228 | | United States Code for such product, or if such |
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229 | 229 | | product is not the subject of an approved application |
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230 | 230 | | or license, the person who manufactured the product, |
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231 | 231 | | b. a co-licensed partner of the person described in |
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232 | 232 | | subparagraph a of this paragraph that obtains the |
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233 | 233 | | product directly from a person described in this |
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234 | 234 | | subparagraph or subparagraph a of this paragr aph, |
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235 | 235 | | c. an affiliate of a person described in subparagraph a |
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236 | 236 | | or b of this paragraph who receives the product |
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237 | 237 | | directly from a person described in this subparagraph |
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238 | 238 | | or in subparagraph a or b of this paragraph, or |
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239 | 239 | | d. a person who contracts with another to manufacture a |
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240 | 240 | | product; |
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241 | 241 | | 5. “Pharmacy” means a pharmacy licensed by the State Board of |
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242 | 242 | | Pharmacy, provided patients who receive pharmacy care shall be |
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243 | 243 | | physically located in the state ; and |
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244 | 244 | | 6. “Pharmacy benefits manager ” means a person that performs |
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245 | 245 | | pharmacy benefits management and any other person acting for such |
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246 | 246 | | person under a contractual or employment relationship in the |
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247 | 247 | | performance of pharmacy benefits management for a managed care |
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248 | 248 | | |
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249 | 249 | | |
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298 | 298 | | |
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299 | 299 | | company, nonprofit hospital, medical service organization, insurance |
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300 | 300 | | company, third-party payor, or a health program administered by a |
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301 | 301 | | department of this state. |
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302 | 302 | | SECTION 3. NEW LAW A new section of law to be codified |
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303 | 303 | | in the Oklahoma Statutes as Section 5402 of Title 36, unless there |
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304 | 304 | | is created a duplication in numbering, reads as follows: |
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305 | 305 | | A. With respect to reimbursement to a 340B entity for 340B |
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306 | 306 | | drugs, a health insurance issuer, pharmacy benefits manager, other |
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307 | 307 | | third-party payor, or its agent shall not: |
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308 | 308 | | 1. Reimburse a 340B entity for 340B drugs at a rate lower than |
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309 | 309 | | that paid for the same drug to entities that are not 340B entities |
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310 | 310 | | or lower reimbursement for a claim on the basis that the claim is |
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311 | 311 | | for a 340B drug; |
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312 | 312 | | 2. Impose any terms or conditions on any 340B entity with |
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313 | 313 | | respect to any of the following that di ffer from such terms or |
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314 | 314 | | conditions applied to non -340B entities on the basis that the entity |
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315 | 315 | | participates in the federal 340B drug pricing program set forth in |
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316 | 316 | | Section 256b of Title 42 of the United States Code or that a drug is |
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317 | 317 | | a 340B drug. Such terms and conditions shall include, but not be |
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318 | 318 | | limited to, any of the following: |
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319 | 319 | | a. fees, charges, clawbacks, or other adjustments or |
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320 | 320 | | assessments. For purposes of this subparagraph, th e |
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321 | 321 | | term “other adjustments” includes placing any |
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322 | 322 | | additional requirements, restri ctions, or unnecessary |
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323 | 323 | | |
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324 | 324 | | |
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373 | 373 | | |
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374 | 374 | | burdens upon the 340B entity that result in |
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375 | 375 | | administrative costs or fees to the 340B entity that |
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376 | 376 | | are not placed upon other entities that do not |
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377 | 377 | | participate in the 340B drug pricing program, |
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378 | 378 | | including affiliate pharmacies of the health insurance |
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379 | 379 | | issuer, pharmacy benefits manager, or other third - |
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380 | 380 | | party payor, |
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381 | 381 | | b. dispensing fees that are less than the dispensing fees |
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382 | 382 | | for non-340B entities, |
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383 | 383 | | c. restrictions or requirements regarding participation |
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384 | 384 | | in standard or preferred pharmacy networks, |
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385 | 385 | | d. requirements relating to the frequency or scope of |
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386 | 386 | | audits of inventory management systems, |
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387 | 387 | | e. requirements that a claim for a drug include any |
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388 | 388 | | identification, billing modifie r, attestation, or |
