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44 | 43 | | |
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45 | 44 | | |
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46 | 45 | | |
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47 | 46 | | COMMITTEE SUBSTITUTE |
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48 | 47 | | |
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49 | 48 | | An Act relating to pharmacy benefit s managers; |
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50 | 49 | | amending 59 O.S. 2021, Sections 356.1, 356.2, 356.3, |
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51 | 50 | | as amended by Sections 1, 2, and 3, Chapter 332, |
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52 | 51 | | O.S.L. 2024, and 356.4 (59 O.S. Supp. 2024, Sections |
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53 | 52 | | 356.1, 356.2, and 356.3), which relate to |
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54 | 53 | | definitions, pharmacy audit requirements, appeals |
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55 | 54 | | process, and prohibited extrapolation audit; |
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56 | 55 | | modifying notice contents; prohibiting assessment of |
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57 | 56 | | certain fines under certain circumstances; expanding |
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58 | 57 | | certain claim limits; establishing requirements for |
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59 | 58 | | preliminary audit findings reports; requiring |
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60 | 59 | | provision of certain final audit results within a |
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61 | 60 | | certain time period; updating statutory reference; |
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62 | 61 | | requiring certain notification to Attorney General in |
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63 | 62 | | certain circumstances; expanding requirement for |
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64 | 63 | | initiation of certain audit; lengthening time period |
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65 | 64 | | for certain preliminary report; allowing certain |
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66 | 65 | | extension request; shortening certain time period for |
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67 | 66 | | certain final report; establishing requirements for |
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68 | 67 | | audit findings report; modifying definition; defining |
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69 | 68 | | terms; requiring certain tolling in certain declared |
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70 | 69 | | disaster; providing certain exceptions; amending 59 |
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71 | 70 | | O.S. 2021, Sections 357, 358, and 360 , as amended by |
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72 | 71 | | Sections 4, 5, and 6, Chapter 332, O.S.L. 2024 (59 |
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73 | 72 | | O.S. Supp. 2024, Sections 357, 358, and 360), which |
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74 | 73 | | relate to definitions, pharmacy benefits management |
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75 | 74 | | licensure, and pharmacy benefits manager contractual |
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103 | 101 | | duties; modifying notice contents; defining terms; |
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104 | 102 | | updating statutory references; requiring certain time |
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105 | 103 | | period of tolling in certain declared disaster; |
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106 | 104 | | requiring certain documented proof by certain |
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107 | 105 | | pharmacy benefits managers; establishing certain |
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108 | 106 | | denial for certain appeals; prohibiting certain |
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109 | 107 | | collection of additional monies by certain pharmacy |
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110 | 108 | | benefits managers; establishing certain filing period |
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111 | 109 | | after lifting of disaster declaration; prohibiting |
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112 | 110 | | certain denials; updating statutory language; |
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113 | 111 | | providing for codification; and declaring an |
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114 | 112 | | emergency. |
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118 | 116 | | |
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119 | 117 | | BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA: |
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120 | 118 | | SECTION 1. AMENDATORY 59 O.S. 2021, Section 356.1, as |
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121 | 119 | | amended by Section 1, Chapter 332, O.S.L. 2024 (59 O.S. Supp. 2024, |
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122 | 120 | | Section 356.1), is amended to read as follows: |
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123 | 121 | | Section 356.1. A. For purposes of the Pharmacy Audit Integrity |
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124 | 122 | | Act, “pharmacy benefits manager” : |
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125 | 123 | | 1. “Audit” means any review, inspection, or analysis conducted |
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126 | 124 | | by a pharmacy benefits manager (PBM) or its representative of a |
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127 | 125 | | pharmacy’s records, practices, or compliance with contractual |
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128 | 126 | | obligations; |
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129 | 127 | | 2. “Disaster declaration” and “declared disaster” mean a |
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130 | 128 | | declaration issued by the Governor or the President of the United |
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131 | 129 | | States for an event that qualifies as a disaster including, but not |
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132 | 130 | | limited to, a flood, tornado, earthquake, wildfire, terrorist |
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133 | 131 | | attack, or other catastrophic event; and |
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161 | 158 | | 3. “Pharmacy benefits manager” or “PBM” shall have the same |
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162 | 159 | | meaning as in Section 6960 of Title 36 of the Oklahoma Statutes. |
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163 | 160 | | B. The purpose of the Pharmacy Audit Integrity Act is to |
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164 | 161 | | establish minimum and uniform standards and criteria for the audit |
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165 | 162 | | of pharmacy records by or on behalf of certain entities. |
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166 | 163 | | C. The Pharmacy Audit In tegrity Act shall apply to any audit of |
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167 | 164 | | the records of a pharmacy conducted by a managed care company, |
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168 | 165 | | nonprofit hospital, medical service organization, insurance company, |
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169 | 166 | | third-party payor, pharmacy benefits manager, a health program |
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170 | 167 | | administered by a dep artment of this state, or any entity that |
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171 | 168 | | represents these companies, groups, or departments. |
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172 | 169 | | D. The Attorney General may promulgate rules to implement the |
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173 | 170 | | provisions of the Pharmacy Audit Integrity Act. |
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174 | 171 | | SECTION 2. AMENDATORY 59 O.S. 2021, Section 356.2, as |
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175 | 172 | | amended by Section 2, Chapter 332, O.S.L. 2024 (59 O.S. Supp. 2024, |
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176 | 173 | | Section 356.2), is amended to read as follows: |
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177 | 174 | | Section 356.2. A. The entity conducting an audit of a pharmacy |
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178 | 175 | | shall: |
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179 | 176 | | 1. Identify and specifically describe t he audit and appeal |
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180 | 177 | | procedures in the pharmacy contract. Prescription claim |
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181 | 178 | | documentation and record-keeping recordkeeping requirements shall |
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182 | 179 | | not exceed the requirements set forth by the Oklahoma Pharmacy Act |
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183 | 180 | | or other applicable state or federal laws or r egulations; |
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211 | 207 | | 2. Give the pharmacy written notice by certified letter to the |
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212 | 208 | | pharmacy and the pharmacy’s contracting agent, including |
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213 | 209 | | identification of specific prescription numbers and, fill dates, |
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214 | 210 | | drug names, and National Drug Code (NDC) numbers to be audited, at |
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215 | 211 | | least fourteen (14) calendar days prior to conducting the audit, |