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389 | 389 | | other indication that a drug is a 340B drug in order |
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390 | 390 | | to be processed or resubmitted unless it is required |
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391 | 391 | | by the Centers for Medicare and Medicaid Services or |
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392 | 392 | | the Oklahoma Health Care Authority for the |
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393 | 393 | | administration of the Oklahoma Medi caid program, or |
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394 | 394 | | f. any other restrictions, conditions, practice s, or |
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395 | 395 | | policies that are not imposed on non -340B entities; |
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396 | 396 | | 3. Require a 340B entity to reverse, resubmit, or clarify a |
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397 | 397 | | claim after the initial adjudication unless these actions are in the |
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448 | 448 | | |
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449 | 449 | | normal course of pharmacy business and not related to 340B drug |
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450 | 450 | | pricing; |
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451 | 451 | | 4. Discriminate against a 340B entity in a manner that prevents |
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452 | 452 | | or interferes with any patient ’s choice to receive such drugs from |
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453 | 453 | | the 340B entity, including the administration of such d rugs. For |
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454 | 454 | | purposes of this subsection, it is considered a discriminatory |
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455 | 455 | | practice that prevents or interferes with a patient ’s choice to |
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456 | 456 | | receive drugs at a 340B entity if a health insurance issuer, |
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457 | 457 | | pharmacy benefits manager, or other third -party payor places any |
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458 | 458 | | additional requirements, restrictions, or unnecessary burdens upon |
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459 | 459 | | the 340B entity including, but not limited to, requiring a claim for |
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460 | 460 | | a drug to include any identification, billing modifier, attestation, |
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461 | 461 | | or other indication that a drug is a 340B d rug in order to be |
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462 | 462 | | processed or resubmitted unless it is required by the Center s for |
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463 | 463 | | Medicare and Medicaid Services or the Oklahoma Health Care Authority |
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464 | 464 | | in administration of the Oklahoma Medicaid program; |
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465 | 465 | | 5. Include any other provision in a contract betw een a health |
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466 | 466 | | insurance issuer, pharmacy benefits manager, or other third -party |
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467 | 467 | | payor and a 340B entity that discriminates against the 340B entity |
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468 | 468 | | or prevents or interferes with an individual ’s choice to receive a |
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469 | 469 | | prescription drug from 340B entity, includi ng the administration of |
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470 | 470 | | the drug, in person or via direct delivery, mail, or o ther form of |
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471 | 471 | | shipment, or creation of a restriction or additional charge on a |
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472 | 472 | | patient who chooses to receive drugs from a 340B entity; |
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473 | 473 | | |
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524 | 524 | | 6. Require or compel the submission of in gredient costs or |
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525 | 525 | | pricing data pertaining to 340B drugs to any health insurance |
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526 | 526 | | issuer, pharmacy benefits manager, or other third -party payor; or |
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527 | 527 | | 7. Exclude any 340B entity from the health insurance issuer, |
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528 | 528 | | pharmacy benefits manager, or other third -party payor network on the |
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529 | 529 | | basis that the 340B entity dispenses drugs subject to an a greement |
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530 | 530 | | under Section 256b of Title 42 of the United State Code , or refuse |
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531 | 531 | | to contract with a 340B entity for reasons other than those that |
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532 | 532 | | apply equally to non -340B entities. |
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533 | 533 | | B. Nothing in this section applies to the Oklahoma Medicaid |
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534 | 534 | | program as payor when Medicaid provides reimbursement for covered |
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535 | 535 | | outpatient drugs as defined in Section 1396r -8(k) of Title 42 of the |
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536 | 536 | | United States Code. |
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537 | 537 | | SECTION 4. NEW LAW A new section of law to be codified |
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538 | 538 | | in the Oklahoma Statutes as Section 5403 of Title 36, unless there |
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539 | 539 | | is created a duplication in numbering, reads as follows: |
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540 | 540 | | A manufacturer or distributor shall not: |
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541 | 541 | | 1. Deny, prohibit, condition, discriminate against, refuse, or |
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542 | 542 | | withhold 340B drug pricing for, or otherwise limit the dispensing, |
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543 | 543 | | purchase, ordering, delivery, or receipt of, a drug purchased to be |
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544 | 544 | | dispensed or administered under a contract pharmacy agreement; or |
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545 | 545 | | 2. Prohibit a pharmacy from contracting or participating with a |
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546 | 546 | | 340B entity by denying 340B pricing on, or the pharmacy ’s access to, |
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547 | 547 | | |
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598 | 598 | | a drug that is manufactured by a manufacturer based on a pharmacy ’s |
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599 | 599 | | relationship with a 340B entity. |
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600 | 600 | | SECTION 5. NEW LAW A new section of law to be codified |
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601 | 601 | | in the Oklahoma Statutes as Section 5404 of Title 36, unless there |
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602 | 602 | | is created a duplication in numbering, reads as follows: |
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603 | 603 | | The Attorney General may promulgate rules to effectuate the |
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604 | 604 | | provisions of this act and shall make recommendations to the |
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605 | 605 | | Insurance Commissioner for enforcement within the jurisdiction of |
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606 | 606 | | the Insurance Commissioner. In addition to or in lieu of any |
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607 | 607 | | applicable censure, suspension, or revocation of a license, a |
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608 | 608 | | manufacturer, distributor, health insurance issuer, pharmacy |
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609 | 609 | | benefits manager, other third -party payor, or its agent may be |
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610 | 610 | | subject to a civil fine not less than One Hundred Dollars ($100.00) |
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611 | 611 | | and not greater than Ten Thousand Dollars ($10,000.00) for each |
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612 | 612 | | violation of the provisions of this act. A violation occurs e ach |
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613 | 613 | | time a prohibited act is committed. |
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614 | 614 | | SECTION 6. NEW LAW A new section of law to be codified |
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615 | 615 | | in the Oklahoma Statutes as Section 5405 of Title 36, unless there |
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616 | 616 | | is created a duplication in numbering, reads as follows: |
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617 | 617 | | A. Nothing in this act shall be construed to be less |
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618 | 618 | | restrictive than federal law for a person or entity regulated by |
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619 | 619 | | this act. |
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620 | 620 | | B. Nothing in this act shall be construed to be in conflict |
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621 | 621 | | with applicable federal law and regulations or Oklahoma Statute s. |
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622 | 622 | | |
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672 | 672 | | |
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673 | 673 | | C. Limited distribution of a drug required under Section 355 -1 |
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674 | 674 | | of Title 21 of the United St ates Code shall not be construed as a |
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675 | 675 | | violation of this act. |
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676 | 676 | | SECTION 7. AMENDATORY 36 O.S. 2021, Section 6960, as |
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677 | 677 | | last amended by Section 1, Chapter 30 6, O.S.L. 2024 (36 O.S. Supp. |
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678 | 678 | | 2024, Section 6960), is amended to read as follows: |
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679 | 679 | | Section 6960. A. For purposes of the Patient ’s Right to |
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680 | 680 | | Pharmacy Choice Act: |
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681 | 681 | | 1. “Covered entity” means a nonprofit hospital or medical |
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682 | 682 | | service organization, for -profit hospital or medical service |
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683 | 683 | | organization, insurer, health benefit plan, health mai ntenance |
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684 | 684 | | organization, health program administered by the state in the |
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685 | 685 | | capacity of providing health coverage, or an employer, labor union, |
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686 | 686 | | or other group of persons that provide s health coverage to persons |
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687 | 687 | | in this state. This term does not include a health plan that |
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688 | 688 | | provides coverage only for accidental injury, specified disease, |
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689 | 689 | | hospital indemnity, disability income, or other limited benefit |
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690 | 690 | | health insurance policies and contra cts that do not include |
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691 | 691 | | prescription drug coverage; |
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692 | 692 | | 2. “Health insurer” means any corporation, association, benefit |
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693 | 693 | | society, exchange, partnership or individual licensed by the |
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694 | 694 | | Oklahoma Insurance Code; |
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695 | 695 | | 3. “Health insurer payor ” means a health insurance c ompany, |
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696 | 696 | | health maintenance organization, union, hospital and medical |
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697 | 697 | | |
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747 | 747 | | |
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748 | 748 | | services organization or any entity providing or administering a |
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749 | 749 | | self-funded health benefit plan; |
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750 | 750 | | 4. “Mail-order pharmacy” means a pharmacy licensed by this |
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751 | 751 | | state that primarily dispense s and delivers covered drugs via common |
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752 | 752 | | carrier; |
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753 | 753 | | 5. “Pharmacy benefits manager ” or “PBM” means a person, |
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754 | 754 | | business, or other entity that performs pharmacy benefits |
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755 | 755 | | management. The term shall include a person or entity acting on |
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756 | 756 | | behalf of a PBM in a contra ctual or employment relationship in the |
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757 | 757 | | performance of pharmacy benefits management for a managed care |
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758 | 758 | | company, nonprofit hospital, medical service organization, insurance |