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216 | 212 | | including, but not limited to, an on -site audit, a desk audit, or a |
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217 | 213 | | wholesale purchase audit, request for documentation related to the |
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218 | 214 | | dispensing of a prescription drug , or any reimbursed activity by a |
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219 | 215 | | pharmacy provider; provided, however, that wholesale purchase audits |
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220 | 216 | | shall require a minimum of thirty (30) calendar days’ written |
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221 | 217 | | notice. For an on-site audit, the audit date shall be the date the |
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222 | 218 | | on-site audit occurs. For all other audit types, the audit date |
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223 | 219 | | shall be the date the pharmacy provides the documentation requested |
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224 | 220 | | in the audit notice. The pharmacy shall have the opportunity to |
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225 | 221 | | reschedule the audit no more than seven (7) calendar days from the |
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226 | 222 | | date designated on the origi nal audit notification; |
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227 | 223 | | 3. Not interfere with the delivery of pharmacist services to a |
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228 | 224 | | patient and shall utilize every reasonable effort to minimize |
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229 | 225 | | inconvenience and disruption to pharmacy operations during the audit |
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230 | 226 | | process; |
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231 | 227 | | 4. Conduct any audit involv ing clinical or professional |
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232 | 228 | | judgment by means of or in consultation with a licensed pharmacist; |
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233 | 229 | | 5. Not consider as fraud any clerical or record-keeping |
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234 | 230 | | recordkeeping error, such as a typographical error, scrivener’s |
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261 | 256 | | |
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262 | 257 | | error or computer error, including, bu t not limited to, a |
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263 | 258 | | miscalculated day supply, incorrectly billed prescription written |
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264 | 259 | | date or prescription origin code, and such errors shall not be |
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265 | 260 | | subject to recoupment. The pharmacy shall have the right to submit |
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266 | 261 | | amended claims electronically to correc t clerical or record-keeping |
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267 | 262 | | recordkeeping errors in lieu of recoupment. To the extent that an |
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268 | 263 | | audit results in the identification of any clerical or record- |
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269 | 264 | | keeping recordkeeping errors such as typographical errors, |
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270 | 265 | | scrivener’s errors or computer errors i n a required document or |
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271 | 266 | | record, the pharmacy shall not be subject to recoupment of funds by |
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272 | 267 | | the pharmacy benefits manager unless the pharmacy benefits manager |
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273 | 268 | | can provide proof of intent to commit fraud. A person shall not be |
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274 | 269 | | subject to criminal penaltie s for errors provided for in this |
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275 | 270 | | paragraph without proof of intent to commit fraud; |
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276 | 271 | | 6. Permit a pharmacy to use the records of a hospital, |
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277 | 272 | | physician, or other authorized practitioner of the healing arts for |
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278 | 273 | | drugs or medicinal supplies written or transmit ted by any means of |
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279 | 274 | | communication for purposes of validating the pharmacy record with |
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280 | 275 | | respect to orders or refills of a legend or narcotic drug; |
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281 | 276 | | 7. Not include the dispensing fee amount or the actual invoice |
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282 | 277 | | cost of the prescription dispensed in a finding of an audit |
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283 | 278 | | recoupment unless a prescription was not actually dispensed or a |
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284 | 279 | | physician denied authorization of a dispensing order; |
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311 | 305 | | |
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312 | 306 | | 8. Audit each pharmacy under identical standards, regularity |
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313 | 307 | | and parameters as other similarly situated pharmacies and all |
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314 | 308 | | pharmacies owned or managed by the pharmacy benefits manager |
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315 | 309 | | conducting or having conducted the audit; |
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316 | 310 | | 9. Not exceed one (1) year from the date the claim was |
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317 | 311 | | submitted to or adjudicated by a managed care company, nonprofit |
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318 | 312 | | hospital or medical service orga nization, insurance company, third- |
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319 | 313 | | party payor, pharmacy benefits manager, a health program |
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320 | 314 | | administered by a department of this state, or any entity that |
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321 | 315 | | represents the companies, groups, or departments for the period |
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322 | 316 | | covered by an audit; |
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323 | 317 | | 10. Not schedule or initiate an audit during the first seven |
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324 | 318 | | (7) calendar days of any month unless otherwise consented to by the |
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325 | 319 | | pharmacy; |
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326 | 320 | | 11. Disclose to any plan sponsor whose claims were included in |
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327 | 321 | | the audit any money recouped in the audit; |
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328 | 322 | | 12. Not require pharmaci sts to break open packaging labeled |
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329 | 323 | | “for single-patient-use only”. Packaging labeled “for single - |
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330 | 324 | | patient-use only” shall be deemed to be the smallest package size |
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331 | 325 | | available; and |
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332 | 326 | | 13. Upon recoupment of funds from a pharmacy, refund first to |
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333 | 327 | | the patient the portion of the recovered funds that were originally |
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334 | 328 | | paid by the patient, provided such funds were part of the |
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335 | 329 | | recoupment; and |
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363 | 356 | | 14. Not assess a fine, penalty, or any other financial |
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364 | 357 | | requirement on the pharmacy or pharmacist for any prescription |
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365 | 358 | | audited unless there is a valid recoupment under the Pharmacy Audit |
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366 | 359 | | Integrity Act. |
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367 | 360 | | B. 1. Any entity that conducts wholesale purchase review |
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368 | 361 | | during an audit of a pharmacist or pharmacy shall not require the |
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369 | 362 | | pharmacist or pharmacy to provide a full dispensing repor t. |
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370 | 363 | | Wholesaler invoice reviews shall be limited to verification of |
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371 | 364 | | purchase inventory specific to the pharmacy claims paid by the |
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372 | 365 | | health benefits plan or pharmacy benefits manager conducting the |
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373 | 366 | | audit. |
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374 | 367 | | 2. Any entity conducting an audit shall not identify or label a |
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375 | 368 | | prescription claim as an audit discrepancy when: |
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376 | 369 | | a. the National Drug Code for the dispensed drug is in a |