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759 | 759 | | company, third-party payor or a health program administered by a |
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760 | 760 | | department of this state; |
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761 | 761 | | 6. “Pharmacy benefits management ” means a service provided to |
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762 | 762 | | covered entities to facilitate the provisions of prescription drug |
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763 | 763 | | benefits to covered individuals within the state, including, but not |
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764 | 764 | | limited to, negotiating pricing and other terms wi th drug |
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765 | 765 | | manufacturers and providers. Pharmacy benefits management may |
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766 | 766 | | include any or all of the following services: |
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767 | 767 | | a. claims processing, retail network management, and |
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768 | 768 | | payment of claims to pharmacies for prescription drugs |
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769 | 769 | | dispensed to covered individual s, |
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770 | 770 | | b. administration or management of pharmacy discount |
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771 | 771 | | cards or programs, |
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772 | 772 | | |
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773 | 773 | | |
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822 | 822 | | |
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823 | 823 | | c. clinical formulary development and management |
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824 | 824 | | services, or |
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825 | 825 | | d. rebate contracting and administration; |
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826 | 826 | | 7. “Provider” means a pharmacy, as defined in Section 353.1 of |
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827 | 827 | | Title 59 of the Oklahoma Statutes or an agent or representative of a |
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828 | 828 | | pharmacy; |
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829 | 829 | | 8. “Retail pharmacy network ” means retail pharmacy providers |
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830 | 830 | | contracted with a PBM in which the pharmacy primarily fills and |
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831 | 831 | | sells prescriptions via a retail, storefront location; |
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832 | 832 | | 9. “Rural service area” means a five-digit ZIP code in which |
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833 | 833 | | the population density is less than one thousand (1,000) individuals |
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834 | 834 | | per square mile; |
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835 | 835 | | 10. “Spread pricing” means a prescription drug pricing model |
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836 | 836 | | utilized by a pharmacy benefits manager in which the PB M charges a |
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837 | 837 | | health benefit plan a contracted price for prescription drugs that |
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838 | 838 | | differs from the amount the PBM directly or indirectly pays the |
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839 | 839 | | pharmacy or pharmacist for providing pharmacy services; |
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840 | 840 | | 11. “Suburban service area ” means a five-digit ZIP code in |
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841 | 841 | | which the population density is between one thousand (1,000) and |
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842 | 842 | | three thousand (3,000) individuals per square mile; and |
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843 | 843 | | 12. “Urban service area” means a five-digit ZIP code in which |
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844 | 844 | | the population density is greater than three thousand (3,000) |
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845 | 845 | | individuals per square mile ; |
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846 | 846 | | |
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847 | 847 | | |
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897 | 897 | | 13. “340B drug” means a drug that has been subject to any |
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898 | 898 | | reduced purchase price by a manufacturer pursuant to Section 256b of |
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899 | 899 | | Title 42 of the United States Code and is purchased by a covered |
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900 | 900 | | entity as defined in Section 256b(a)(4) o f Title 42 of the United |
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901 | 901 | | States Code; and |
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902 | 902 | | 14. “340B entity” means an entity pa rticipating or authorized |
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903 | 903 | | to participate in the federal 340B drug pricing program, as |
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904 | 904 | | described in Section 256b of Title 42 of the United States Code, |
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905 | 905 | | including its pharmacy, or any pharmacy contracted with the |
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906 | 906 | | participating entity to dispense drugs purchased through the 340B |
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907 | 907 | | drug pricing program . |
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908 | 908 | | B. Nothing in the definitions of pharmacy benefits manager or |
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909 | 909 | | pharmacy benefits management as such terms are defined in the |
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910 | 910 | | Patient’s Right to Pharmacy Choice Act, the Pharmacy Audit Integrity |
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911 | 911 | | Act, or Sections 357 through 360 of Title 59 of the Oklahoma |
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912 | 912 | | Statutes shall be construed to deem the following entities to be a |
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913 | 913 | | pharmacy benefits manager: |
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914 | 914 | | 1. An employer of its own self -funded health benefit plan, |
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915 | 915 | | except, to the extent permitted by applicable law, where the |
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916 | 916 | | employer without the utilization of a third party and unrelated to |
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917 | 917 | | the employer’s own pharmacy: |
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918 | 918 | | a. negotiates directly with drug manufacturers, |
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919 | 919 | | b. processes claims on behalf of its members, or |
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920 | 920 | | c. manages its own retail network of pharmacies; or |
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921 | 921 | | |
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922 | 922 | | |
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971 | 971 | | |
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972 | 972 | | 2. A pharmacy that provides a patient with a discount card or |
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973 | 973 | | program that is for exclusive use at the pharmacy offering the |
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974 | 974 | | discount. |
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975 | 975 | | SECTION 8. AMENDATORY 36 O.S. 2021, Section 6962, as |
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976 | 976 | | last amended by Section 2, Chapter 306, O.S.L. 2024 (36 O.S. Supp. |
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977 | 977 | | 2024, Section 6962), is amended to read as follows: |
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978 | 978 | | Section 6962. A. The Attorney General shall review and approve |
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979 | 979 | | retail pharmacy network access for all pharm acy benefits managers |
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980 | 980 | | (PBMs) to ensure compliance with Section 6961 of this tit le. |
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981 | 981 | | B. A PBM, or an agent of a PBM, shall not: |
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982 | 982 | | 1. Cause or knowingly permit the use of advertisement, |
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983 | 983 | | promotion, solicitation, representation, proposal or offer that is |
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984 | 984 | | untrue, deceptive or misleading; |
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985 | 985 | | 2. Charge a pharmacist or pharmacy a fee related to the |
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986 | 986 | | adjudication of a claim including without limitation a fee for: |
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987 | 987 | | a. the submission of a claim, |
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988 | 988 | | b. enrollment or participation in a retail pharmacy |
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989 | 989 | | network, or |
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990 | 990 | | c. the development or management of claims processing |
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991 | 991 | | services or claims payment services rel ated to |
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992 | 992 | | participation in a retail pharmacy network; |
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993 | 993 | | 3. Reimburse a pharmacy or pharmacist in the state an amount |
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994 | 994 | | less than the amount that the PBM reimburses a pharmacy owned b y or |
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995 | 995 | | under common ownership with a PBM for providing the same covered |
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996 | 996 | | |
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1047 | 1047 | | services. The reimbursement amount paid to the pharmacy shall be |
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1048 | 1048 | | equal to the reimbursement amount calculated on a per -unit basis |
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1049 | 1049 | | using the same generic product identifier or generic co de number |
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1050 | 1050 | | paid to the PBM-owned or PBM-affiliated pharmacy; |
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1051 | 1051 | | 4. Deny a provider the opportunity to participate in any |
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1052 | 1052 | | pharmacy network at preferred participation status if the provider |
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1053 | 1053 | | is willing to accept the terms and conditions that the PBM has |
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1054 | 1054 | | established for other providers as a condition of preferred network |
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1055 | 1055 | | participation status; |
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1056 | 1056 | | 5. Deny, limit or terminate a provider ’s contract based on |
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1057 | 1057 | | employment status of any employee who has an active license to |
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1058 | 1058 | | dispense, despite probation status, with the State Board of |
---|
1059 | 1059 | | Pharmacy; |
---|
1060 | 1060 | | 6. Retroactively deny or reduce reimbursement for a covered |
---|
1061 | 1061 | | service claim after returning a paid claim response as part of the |
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1062 | 1062 | | adjudication of the claim, unless: |
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1063 | 1063 | | a. the original claim was submitted fraudulently, or |
---|
1064 | 1064 | | b. to correct errors identified in an audit, so long as |
---|
1065 | 1065 | | the audit was conducted in compliance with Sections |
---|
1066 | 1066 | | 356.2 and 356.3 of Title 59 of the Oklahoma Statutes; |
---|
1067 | 1067 | | 7. Fail to make any payment due to a pharmacy or pharmacist for |
---|
1068 | 1068 | | covered services properly rendered in the event a PBM terminates a |
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1069 | 1069 | | provider from a pharmacy benefits manager network; |
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1070 | 1070 | | |
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1071 | 1071 | | |
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1120 | 1120 | | |
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1121 | 1121 | | 8. Conduct or practice spread pricing, as defined in Section |
---|
1122 | 1122 | | 6960 of this title, in this state; or |
---|
1123 | 1123 | | 9. Charge a pharmacist or pharmacy a fee related to |
---|
1124 | 1124 | | participation in a retail pharmacy network including but not limited |
---|
1125 | 1125 | | to the following: |
---|
1126 | 1126 | | a. an application fee, |
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1127 | 1127 | | b. an enrollment or participation fee, |
---|
1128 | 1128 | | c. a credentialing or re -credentialing fee, |
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1129 | 1129 | | d. a change of ownership fee, or |
---|
1130 | 1130 | | e. a fee for the development or management of claims |
---|
1131 | 1131 | | processing services or claims payment services ; |
---|
1132 | 1132 | | 10. Discriminate, offer lower reimbursemen t, or impose any |
---|
1133 | 1133 | | separate terms upon a provider on the basis that a provider |
---|
1134 | 1134 | | participates in 340B drug pricing; |
---|
1135 | 1135 | | 11. Require a provider to reverse, resubmit, or clarify a 340B |
---|
1136 | 1136 | | drug pricing claim after the initial adjudication unless these |
---|
1137 | 1137 | | actions are in normal course of pharmacy business and not related to |
---|
1138 | 1138 | | 340B drug pricing; |