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377 | 370 | | quantity that is a subunit or multiple of the drug |
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378 | 371 | | purchased by the pharmacist or pharmacy as supported |
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379 | 372 | | by a wholesale invoice, |
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380 | 373 | | b. the pharmacist or pharmacy dispensed the correct |
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381 | 374 | | quantity of the drug according to the prescription, |
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382 | 375 | | and |
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383 | 376 | | c. the drug dispensed by the pharmacist or pharmacy |
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384 | 377 | | shares all but the last two digits of the National |
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385 | 378 | | Drug Code of the drug reflected on the supplier |
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386 | 379 | | invoice. |
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414 | 406 | | 3. An entity conducting an audit shall accept as evidence, |
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415 | 407 | | subject to validation, to support the validity of a pharmacy claim |
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416 | 408 | | related to a dispensed drug: |
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417 | 409 | | a. redacted copies of supplier invoices in the |
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418 | 410 | | pharmacist’s or pharmacy’s possession, or |
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419 | 411 | | b. invoices and any supporting documents from any |
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420 | 412 | | supplier as authorized by federal or state law to |
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421 | 413 | | transfer ownership of the drug acquired by the |
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422 | 414 | | pharmacist or pharmacy. |
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423 | 415 | | 4. An entity conducting an audit shall provide, no later than |
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424 | 416 | | five (5) calendar days after the date of a request by the pharmacist |
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425 | 417 | | or pharmacy, all supporting documents the pharmacist’s or pharmacy’s |
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426 | 418 | | purchase suppliers provided to the health benefits plan issuer or |
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427 | 419 | | pharmacy benefits manager. |
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428 | 420 | | C. A pharmacy shall be allowed to provide the pharmacy’s |
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429 | 421 | | computerized patterned medical records or the records of a hospital, |
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430 | 422 | | physician, or other authorized practitioner of the healing arts for |
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431 | 423 | | drugs or medicinal supplies written or transmitted by any means of |
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432 | 424 | | communication for purposes of supporting the pharma cy record with |
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433 | 425 | | respect to orders or refills of a legend or narcotic drug. |
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434 | 426 | | D. The entity conducting the audit shall not audit more than |
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435 | 427 | | fifty prescriptions, with specific date of service, per calendar |
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436 | 428 | | year PBM or its agent shall not exceed an annual limit of fifty |
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437 | 429 | | prescription claims with a specific prescription number and date of |
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464 | 455 | | |
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465 | 456 | | fill per calendar year . The annual limit to the number of |
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466 | 457 | | prescription claims audited shall be inclusive of all audits by a |
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467 | 458 | | PBM or its agent, including any prescription -related documentation |
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468 | 459 | | requests from the health insurer, pharmacy benefits manager or any |
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469 | 460 | | third-party company conducting audits on behalf of any health |
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470 | 461 | | insurer or pharmacy benefits manager during a calendar year. |
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471 | 462 | | E. If paper copies of records are requested by the e ntity |
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472 | 463 | | conducting the audit, the entity shall pay twenty -five cents ($0.25) |
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473 | 464 | | per page to cover the costs incurred by the pharmacy. The entity |
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474 | 465 | | conducting the audit shall provide the pharmacy with accurate |
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475 | 466 | | instructions, including any required form for obtaini ng |
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476 | 467 | | reimbursement for the copied records. |
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477 | 468 | | F. The entity conducting the audit shall: |
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478 | 469 | | 1. Deliver a preliminary audit findings report to the pharmacy |
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479 | 470 | | and the pharmacy’s contracting agent within forty -five (45) calendar |
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480 | 471 | | days of conducting the audit; |
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481 | 472 | | 2. Allow the pharmacy at least ninety (90) calendar days |
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482 | 473 | | following receipt of the preliminary audit findings report in which |
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483 | 474 | | to produce documentation to address any discrepancy found during the |
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484 | 475 | | audit; provided, however, a pharmacy may request an extension, not |
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485 | 476 | | to exceed an additional forty-five (45) calendar days; |
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486 | 477 | | 3. Deliver a final audit findings report to the pharmacy and |
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487 | 478 | | the pharmacy’s contracting agent signed by the auditor within ten |
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488 | 479 | | (10) calendar days after receipt of additional documentation |
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515 | 505 | | |
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516 | 506 | | provided by the pharmacy, as provided for in Section 356.3 of this |
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517 | 507 | | title; |
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518 | 508 | | 4. Allow the pharmacy to reverse and resubmit claims |
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519 | 509 | | electronically within thirty (30) calendar days of receipt of the |
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520 | 510 | | final audit report in lieu of the auditing entity recouping |
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521 | 511 | | discrepant claim amounts from the pharmacy; |
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522 | 512 | | 5. Not recoup any disputed funds until after final disposition |
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523 | 513 | | of the audit findings, including the appeals process as provided for |
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524 | 514 | | in Section 356.3 of this title; and |
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525 | 515 | | 6. Not accrue interest during the audit and appeal period ; |
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526 | 516 | | 7. Ensure that each preliminary audit findings report required |
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527 | 517 | | by this section includes: |
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528 | 518 | | a. specific prescription numbers, fill dates, drug names, |
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529 | 519 | | and NDC numbers, and |
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530 | 520 | | b. the date of receipt of documents from the pharmacy, |
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531 | 521 | | the pharmacy’s contracting agent , or any other source |
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532 | 522 | | associated with the audit . |
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533 | 523 | | G. Each entity conducting an audit shall provide a copy of the |
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534 | 524 | | final audit results, and a final audit report upon request, after |
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535 | 525 | | completion of any review process to the plan sponsor |
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536 | 526 | | In addition to the requi rements for a preliminary audit findings |
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537 | 527 | | report in this paragraph, the final audit findings report shall |
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538 | 528 | | include any additional documentation that was submitted to the |
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539 | 529 | | auditing entity; |
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540 | 530 | | |
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543 | 532 | | 2 |
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563 | 552 | | 22 |