---|
1139 | 1139 | | 12. Require a billing modifier to indicate that the drug or |
---|
1140 | 1140 | | claim is a 340B drug pricing claim, unless th e drug or claim is |
---|
1141 | 1141 | | being billed to the Oklahoma Medicaid program; |
---|
1142 | 1142 | | 13. Modify a patient copayment on the basis that the provider |
---|
1143 | 1143 | | of the patient participates in 340B drug pricing; |
---|
1144 | 1144 | | |
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1145 | 1145 | | |
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1146 | 1146 | | Req. No. 596 Page 16 1 |
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1194 | 1194 | | |
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1195 | 1195 | | 14. Exclude a provider from a network on the basis that the |
---|
1196 | 1196 | | provider participates in 340B drug pricing; |
---|
1197 | 1197 | | 15. Establish or set network adequacy requirements based on |
---|
1198 | 1198 | | 340B drug pricing participation by a provider; |
---|
1199 | 1199 | | 16. Prohibit a 340B entity or a pharmacy under contract with a |
---|
1200 | 1200 | | 340B entity from participating in the network of the PBM on the |
---|
1201 | 1201 | | basis of participation in 340B drug pricing; or |
---|
1202 | 1202 | | 17. Base the drug form ulary or drug coverage decisions upon the |
---|
1203 | 1203 | | 340B drug pricing status of a drug, including price or availability, |
---|
1204 | 1204 | | or whether a dispensing pharmacy participates in 340B drug pricing . |
---|
1205 | 1205 | | C. The prohibitions under this section shall apply to contracts |
---|
1206 | 1206 | | between pharmacy benefits managers and providers for participation |
---|
1207 | 1207 | | in retail pharmacy networks. |
---|
1208 | 1208 | | 1. A PBM contract shall: |
---|
1209 | 1209 | | a. not restrict, directly or indirectly, any pharmacy |
---|
1210 | 1210 | | that dispenses a prescription drug from informing, or |
---|
1211 | 1211 | | penalize such pharmacy for informing, an individual of |
---|
1212 | 1212 | | any differential between the individual ’s out-of- |
---|
1213 | 1213 | | pocket cost or coverage with respect to acquisition of |
---|
1214 | 1214 | | the drug and the amount an individual would pay to |
---|
1215 | 1215 | | purchase the drug directly, and |
---|
1216 | 1216 | | b. ensure that any entity that provides pharmacy benefits |
---|
1217 | 1217 | | management services under a contract with any such |
---|
1218 | 1218 | | health plan or health insurance coverage does not, |
---|
1219 | 1219 | | |
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1220 | 1220 | | |
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1269 | 1269 | | |
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1270 | 1270 | | with respect to such plan or coverage, restrict, |
---|
1271 | 1271 | | directly or indirect ly, a pharmacy that dispenses a |
---|
1272 | 1272 | | prescription drug from informing, or penalize s uch |
---|
1273 | 1273 | | pharmacy for informing, a covered individual of any |
---|
1274 | 1274 | | differential between the individual ’s out-of-pocket |
---|
1275 | 1275 | | cost under the plan or coverage with respect to |
---|
1276 | 1276 | | acquisition of the dr ug and the amount an individual |
---|
1277 | 1277 | | would pay for acquisition of the drug without using |
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1278 | 1278 | | any health plan or health insurance coverage ., and |
---|
1279 | 1279 | | c. eliminate discriminatory contracting as it relates to: |
---|
1280 | 1280 | | (1) transferring the benefit of 340B drug pricing |
---|
1281 | 1281 | | savings from a 340B entity to another entity, |
---|
1282 | 1282 | | including without limitation pharmacy benefits |
---|
1283 | 1283 | | managers, private insurers, and managed care |
---|
1284 | 1284 | | organizations, |
---|
1285 | 1285 | | (2) offering a lower reimbursement rate for drugs |
---|
1286 | 1286 | | purchased under 340B drug pricing than for the |
---|
1287 | 1287 | | same drug not purchased under 340B drug pricing, |
---|
1288 | 1288 | | (3) refusal to cover drug purchases utilizing 340B |
---|
1289 | 1289 | | drug pricing, |
---|
1290 | 1290 | | (4) refusal to allow providers who utilize 340B drug |
---|
1291 | 1291 | | pricing to participate in networks, and |
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1292 | 1292 | | |
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1293 | 1293 | | |
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1342 | 1342 | | |
---|
1343 | 1343 | | (5) charging more than fair market value or seeking |
---|
1344 | 1344 | | profit sharing in exchange for services involving |
---|
1345 | 1345 | | 340B drug pricing. |
---|
1346 | 1346 | | 2. A pharmacy benefits ma nager’s contract with a provider shall |
---|
1347 | 1347 | | not prohibit, restrict, or limit disclosure of information or |
---|
1348 | 1348 | | documents to the Attorney General, law enforcement or state and |
---|
1349 | 1349 | | federal governmental officials investigating or examining a |
---|
1350 | 1350 | | complaint or conducting a review of a pharmacy benefits manager ’s |
---|
1351 | 1351 | | compliance with the requirements under the Patient ’s Right to |
---|
1352 | 1352 | | Pharmacy Choice Act, the Pharmacy Audit Integrity Act, and Sections |
---|
1353 | 1353 | | 357 through 360 of Title 59 of the Oklahoma Statutes. |
---|
1354 | 1354 | | D. A pharmacy benefits manager shall : |
---|
1355 | 1355 | | 1. Establish and maintain an electronic claim inquiry |
---|
1356 | 1356 | | processing system using the National Council for Prescription Drug |
---|
1357 | 1357 | | Programs’ current standards to communicate informatio n to pharmacies |
---|
1358 | 1358 | | submitting claim inquiries; |
---|
1359 | 1359 | | 2. Fully disclose to insurers, self -funded employers, unions or |
---|
1360 | 1360 | | other PBM clients the existence of the respective aggregate |
---|
1361 | 1361 | | prescription drug discounts, rebates received from drug |
---|
1362 | 1362 | | manufacturers and pharmacy audi t recoupments; |
---|
1363 | 1363 | | 3. Provide the Attorney General, insurers, self -funded employer |
---|
1364 | 1364 | | plans and unions unrestricted audit rights of and access to the |
---|
1365 | 1365 | | respective PBM pharmaceutical manufacturer and provider contracts, |
---|
1366 | 1366 | | |
---|
1367 | 1367 | | |
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1416 | 1416 | | |
---|
1417 | 1417 | | plan utilization data, plan pricing data, pha rmacy utilization data |
---|
1418 | 1418 | | and pharmacy pricing data; |
---|
1419 | 1419 | | 4. Maintain, for no less than three (3) years, documentation of |
---|
1420 | 1420 | | all network development activities including but not limited to |
---|
1421 | 1421 | | contract negotiations and any denials to providers to join networks. |
---|
1422 | 1422 | | This documentation shall be made available to the Attorney General |
---|
1423 | 1423 | | upon request; and |
---|
1424 | 1424 | | 5. Report to the Attorney General, on a quarterly basis for |
---|
1425 | 1425 | | each health insurer payor, on the following information: |
---|
1426 | 1426 | | a. the aggregate amount of rebates received by the PBM, |
---|
1427 | 1427 | | b. the aggregate amount of rebates distributed to the |
---|
1428 | 1428 | | appropriate health insurer payor, |
---|
1429 | 1429 | | c. the aggregate amount of rebates passed on to the |
---|
1430 | 1430 | | enrollees of each health insurer payor at the point of |