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564 | 553 | | 23 |
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565 | 554 | | 24 |
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566 | 555 | | |
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567 | 556 | | 8. Provide the plan sponsor a copy of the final audit results |
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568 | 557 | | within thirty (30) calendar days of the final disposition of the |
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569 | 558 | | audit; and |
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570 | 559 | | 9. At the request of the plan sponsor, provide a copy of the |
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571 | 560 | | final audit findings report within thirty (30) calendar days of the |
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572 | 561 | | request. |
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573 | 562 | | H. G. 1. The full amount of any recoupment on a n audit shall |
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574 | 563 | | be refunded to the plan sponsor. Except as provided for in |
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575 | 564 | | paragraph 2 of this subsection, a charge or assessment for an audit |
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576 | 565 | | shall not be based, directly or indirectly, on amounts recouped. |
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577 | 566 | | 2. This subsection does not prevent the entity c onducting the |
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578 | 567 | | audit from charging or assessing the responsible party, directly or |
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579 | 568 | | indirectly, based on amounts recouped if both of the following |
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580 | 569 | | conditions are met: |
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581 | 570 | | a. the plan sponsor and the entity conducting the audit |
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582 | 571 | | have a contract that explicitly sta tes the percentage |
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583 | 572 | | charge or assessment to the plan sponsor, and |
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584 | 573 | | b. a commission to an agent or employee of the entity |
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585 | 574 | | conducting the audit is not based, directly or |
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586 | 575 | | indirectly, on amounts recouped. |
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587 | 576 | | I. H. Unless superseded by state or federal law, auditor s shall |
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588 | 577 | | only have access to previous audit reports on a particular pharmacy |
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589 | 578 | | conducted by the auditing entity for the same pharmacy benefits |
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590 | 579 | | manager, health plan or insurer. An auditing vendor contracting |
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591 | 580 | | |
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594 | 582 | | 2 |
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595 | 583 | | 3 |
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596 | 584 | | 4 |
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597 | 585 | | 5 |
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611 | 599 | | 19 |
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614 | 602 | | 22 |
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615 | 603 | | 23 |
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616 | 604 | | 24 |
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617 | 605 | | |
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618 | 606 | | with multiple pharmacy benefits managers or health insurance plans |
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619 | 607 | | shall not use audit reports or other information gained from an |
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620 | 608 | | audit on a pharmacy to conduct another audit for a different |
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621 | 609 | | pharmacy benefits manager or health insurance plan. |
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622 | 610 | | J. Sections A through I |
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623 | 611 | | I. Paragraph 2 of subsection A of thi s section through |
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624 | 612 | | subsection D of this section, and paragraph 1 through paragraph 7 of |
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625 | 613 | | subsection F of this section shall not apply to any audit initiated |
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626 | 614 | | based on or that involves suspicion of fraud, willful |
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627 | 615 | | misrepresentation, or abuse. |
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628 | 616 | | K. J. If the Attorney General, after notice and opportunity for |
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629 | 617 | | hearing, finds that the entity conducting the audit failed to follow |
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630 | 618 | | any of the requirements pursuant to the Pharmacy Audit Integrity |
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631 | 619 | | Act, the audit shall be considered null and void. Any monies |
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632 | 620 | | recouped from a null and void audit shall be returned to the |
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633 | 621 | | affected pharmacy within fourteen (14) calendar days. Any violation |
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634 | 622 | | of this section by a pharmacy benefits manager or auditing entity |
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635 | 623 | | shall be deemed a violation of the Pharmacy Audit Integrity Act. |
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636 | 624 | | SECTION 3. AMENDATORY 59 O.S. 2021, Section 356.3, as |
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637 | 625 | | amended by Section 3, Chapter 332, O.S.L. 2024 (59 O.S. Supp. 2024, |
---|
638 | 626 | | Section 356.3), is amended to read as follows: |
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639 | 627 | | Section 356.3. A. Each entity conducting an audit shall |
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640 | 628 | | establish a written appeals process under which a pharmacy may |
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641 | 629 | | |
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644 | 631 | | 2 |
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645 | 632 | | 3 |
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646 | 633 | | 4 |
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647 | 634 | | 5 |
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648 | 635 | | 6 |
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649 | 636 | | 7 |
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650 | 637 | | 8 |
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651 | 638 | | 9 |
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652 | 639 | | 10 |
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653 | 640 | | 11 |
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654 | 641 | | 12 |
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655 | 642 | | 13 |
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656 | 643 | | 14 |
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657 | 644 | | 15 |
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658 | 645 | | 16 |
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659 | 646 | | 17 |
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660 | 647 | | 18 |
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661 | 648 | | 19 |
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662 | 649 | | 20 |
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663 | 650 | | 21 |
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664 | 651 | | 22 |
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665 | 652 | | 23 |
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666 | 653 | | 24 |
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667 | 654 | | |
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668 | 655 | | appeal an unfavorable preliminary audit report and/or final audit |
---|
669 | 656 | | report to the entity. |
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670 | 657 | | B. Following an appeal, if the entity finds that an unfavorable |
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671 | 658 | | audit report or any portion thereof is unsubstantia ted, the entity |
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672 | 659 | | shall dismiss the audit report or the unsubstantiated portion of the |
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673 | 660 | | audit report without any further action. |
---|
674 | 661 | | C. Any final audit report, following the final audit appeal |
---|
675 | 662 | | period, with a finding of fraud or willful misrepresentation shall |
---|
676 | 663 | | be referred to the district attorney having proper jurisdiction or |
---|
677 | 664 | | the Attorney General for prosecution upon completion of the appeals |
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678 | 665 | | process. If a finding of fraud or willful misrepresentation is |
---|
679 | 666 | | referred to a district attorney under this subsection, the auditing |
---|
680 | 667 | | entity shall notify the Attorney General as to whom the referral was |
---|
681 | 668 | | made and the date the referral was made. |
---|
682 | 669 | | D. For any audit initiated based on or that involves suspicion |
---|
683 | 670 | | of fraud, willful misrepresentation, or abuse, the auditing entity |
---|
684 | 671 | | shall provide, in writing, at the time of the audit, a clear and |
---|
685 | 672 | | conspicuous declaration to the pharmacy being audited that the audit |
---|
686 | 673 | | is being conducted under suspicion of fraud, willful |