---|
1431 | 1431 | | sale that reduced the applicable deductible, |
---|
1432 | 1432 | | copayment, coinsure or other cost sharing amount of |
---|
1433 | 1433 | | the enrollee, |
---|
1434 | 1434 | | d. the individual and aggregate a mount paid by the health |
---|
1435 | 1435 | | insurer payor to the PBM for pharmacy services |
---|
1436 | 1436 | | itemized by pharmacy, drug product and service |
---|
1437 | 1437 | | provided, and |
---|
1438 | 1438 | | e. the individual and aggregate amount a PBM paid a |
---|
1439 | 1439 | | provider for pharmacy services itemized by pharmacy, |
---|
1440 | 1440 | | drug product and service provided ; and |
---|
1441 | 1441 | | |
---|
1442 | 1442 | | |
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1491 | 1491 | | |
---|
1492 | 1492 | | 6. Make drug formulary and coverage decisions based on the |
---|
1493 | 1493 | | normal course of business of the PBM, not based upon the 340B drug |
---|
1494 | 1494 | | pricing status of a drug, inc luding price or availability, or |
---|
1495 | 1495 | | whether a dispensing pharmacy participates in 340B drug pricing. |
---|
1496 | 1496 | | E. Nothing in the Patient ’s Right to Pharmacy Choice Act shall |
---|
1497 | 1497 | | prohibit the Attorney General from requesting and obtaining detailed |
---|
1498 | 1498 | | data, including raw data, in response to the information provided by |
---|
1499 | 1499 | | a PBM in the quarterly reports required by this section. The |
---|
1500 | 1500 | | Attorney General may alter the frequency of the reports required by |
---|
1501 | 1501 | | this section at his or her sole discretion. |
---|
1502 | 1502 | | F. The Attorney General may promulgat e rules to implement the |
---|
1503 | 1503 | | provisions of the Patient ’s Right to Pharmacy Choice A ct, the |
---|
1504 | 1504 | | Pharmacy Audit Integrity Act, and Sections 357 through 360 of Title |
---|
1505 | 1505 | | 59 of the Oklahoma Statutes. |
---|
1506 | 1506 | | SECTION 9. AMENDATORY Section 3, Chapter 38, O .S.L. |
---|
1507 | 1507 | | 2022, as last amended by Section 4, Chapter 306, O.S.L. 2024 (36 |
---|
1508 | 1508 | | O.S. Supp. 2024, Section 6966.1), is amended to read as follows: |
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1509 | 1509 | | Section 6966.1. A. The Insurance Commissioner may censure, |
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1510 | 1510 | | suspend, revoke, or refuse to issue or renew a license of o r levy a |
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1511 | 1511 | | civil penalty against any person licensed under the insurance laws |
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1512 | 1512 | | of this state for any violation of the Patient ’s Right to Pharmacy |
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1513 | 1513 | | Choice Act, Section 6958 et seq. of this title. |
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1514 | 1514 | | B. 1. If the Attorney General finds, after notice and |
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1515 | 1515 | | opportunity for hearing, that a pharmacy benefits manager (PBM) |
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1566 | 1566 | | |
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1567 | 1567 | | violated one or more provisions of the Patient ’s Right to Pharmacy |
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1568 | 1568 | | Choice Act, the Pharmacy Audit Integrity Act or the provisions of |
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1569 | 1569 | | Sections 357 through 360 of Title 59 of the Oklahoma Statutes, the |
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1570 | 1570 | | Attorney General may instruct the Insurance Commissioner that the |
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1571 | 1571 | | PBM be censured or his or her license be suspended or revoked. If |
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1572 | 1572 | | the Attorney General makes such instruction, the Commissioner shall |
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1573 | 1573 | | enforce such action within thirty (30) days. |
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1574 | 1574 | | 2. In addition to or in lieu of any censure or suspension or |
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1575 | 1575 | | revocation of a license by the Commissioner, the Attorney General |
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1576 | 1576 | | may levy a civil or administrative fine not less than One Hundred |
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1577 | 1577 | | Dollars ($100.00) and not greater than Ten Thousand Dollars |
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1578 | 1578 | | ($10,000.00) for each violation of the provisions of the Patient ’s |
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1579 | 1579 | | Right to Pharmacy Choice Act, the Pharmacy Audit Integrity Act or |
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1580 | 1580 | | the provisions of Sections 357 through 360 of Title 59 of the |
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1581 | 1581 | | Oklahoma Statutes. |
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1582 | 1582 | | 3. The Attorney General may order restitution for econ omic loss |
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1583 | 1583 | | suffered by pharmacies or patients for violations of the Patient ’s |
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1584 | 1584 | | Right to Pharmacy Choice Act, the Pharmacy Audit Integrity Act, or |
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1585 | 1585 | | the provisions of Sections 357 through 360 of Title 59 of the |
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1586 | 1586 | | Oklahoma Statutes. |
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1587 | 1587 | | C. Notwithstanding whether the license of a PBM has been |
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1588 | 1588 | | issued, suspended, revoked, surrendered or lapsed by operation of |
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1589 | 1589 | | law, the Attorney General is hereby authorized to enforce the |
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1590 | 1590 | | provisions of the Patient ’s Right to Pharmacy Choice Act and impose |
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1591 | 1591 | | |
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1592 | 1592 | | |
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1641 | 1641 | | |
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1642 | 1642 | | any penalty or remedy authorized under the act against a PBM under |
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1643 | 1643 | | investigation for or charged with a violation of the Patient ’s Right |
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1644 | 1644 | | to Pharmacy Choice Act, the Pharmacy Audit Integrity Act, the |
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1645 | 1645 | | provisions of Sections 357 through 360 of Title 59 of the Oklahoma |
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1646 | 1646 | | Statutes or any provisio n of the insurance laws of this state. |
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1647 | 1647 | | D. Each day that a PBM conducts busines s in this state without |
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1648 | 1648 | | a license from the Insurance Department shall be deemed a violation |