---|
687 | 674 | | misrepresentation, or abuse and a statement of facts that supports |
---|
688 | 675 | | the reasonable suspicion. The entity conducting an audit based on |
---|
689 | 676 | | suspicion of fraud, willful misrepresentation, or abuse shall |
---|
690 | 677 | | provide a copy of the clear and conspicuous declaration required by |
---|
691 | 678 | | this subsection to the pharmacy’s contracting agent by certified |
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692 | 679 | | |
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695 | 681 | | 2 |
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696 | 682 | | 3 |
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697 | 683 | | 4 |
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698 | 684 | | 5 |
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699 | 685 | | 6 |
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700 | 686 | | 7 |
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701 | 687 | | 8 |
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702 | 688 | | 9 |
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703 | 689 | | 10 |
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704 | 690 | | 11 |
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705 | 691 | | 12 |
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706 | 692 | | 13 |
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707 | 693 | | 14 |
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708 | 694 | | 15 |
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709 | 695 | | 16 |
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710 | 696 | | 17 |
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711 | 697 | | 18 |
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712 | 698 | | 19 |
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713 | 699 | | 20 |
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714 | 700 | | 21 |
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715 | 701 | | 22 |
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716 | 702 | | 23 |
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717 | 703 | | 24 |
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718 | 704 | | |
---|
719 | 705 | | mail within five (5) business days of notifying the pharmacy of an |
---|
720 | 706 | | audit pursuant to this section. |
---|
721 | 707 | | E. The entity conducting an audit based on suspicion of fraud, |
---|
722 | 708 | | willful misrepresentation, or abuse shall: |
---|
723 | 709 | | 1. Deliver a preliminary findings report to the pha rmacy and |
---|
724 | 710 | | the pharmacy’s contracting agent within ninety (90) calendar days of |
---|
725 | 711 | | notification of the audit; |
---|
726 | 712 | | 2. Allow the pharmacy at least ninety (90) calendar days |
---|
727 | 713 | | following the receipt of the preliminary audit findings report in |
---|
728 | 714 | | which to produce documenta tion to address any discrepancy found |
---|
729 | 715 | | during the audit. A pharmacy may request an extension, not to |
---|
730 | 716 | | exceed an additional forty -five (45) calendar days; |
---|
731 | 717 | | 3. Deliver a final audit findings report to the pharmacy and |
---|
732 | 718 | | the pharmacy’s contracting agent signed b y the auditor within thirty |
---|
733 | 719 | | (30) calendar days after receipt of additional documentation |
---|
734 | 720 | | provided by the pharmacy; |
---|
735 | 721 | | 4. Allow the pharmacy to reverse and resubmit claims |
---|
736 | 722 | | electronically within thirty (30) calendar days of receipt of the |
---|
737 | 723 | | final audit report in lieu of the auditing entity recouping |
---|
738 | 724 | | discrepant claim amounts from the pharmacy; |
---|
739 | 725 | | 5. Not recoup any disputed funds until after the final |
---|
740 | 726 | | disposition of the audit findings, including the appeals process |
---|
741 | 727 | | pursuant to this section; |
---|
742 | 728 | | 6. Not accrue interest du ring the audit and appeal period; |
---|
743 | 729 | | |
---|
746 | 731 | | 2 |
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747 | 732 | | 3 |
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748 | 733 | | 4 |
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749 | 734 | | 5 |
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750 | 735 | | 6 |
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751 | 736 | | 7 |
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752 | 737 | | 8 |
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753 | 738 | | 9 |
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754 | 739 | | 10 |
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755 | 740 | | 11 |
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756 | 741 | | 12 |
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757 | 742 | | 13 |
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758 | 743 | | 14 |
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759 | 744 | | 15 |
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760 | 745 | | 16 |
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761 | 746 | | 17 |
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763 | 748 | | 19 |
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765 | 750 | | 21 |
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766 | 751 | | 22 |
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767 | 752 | | 23 |
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768 | 753 | | 24 |
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769 | 754 | | |
---|
770 | 755 | | 7. Ensure that each preliminary audit findings report submitted |
---|
771 | 756 | | pursuant to this section includes: |
---|
772 | 757 | | a. specific prescription numbers, fill dates, drug names, |
---|
773 | 758 | | and NDC numbers, and |
---|
774 | 759 | | b. the date of receipt of documents from th e pharmacy, |
---|
775 | 760 | | the pharmacy’s contracting agent, or any other source |
---|
776 | 761 | | associated with the audit; |
---|
777 | 762 | | 8. Ensure that each final audit findings report includes any |
---|
778 | 763 | | additional documentation that was submitted to the auditing entity; |
---|
779 | 764 | | 9. Provide the plan sponsor a co py of the final audit results |
---|
780 | 765 | | within thirty (30) calendar days of the final disposition of the |
---|
781 | 766 | | audit; and |
---|
782 | 767 | | 10. At the request of the plan sponsor, provide a copy of the |
---|
783 | 768 | | final audit report within thirty (30) calendar days of the request. |
---|
784 | 769 | | F. Any entity conducting an audit that is based on or involves |
---|
785 | 770 | | suspicion of fraud, willful misrepresentation, or abuse shall |
---|
786 | 771 | | provide to the Office of the Attorney General: |
---|
787 | 772 | | 1. Notice at least two (2) calendar days prior to beginning |
---|
788 | 773 | | performance of an audit pursuant to this section; |
---|
789 | 774 | | 2. A preliminary report within thirty (30) calendar days of |
---|
790 | 775 | | performing the audit five (5) business days of providing a copy of |
---|
791 | 776 | | the preliminary report to the pharmacy and the pharmacy’s |
---|
792 | 777 | | contracting agent pursuant to this section . The auditing entity may |
---|
793 | 778 | | |
---|
796 | 780 | | 2 |
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797 | 781 | | 3 |
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798 | 782 | | 4 |
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799 | 783 | | 5 |
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800 | 784 | | 6 |
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801 | 785 | | 7 |
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802 | 786 | | 8 |
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803 | 787 | | 9 |
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804 | 788 | | 10 |
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805 | 789 | | 11 |
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806 | 790 | | 12 |
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807 | 791 | | 13 |
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808 | 792 | | 14 |
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809 | 793 | | 15 |
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810 | 794 | | 16 |
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811 | 795 | | 17 |
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812 | 796 | | 18 |
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813 | 797 | | 19 |
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814 | 798 | | 20 |
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815 | 799 | | 21 |
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816 | 800 | | 22 |
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817 | 801 | | 23 |
---|
818 | 802 | | 24 |
---|
819 | 803 | | |
---|
820 | 804 | | request an extension from the Attorney General, not to exceed an |
---|
821 | 805 | | additional ninety (90) calendar days ; and |
---|
822 | 806 | | 3. A final report within thirty (30) ten (10) calendar days |
---|
823 | 807 | | following the closure of the final appeal period for an audit |
---|
824 | 808 | | performed pursuant to this section. |
---|
825 | 809 | | a. The final report for the Office of the Attorney |
---|
826 | 810 | | General shall include the name of each plan sponsor |
---|
827 | 811 | | whose claims were included in the audit recover, the |
---|
828 | 812 | | amount of funds recouped on behalf of the plan, the |
---|
829 | 813 | | date the plan sponsor was noti fied of the recoupment, |
---|
830 | 814 | | the date the plan sponsor was paid any recoupment, and |
---|
831 | 815 | | the name and contact information for the |
---|
832 | 816 | | representative of the plan sponsor who was notified of |
---|
833 | 817 | | the recoupment at issue in an audit pursuant to this |
---|
834 | 818 | | section. |
---|
835 | 819 | | b. The auditing entity may request an extension from the |
---|
836 | 820 | | Attorney General, not to exceed an additional ten (10) |
---|
837 | 821 | | calendar days. |
---|
838 | 822 | | F. G. The Attorney General, authorized employees, and examiners |
---|
839 | 823 | | shall have access to any pharmacy benefits manager’s files and |
---|
840 | 824 | | records that may rel ate to an any audit including, but not limited |
---|
841 | 825 | | to, an audit that is based on or involves suspicion of fraud, |
---|
842 | 826 | | willful misrepresentation, or abuse. |
---|
843 | 827 | | |
---|
846 | 829 | | 2 |
---|
847 | 830 | | 3 |
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848 | 831 | | 4 |
---|
849 | 832 | | 5 |
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850 | 833 | | 6 |
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851 | 834 | | 7 |
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852 | 835 | | 8 |
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853 | 836 | | 9 |
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854 | 837 | | 10 |
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855 | 838 | | 11 |
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856 | 839 | | 12 |
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857 | 840 | | 13 |
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858 | 841 | | 14 |
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859 | 842 | | 15 |
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860 | 843 | | 16 |
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861 | 844 | | 17 |
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862 | 845 | | 18 |
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863 | 846 | | 19 |
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864 | 847 | | 20 |
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865 | 848 | | 21 |
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866 | 849 | | 22 |
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867 | 850 | | 23 |
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868 | 851 | | 24 |
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869 | 852 | | |
---|
870 | 853 | | G. H. The Attorney General may levy a civil or administrative |
---|
871 | 854 | | fine of not less than One Hundred Dollars ($100 .00) and not greater |
---|
872 | 855 | | than Ten Thousand Dollars ($10,000.00) for each violation of this |
---|
873 | 856 | | section and assess any other penalty or remedy authorized by law. |
---|
874 | 857 | | SECTION 4. AMENDATORY 59 O.S. 2021, Section 356.4, is |
---|
875 | 858 | | amended to read as foll ows: |
---|
876 | 859 | | Section 356.4. A. For the purposes of the Pharmacy Audit |
---|
877 | 860 | | Integrity Act, “extrapolation audit” means an audit of a sample of |
---|
878 | 861 | | prescription drug benefit claims submitted by a pharmacy to the |
---|
879 | 862 | | entity conducting the audit that is then used to estimate aud it |
---|
880 | 863 | | results for a larger batch or group of claims not reviewed by the |
---|
881 | 864 | | auditor, including refills not listed in the written notification in |
---|
882 | 865 | | accordance with paragraph 2 of subsection A of Section 356.2 of this |
---|
883 | 866 | | title. |
---|
884 | 867 | | B. The entity conducting the audit shall not use the accounting |
---|
885 | 868 | | practice of extrapolation in calculating recoupments or penalties |
---|
886 | 869 | | for audits. |
---|
887 | 870 | | SECTION 5. NEW LAW A new section of law to be codified |
---|
888 | 871 | | in the Oklahoma Statutes as Section 356.6 of Title 59, unless there |
---|
889 | 872 | | is created a duplication in numbering, reads as follows: |
---|
890 | 873 | | A. Notwithstanding any other provision of law, the ability of a |
---|
891 | 874 | | pharmacy benefits manager (PBM) to initiate, continue, or conclude |
---|
892 | 875 | | an audit of a pharmacy shall be tolled for the duration of a |
---|
893 | 876 | | |
---|
896 | 878 | | 2 |
---|
897 | 879 | | 3 |
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898 | 880 | | 4 |
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899 | 881 | | 5 |
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900 | 882 | | 6 |
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901 | 883 | | 7 |
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902 | 884 | | 8 |
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903 | 885 | | 9 |
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904 | 886 | | 10 |
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905 | 887 | | 11 |
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906 | 888 | | 12 |
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907 | 889 | | 13 |
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908 | 890 | | 14 |
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909 | 891 | | 15 |
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910 | 892 | | 16 |
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911 | 893 | | 17 |
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912 | 894 | | 18 |
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913 | 895 | | 19 |
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914 | 896 | | 20 |
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915 | 897 | | 21 |
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916 | 898 | | 22 |
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917 | 899 | | 23 |
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918 | 900 | | 24 |
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919 | 901 | | |
---|
920 | 902 | | declared disaster and for an additional period of thirty (30) |
---|
921 | 903 | | calendar days following the termination of a declared disaster. |
---|
922 | 904 | | Such requirement shall apply only to the pharmacies located |
---|
923 | 905 | | within the geographical boundaries of the county or counties |
---|
924 | 906 | | affected by the declare d disaster. |
---|
925 | 907 | | B. The provisions of this section shall apply to all PBMs |
---|
926 | 908 | | operating within this state, and to all audits conducted pursuant to |
---|
927 | 909 | | contracts between PBMs and pharmacies. |
---|
928 | 910 | | C. This section shall not apply to: |
---|
929 | 911 | | 1. Audits conducted for suspected fraud ulent activity if |
---|
930 | 912 | | documented evidence of such activity exists; or |
---|
931 | 913 | | 2. Audits required to comply with federal or state law |
---|
932 | 914 | | unrelated to the contractual relationship between a PBM and a |
---|
933 | 915 | | pharmacy. |
---|
934 | 916 | | D. Nothing in this section shall be construed to prohibit a |
---|
935 | 917 | | pharmacy from voluntarily agreeing to continue or complete an audit |
---|
936 | 918 | | during the tolling period, provided such agreement is documented in |
---|
937 | 919 | | writing and signed by both parties. |
---|
938 | 920 | | E. A PBM may submit a request to the Attorney General to |
---|
939 | 921 | | continue or complete an aud it during the tolling period, which the |
---|
940 | 922 | | Attorney General may grant at his or her sole discretion. Any PBM |
---|
941 | 923 | | granted such permission by the Attorney General shall do so pursuant |
---|
942 | 924 | | to the requirements of this act. |
---|
943 | 925 | | |
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946 | 927 | | 2 |
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947 | 928 | | 3 |
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948 | 929 | | 4 |
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949 | 930 | | 5 |
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950 | 931 | | 6 |
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951 | 932 | | 7 |
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952 | 933 | | 8 |
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953 | 934 | | 9 |
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954 | 935 | | 10 |
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955 | 936 | | 11 |
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956 | 937 | | 12 |
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957 | 938 | | 13 |
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958 | 939 | | 14 |
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959 | 940 | | 15 |
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960 | 941 | | 16 |
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961 | 942 | | 17 |
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962 | 943 | | 18 |
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963 | 944 | | 19 |
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964 | 945 | | 20 |
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965 | 946 | | 21 |
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966 | 947 | | 22 |
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967 | 948 | | 23 |
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968 | 949 | | 24 |
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969 | 950 | | |
---|
970 | 951 | | SECTION 6. AMENDATORY 59 O.S. 2021, Section 357, as |
---|
971 | 952 | | amended by Section 4, Chapter 332, O.S.L. 2024 (59 O.S. Supp. 2024, |
---|
972 | 953 | | Section 357), is amended to read as follows: |
---|
973 | 954 | | Section 357. A. As used in Sections 357 through 360 of this |
---|
974 | 955 | | title and Section 9 of this act: |
---|
975 | 956 | | 1. “Covered entity” means a nonprofit hospital or medical |
---|
976 | 957 | | service organization, for -profit hospital or medical service |
---|
977 | 958 | | organization, insurer, health benefit plan, health maintenance |
---|
978 | 959 | | organization, health program administered by the state in the |
---|
979 | 960 | | capacity of providing health coverage, or an employer, labor union, |
---|
980 | 961 | | or other group of persons that provides health coverage to persons |
---|
981 | 962 | | in this state. This term does not include a health benefit plan |
---|
982 | 963 | | that provides coverage only for accidental injury, specified |
---|
983 | 964 | | disease, hospital indem nity, disability income, or other limited |
---|
984 | 965 | | benefit health insurance policies and contracts that do not include |
---|
985 | 966 | | prescription drug coverage; |
---|
986 | 967 | | 2. “Covered individual” means a member, participant, enrollee, |
---|
987 | 968 | | contract holder or policy holder or beneficiary of a c overed entity |
---|
988 | 969 | | who is provided health coverage by the covered entity. A covered |
---|
989 | 970 | | individual includes any dependent or other person provided health |
---|
990 | 971 | | coverage through a policy, contract or plan for a covered |