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1649 | 1649 | | of the Patient’s Right to Pharmacy Choice Act. |
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1650 | 1650 | | E. 1. All hearings conducted by the Office of the Attorney |
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1651 | 1651 | | General pursuant to this section shall be public and held in |
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1652 | 1652 | | accordance with the Administrative Procedures Act. |
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1653 | 1653 | | 2. Hearings shall be held at the Office of the Attorney General |
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1654 | 1654 | | or any other place the Attorney General may deem conveni ent. |
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1655 | 1655 | | 3. The Attorney General, upon written request from a PBM |
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1656 | 1656 | | affected by the hearing, shall cause a full stenographic record of |
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1657 | 1657 | | the proceedings to be made by a competent court reporter. This |
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1658 | 1658 | | record shall be at the expense of the PBM. |
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1659 | 1659 | | 4. The ordinary fees and costs of the hearing examiner |
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1660 | 1660 | | appointed pursuant to Section 319 of this title may be assessed by |
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1661 | 1661 | | the hearing examiner against the respondent unless the respondent is |
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1662 | 1662 | | the prevailing party. |
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1663 | 1663 | | F. Any PBM whose license has been censured, suspended, revok ed |
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1664 | 1664 | | or denied renewal or who has had a fine levied against him or her |
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1665 | 1665 | | shall have the right of appeal from the final order of the Attorney |
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1666 | 1666 | | |
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1667 | 1667 | | |
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1668 | 1668 | | Req. No. 596 Page 23 1 |
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1716 | 1716 | | |
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1717 | 1717 | | General, pursuant to Section 318 et seq. of Title 75 of the Oklahoma |
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1718 | 1718 | | Statutes. |
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1719 | 1719 | | G. If the Attorney General determines, based upon an |
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1720 | 1720 | | investigation of complaints, that a PBM has engaged in violations of |
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1721 | 1721 | | the provisions of the Patient ’s Right to Pharmacy Choice Act, the |
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1722 | 1722 | | Pharmacy Audit Integrity Act, and Sections 357 through 360 of Title |
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1723 | 1723 | | 59 of the Oklahoma Statutes with such f requency as to indicate a |
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1724 | 1724 | | general business practice, and that the PBM should be subjected to |
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1725 | 1725 | | closer supervision with respect to those practices, the Attorney |
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1726 | 1726 | | General may require the PBM to file a report at any periodic |
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1727 | 1727 | | interval the Attorney General deems n ecessary. |
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1728 | 1728 | | H. 1. The Attorney General shall have the authority to collect |
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1729 | 1729 | | all fines, penalties, restitution, and interest thereon pursuant to |
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1730 | 1730 | | the provisions of the Patient ’s Right to Pharmacy Choice Act, the |
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1731 | 1731 | | Pharmacy Audit Integrity Act, and the provision s of Sections 357 |
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1732 | 1732 | | through 360 of Title 59 of the Oklahoma Statutes, or any othe r |
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1733 | 1733 | | charge, cause of action, prelitigation settlement, or other |
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1734 | 1734 | | settlement that requires the recovery of money as a result of |
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1735 | 1735 | | violations of the Patient ’s Right to Pharmacy Choice Act. Funds |
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1736 | 1736 | | collected by the Attorney General pursuant to the Patient ’s Right to |
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1737 | 1737 | | Pharmacy Choice Act, the Pharmacy Audit Integrity Act, and Sections |
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1738 | 1738 | | 357 through 360 of Title 59 of the Oklahoma Statutes shall be |
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1739 | 1739 | | deposited into the Attorney General ’s Pharmacy Benefits Manager |
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1740 | 1740 | | Enforcement Revolving Fund created in Section 5 of this act. |
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1741 | 1741 | | |
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1742 | 1742 | | |
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1791 | 1791 | | |
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1792 | 1792 | | 2. Costs of investigation, litigation, attorney fees, and other |
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1793 | 1793 | | expenses incurred shall be retained by the Office of the Attorney |
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1794 | 1794 | | General. Remaining funds shall be distribute d to pharmacists, |
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1795 | 1795 | | patients, or other injured parties as determined by the Attorney |
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1796 | 1796 | | General. |
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1797 | 1797 | | 3. The Attorney General shall promulgate rules for the |
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1798 | 1798 | | distribution of funds pursuant to this subsection. |
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1799 | 1799 | | I. All claims processed by a PBM on behalf of a provider that |
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1800 | 1800 | | participates in 340B drug pricing or on behalf of a 340B entity |
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1801 | 1801 | | shall be deemed final at the point of adjudication. |
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1802 | 1802 | | SECTION 10. This act shall become effective November 1, 2025. |
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1803 | 1803 | | |
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1804 | 1804 | | 60-1-596 CAD 1/16/2025 2:29:23 PM |
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