---|
991 | 972 | | individual; |
---|
992 | 973 | | 3. “Department” means the Insurance Dep artment; |
---|
993 | 974 | | |
---|
996 | 976 | | 2 |
---|
997 | 977 | | 3 |
---|
998 | 978 | | 4 |
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999 | 979 | | 5 |
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1000 | 980 | | 6 |
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1001 | 981 | | 7 |
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1002 | 982 | | 8 |
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1003 | 983 | | 9 |
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1004 | 984 | | 10 |
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1005 | 985 | | 11 |
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1006 | 986 | | 12 |
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1007 | 987 | | 13 |
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1008 | 988 | | 14 |
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1009 | 989 | | 15 |
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1010 | 990 | | 16 |
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1011 | 991 | | 17 |
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1012 | 992 | | 18 |
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1013 | 993 | | 19 |
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1014 | 994 | | 20 |
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1015 | 995 | | 21 |
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1016 | 996 | | 22 |
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1017 | 997 | | 23 |
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1018 | 998 | | 24 |
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1019 | 999 | | |
---|
1020 | 1000 | | 4. “Maximum allowable cost”, “MAC”, or “MAC list” means the |
---|
1021 | 1001 | | list of drug products delineating the maximum per -unit reimbursement |
---|
1022 | 1002 | | for multiple-source prescription drugs, medical product, or device; |
---|
1023 | 1003 | | 5. “Multisource drug product reimbursement” (rei mbursement) |
---|
1024 | 1004 | | means the total amount paid to a pharmacy inclusive of any reduction |
---|
1025 | 1005 | | in payment to the pharmacy, excluding prescription dispense fees; |
---|
1026 | 1006 | | 6. “Office” means the Office of the Attorney General; |
---|
1027 | 1007 | | 7. “Pharmacy benefits management” means a service pro vided to |
---|
1028 | 1008 | | covered entities to facilitate the provision of prescription drug |
---|
1029 | 1009 | | benefits to covered individuals within the state, including |
---|
1030 | 1010 | | negotiating pricing and other terms with drug manufacturers and |
---|
1031 | 1011 | | providers. Pharmacy benefits management may include any or all of |
---|
1032 | 1012 | | the following services: |
---|
1033 | 1013 | | a. claims processing, retail network management and |
---|
1034 | 1014 | | payment of claims to pharmacies for prescription drugs |
---|
1035 | 1015 | | dispensed to covered individuals, |
---|
1036 | 1016 | | b. clinical formulary development and management |
---|
1037 | 1017 | | services, or |
---|
1038 | 1018 | | c. rebate contracting and administration; |
---|
1039 | 1019 | | 8. “Pharmacy benefits manager” or “PBM” means a person, |
---|
1040 | 1020 | | business, or other entity that performs pharmacy benefits |
---|
1041 | 1021 | | management. The term shall include any business or entity licensed |
---|
1042 | 1022 | | by the Insurance Department to perform PBM service s, or a person or |
---|
1043 | 1023 | | entity acting on behalf of a PBM in a contractual or employment |
---|
1044 | 1024 | | |
---|
1047 | 1026 | | 2 |
---|
1048 | 1027 | | 3 |
---|
1049 | 1028 | | 4 |
---|
1050 | 1029 | | 5 |
---|
1051 | 1030 | | 6 |
---|
1052 | 1031 | | 7 |
---|
1053 | 1032 | | 8 |
---|
1054 | 1033 | | 9 |
---|
1055 | 1034 | | 10 |
---|
1056 | 1035 | | 11 |
---|
1057 | 1036 | | 12 |
---|
1058 | 1037 | | 13 |
---|
1059 | 1038 | | 14 |
---|
1060 | 1039 | | 15 |
---|
1061 | 1040 | | 16 |
---|
1062 | 1041 | | 17 |
---|
1063 | 1042 | | 18 |
---|
1064 | 1043 | | 19 |
---|
1065 | 1044 | | 20 |
---|
1066 | 1045 | | 21 |
---|
1067 | 1046 | | 22 |
---|
1068 | 1047 | | 23 |
---|
1069 | 1048 | | 24 |
---|
1070 | 1049 | | |
---|
1071 | 1050 | | relationship in the performance of pharmacy benefits management for |
---|
1072 | 1051 | | a managed care company, nonprofit hospital, medical service |
---|
1073 | 1052 | | organization, insurance company, third -party payor, or a health |
---|
1074 | 1053 | | program administered by an agency or department of this state; |
---|
1075 | 1054 | | 9. “Plan sponsor” means the employers, insurance companies, |
---|
1076 | 1055 | | unions and health maintenance organizations or any other entity |
---|
1077 | 1056 | | responsible for establishing, maintaining, or admi nistering a health |
---|
1078 | 1057 | | benefit plan on behalf of covered individuals; and |
---|
1079 | 1058 | | 10. “Provider” means a pharmacy licensed by the State Board of |
---|
1080 | 1059 | | Pharmacy, or an agent or representative of a pharmacy, including, |
---|
1081 | 1060 | | but not limited to, the pharmacy’s contracting agent, wh ich |
---|
1082 | 1061 | | dispenses prescription drugs or devices to covered individuals. |
---|
1083 | 1062 | | B. Nothing in the definition of pharmacy benefits management or |
---|
1084 | 1063 | | pharmacy benefits manager in the Patient’s Right to Pharmacy Choice |
---|
1085 | 1064 | | Act, Pharmacy Audit Integrity Act, or Sections 357 through 360 of |
---|
1086 | 1065 | | this title, or Section 9 of this act shall deem an employer a |
---|
1087 | 1066 | | “pharmacy benefits manager” pharmacy benefits manager of its own |
---|
1088 | 1067 | | self-funded health benefit plan, except, to the extent permitted by |
---|
1089 | 1068 | | applicable law, where the employer, without the ut ilization of a |
---|
1090 | 1069 | | third party and unrelated to the employer’s own pharmacy: |
---|
1091 | 1070 | | a. negotiates |
---|
1092 | 1071 | | 1. Negotiates directly with drug manufacturers ,; |
---|
1093 | 1072 | | b. processes |
---|
1094 | 1073 | | 2. Processes claims on behalf of its members ,; or |
---|
1095 | 1074 | | |
---|
1098 | 1076 | | 2 |
---|
1099 | 1077 | | 3 |
---|
1100 | 1078 | | 4 |
---|
1101 | 1079 | | 5 |
---|
1102 | 1080 | | 6 |
---|
1103 | 1081 | | 7 |
---|
1104 | 1082 | | 8 |
---|
1105 | 1083 | | 9 |
---|
1106 | 1084 | | 10 |
---|
1107 | 1085 | | 11 |
---|
1108 | 1086 | | 12 |
---|
1109 | 1087 | | 13 |
---|
1110 | 1088 | | 14 |
---|
1111 | 1089 | | 15 |
---|
1112 | 1090 | | 16 |
---|
1113 | 1091 | | 17 |
---|
1114 | 1092 | | 18 |
---|
1115 | 1093 | | 19 |
---|
1116 | 1094 | | 20 |
---|
1117 | 1095 | | 21 |
---|
1118 | 1096 | | 22 |
---|
1119 | 1097 | | 23 |
---|
1120 | 1098 | | 24 |
---|
1121 | 1099 | | |
---|
1122 | 1100 | | c. manages |
---|
1123 | 1101 | | 3. Manages its own retail network of pharma cies. |
---|
1124 | 1102 | | SECTION 7. AMENDATORY 59 O.S. 2021, Section 358, as |
---|
1125 | 1103 | | amended by Section 5, Chapter 332, O.S.L. 2024 (59 O.S. Supp. 2024, |
---|
1126 | 1104 | | Section 358), is amended to read as follows: |
---|
1127 | 1105 | | Section 358. A. In order to provide pharmacy benefits |
---|
1128 | 1106 | | management or any of the services included under the definition of |
---|
1129 | 1107 | | pharmacy benefits management in this state, a pharmacy benefits |
---|
1130 | 1108 | | manager or any entity acting as one in a contractual or employment |
---|
1131 | 1109 | | relationship for a covered entity shall first obtain a licens e from |
---|
1132 | 1110 | | the Insurance Department, and the Department may charge a fee for |
---|
1133 | 1111 | | such licensure. |
---|
1134 | 1112 | | B. The Department shall establish, by regulation, licensure |
---|
1135 | 1113 | | procedures, required disclosures for pharmacy benefits managers |
---|
1136 | 1114 | | (PBMs) and other rules as may be necessary for carrying out and |
---|
1137 | 1115 | | enforcing the provisions of this title. The licensure procedures |
---|
1138 | 1116 | | shall, at a minimum, include the completion of an application form |
---|
1139 | 1117 | | that shall include the name and address of an agent for service of |
---|
1140 | 1118 | | process, the payment of a requisit e fee, and evidence of the |
---|
1141 | 1119 | | procurement of a surety bond. |
---|
1142 | 1120 | | C. The Department or the Office of the Attorney General may |
---|
1143 | 1121 | | subpoena witnesses and information. Its compliance officers may |
---|
1144 | 1122 | | take and copy records for investigative use and prosecutions. |
---|
1145 | 1123 | | Nothing in this subsection shall limit the Office of the Attorney |
---|
1146 | 1124 | | |
---|
1149 | 1126 | | 2 |
---|
1150 | 1127 | | 3 |
---|
1151 | 1128 | | 4 |
---|
1152 | 1129 | | 5 |
---|
1153 | 1130 | | 6 |
---|
1154 | 1131 | | 7 |
---|
1155 | 1132 | | 8 |
---|
1156 | 1133 | | 9 |
---|
1157 | 1134 | | 10 |
---|
1158 | 1135 | | 11 |
---|
1159 | 1136 | | 12 |
---|
1160 | 1137 | | 13 |
---|
1161 | 1138 | | 14 |
---|
1162 | 1139 | | 15 |
---|
1163 | 1140 | | 16 |
---|
1164 | 1141 | | 17 |
---|
1165 | 1142 | | 18 |
---|
1166 | 1143 | | 19 |
---|
1167 | 1144 | | 20 |
---|
1168 | 1145 | | 21 |
---|
1169 | 1146 | | 22 |
---|
1170 | 1147 | | 23 |
---|
1171 | 1148 | | 24 |
---|
1172 | 1149 | | |
---|
1173 | 1150 | | General from using its investigative demand authority to investigate |
---|
1174 | 1151 | | and prosecute violations of the law. |
---|
1175 | 1152 | | D. The Department may suspend, revoke or refuse to issue or |
---|
1176 | 1153 | | renew a license for noncompliance with any of the provisions hereby |
---|
1177 | 1154 | | established or with the rules promulgated by the Department; for |
---|
1178 | 1155 | | conduct likely to mislead, deceive or defraud the public or the |
---|
1179 | 1156 | | Department; for unfair or deceptive business practices or for |
---|
1180 | 1157 | | nonpayment of an application o r renewal fee or fine. The Department |
---|
1181 | 1158 | | may also levy administrative fines for each count of which a PBM has |
---|
1182 | 1159 | | been convicted in a Department hearing. |
---|
1183 | 1160 | | E. 1. The Office of the Attorney General , after notice and |
---|
1184 | 1161 | | opportunity for hearing, may instruct the Insur ance Commissioner |
---|
1185 | 1162 | | that the PBM’s license be censured, suspended, or revoked for |
---|
1186 | 1163 | | conduct likely to mislead, deceive, or defraud the public or the |
---|
1187 | 1164 | | State of Oklahoma; or for unfair or deceptive business practices, or |
---|
1188 | 1165 | | for any violation of the Patient’s Right t o Pharmacy Choice Act, the |
---|
1189 | 1166 | | Pharmacy Audit Integrity Act, or Sections 357 through 360 of this |
---|
1190 | 1167 | | title, or Section 9 of this act. The Office of the Attorney General |
---|
1191 | 1168 | | may also levy administrative fines for each count of which a PBM has |
---|
1192 | 1169 | | been convicted following a hearing before the Attorney General. If |
---|
1193 | 1170 | | the Attorney General makes such instruction, the Commissioner shall |
---|
1194 | 1171 | | enforce the instructed action within thirty (30) calendar days. |
---|
1195 | 1172 | | 2. In addition to or in lieu of any censure, suspension, or |
---|
1196 | 1173 | | revocation of a lice nse by the Commissioner, the Attorney General |
---|
1197 | 1174 | | |
---|
1200 | 1176 | | 2 |
---|
1201 | 1177 | | 3 |
---|
1202 | 1178 | | 4 |
---|
1203 | 1179 | | 5 |
---|
1204 | 1180 | | 6 |
---|
1205 | 1181 | | 7 |
---|
1206 | 1182 | | 8 |
---|
1207 | 1183 | | 9 |
---|
1208 | 1184 | | 10 |
---|
1209 | 1185 | | 11 |
---|
1210 | 1186 | | 12 |
---|
1211 | 1187 | | 13 |
---|
1212 | 1188 | | 14 |
---|
1213 | 1189 | | 15 |
---|
1214 | 1190 | | 16 |
---|
1215 | 1191 | | 17 |
---|
1216 | 1192 | | 18 |
---|
1217 | 1193 | | 19 |
---|
1218 | 1194 | | 20 |
---|
1219 | 1195 | | 21 |
---|
1220 | 1196 | | 22 |
---|
1221 | 1197 | | 23 |
---|
1222 | 1198 | | 24 |
---|
1223 | 1199 | | |
---|
1224 | 1200 | | may levy a civil or administrative fine of not less than One Hundred |
---|
1225 | 1201 | | Dollars ($100.00) and not greater than Ten Thousand Dollars |
---|
1226 | 1202 | | ($10,000.00) for each violation of this subsection and/or assess any |
---|
1227 | 1203 | | other penalty or remedy authorized by this section. For purposes of |
---|
1228 | 1204 | | this section, each day a PBM fails to comply with an investigation |
---|
1229 | 1205 | | or inquiry may be considered a separate violation. |
---|
1230 | 1206 | | F. The Attorney General may promulgate rules to implement the |
---|
1231 | 1207 | | provisions of Sections 357 through 360 of this title and Section 9 |
---|
1232 | 1208 | | of this act. |
---|
1233 | 1209 | | SECTION 8. AMENDATORY 59 O.S. 2021, Section 360, as |
---|
1234 | 1210 | | amended by Section 6, Chapter 332, O.S.L. 2024 (59 O.S. Supp. 2024, |
---|
1235 | 1211 | | Section 360), is amended to read as follows: |
---|
1236 | 1212 | | Section 360. A. The pharmacy benefits manager shall, with |
---|
1237 | 1213 | | respect to contracts between a pharmacy benefits manager and a |
---|
1238 | 1214 | | provider, including a pharmacy service administrative organization: |
---|
1239 | 1215 | | l. Include in such contracts the specific sources utilized to |
---|
1240 | 1216 | | determine the maximum allowable cost (MAC) pricing of the pharmacy, |
---|
1241 | 1217 | | update MAC pricing at least every seven (7) calendar days, and |
---|
1242 | 1218 | | establish a process for providers to readily access the MAC list |
---|
1243 | 1219 | | specific to that provider; |
---|
1244 | 1220 | | 2. In order to place a drug on the MA C list, ensure that the |
---|
1245 | 1221 | | drug is listed as “A” or “B” rated in the most recent version of the |
---|
1246 | 1222 | | FDA’s United States Food and Drug Administration (FDA) Approved Drug |
---|
1247 | 1223 | | Products with Therapeutic Equivalence Evaluations, also known as the |
---|
1248 | 1224 | | |
---|
1251 | 1226 | | 2 |
---|
1252 | 1227 | | 3 |
---|
1253 | 1228 | | 4 |
---|
1254 | 1229 | | 5 |
---|
1255 | 1230 | | 6 |
---|
1256 | 1231 | | 7 |
---|
1257 | 1232 | | 8 |
---|
1258 | 1233 | | 9 |
---|
1259 | 1234 | | 10 |
---|
1260 | 1235 | | 11 |
---|
1261 | 1236 | | 12 |
---|
1262 | 1237 | | 13 |
---|
1263 | 1238 | | 14 |
---|
1264 | 1239 | | 15 |
---|
1265 | 1240 | | 16 |
---|
1266 | 1241 | | 17 |
---|
1267 | 1242 | | 18 |
---|
1268 | 1243 | | 19 |
---|
1269 | 1244 | | 20 |
---|
1270 | 1245 | | 21 |
---|
1271 | 1246 | | 22 |
---|
1272 | 1247 | | 23 |
---|
1273 | 1248 | | 24 |
---|
1274 | 1249 | | |
---|
1275 | 1250 | | Orange Book, and the drug is generally available for purchase by |
---|
1276 | 1251 | | pharmacies in the state from national or regional wholesalers and is |
---|
1277 | 1252 | | not obsolete; |
---|
1278 | 1253 | | 3. Ensure dispensing fees are not included in the calculation |
---|
1279 | 1254 | | of MAC price reimbursement to pharmacy providers; |
---|
1280 | 1255 | | 4. Provide a reason able administration appeals procedure to |
---|
1281 | 1256 | | allow a provider, a provider’s representative and a pharmacy service |
---|
1282 | 1257 | | administrative organization to contest reimbursement amounts within |
---|
1283 | 1258 | | fourteen (14) calendar days of the final adjusted payment date. The |
---|
1284 | 1259 | | pharmacy benefits manager shall not prevent the pharmacy or the |
---|
1285 | 1260 | | pharmacy service administrative organization from filing |
---|
1286 | 1261 | | reimbursement appeals in an electronic batch format. The pharmacy |
---|
1287 | 1262 | | benefits manager must respond to a provider, a provider’s |
---|
1288 | 1263 | | representative and a pharmacy service administrative organization |
---|
1289 | 1264 | | who have contested a reimbursement amount through this procedure |
---|
1290 | 1265 | | within ten (10) calendar days. The pharmacy benefits manager must |
---|
1291 | 1266 | | respond in an electronic batch format to reimbursement appeals filed |
---|
1292 | 1267 | | in an electronic batch format. The pharmacy benefits manager shall |
---|
1293 | 1268 | | not require a pharmacy or pharmacy services administrative |
---|
1294 | 1269 | | organization to log into a system to upload individual claim appeals |
---|
1295 | 1270 | | or to download individual appeal responses. If a price update is |
---|
1296 | 1271 | | warranted, the pharmacy benefits manager shall make the change in |
---|
1297 | 1272 | | the reimbursement amount, permit the dispensing pharmacy to reverse |
---|
1298 | 1273 | | |
---|
1301 | 1275 | | 2 |
---|
1302 | 1276 | | 3 |
---|
1303 | 1277 | | 4 |
---|
1304 | 1278 | | 5 |
---|
1305 | 1279 | | 6 |
---|
1306 | 1280 | | 7 |
---|
1307 | 1281 | | 8 |
---|
1308 | 1282 | | 9 |
---|
1309 | 1283 | | 10 |
---|
1310 | 1284 | | 11 |
---|
1311 | 1285 | | 12 |
---|
1312 | 1286 | | 13 |
---|
1313 | 1287 | | 14 |
---|
1314 | 1288 | | 15 |
---|
1315 | 1289 | | 16 |
---|
1316 | 1290 | | 17 |
---|
1317 | 1291 | | 18 |
---|
1318 | 1292 | | 19 |
---|
1319 | 1293 | | 20 |
---|
1320 | 1294 | | 21 |
---|
1321 | 1295 | | 22 |
---|
1322 | 1296 | | 23 |
---|
1323 | 1297 | | 24 |
---|
1324 | 1298 | | |
---|
1325 | 1299 | | and rebill the claim in question, and make the reimbursement amount |
---|
1326 | 1300 | | change retroactive and effective for all contracted prov iders; and |
---|
1327 | 1301 | | 5. If a below-cost reimbursement appeal is denied, the PBM |
---|
1328 | 1302 | | shall provide the reason for the denial, including the National Drug |
---|
1329 | 1303 | | Code (NDC) number from, and the name of, the specific national or |
---|
1330 | 1304 | | regional wholesalers doing business in this state where the drug is |
---|
1331 | 1305 | | currently in stock and available for purchase by the dispensing |
---|
1332 | 1306 | | pharmacy at a price below the PBM’s reimbursement price. The PBM |
---|
1333 | 1307 | | shall include documented proof from the specific national or |
---|
1334 | 1308 | | regional wholesalers doing business in this sta te showing that the |
---|
1335 | 1309 | | drug is currently in stock and available for purchase by the |
---|
1336 | 1310 | | dispensing pharmacy at a price below the PBM’s reimbursement price. |
---|
1337 | 1311 | | If the NDC number provided by the pharmacy benefits manager is not |
---|
1338 | 1312 | | available below the acquisition cost ob tained from the |
---|
1339 | 1313 | | pharmaceutical wholesaler from whom the dispensing pharmacy |
---|
1340 | 1314 | | purchases the majority of the prescription drugs that are dispensed, |
---|
1341 | 1315 | | the pharmacy benefits manager shall immediately adjust the |
---|
1342 | 1316 | | reimbursement amount, permit the dispensing pharmacy to reverse and |
---|
1343 | 1317 | | rebill the claim in question, and make the reimbursement amount |
---|
1344 | 1318 | | adjustment retroactive and effective for all contracted providers ; |
---|
1345 | 1319 | | 6. Any appeal that results in an increase in the reimbursement |
---|
1346 | 1320 | | from the PBM that continues to be below the p harmacy’s acquisition |
---|
1347 | 1321 | | cost shall be considered a denial under this section. Any denial of |
---|
1348 | 1322 | | |
---|
1351 | 1324 | | 2 |
---|
1352 | 1325 | | 3 |
---|
1353 | 1326 | | 4 |
---|
1354 | 1327 | | 5 |
---|
1355 | 1328 | | 6 |
---|
1356 | 1329 | | 7 |
---|
1357 | 1330 | | 8 |
---|
1358 | 1331 | | 9 |
---|
1359 | 1332 | | 10 |
---|
1360 | 1333 | | 11 |
---|
1361 | 1334 | | 12 |
---|
1362 | 1335 | | 13 |
---|
1363 | 1336 | | 14 |
---|
1364 | 1337 | | 15 |
---|
1365 | 1338 | | 16 |
---|
1366 | 1339 | | 17 |
---|
1367 | 1340 | | 18 |
---|
1368 | 1341 | | 19 |
---|
1369 | 1342 | | 20 |
---|
1370 | 1343 | | 21 |
---|
1371 | 1344 | | 22 |
---|
1372 | 1345 | | 23 |
---|
1373 | 1346 | | 24 |
---|
1374 | 1347 | | |
---|
1375 | 1348 | | an appeal shall follow the requirements of paragraph 5 of this |
---|
1376 | 1349 | | subsection; and |
---|
1377 | 1350 | | 7. The PBM shall not require a pharmacy to collect additional |
---|
1378 | 1351 | | monies following a succ essful below-cost reimbursement appeal from |
---|
1379 | 1352 | | any person or entity other than the PBM who adjudicated the drug |
---|
1380 | 1353 | | claim, including the patient or plan sponsor . |
---|
1381 | 1354 | | B. The reimbursement appeal requirements in this section shall |
---|
1382 | 1355 | | apply to all drugs, medical products, or devices reimbursed |
---|
1383 | 1356 | | according to any payment methodology, including, but not limited to: |
---|
1384 | 1357 | | 1. Average acquisition cost, including the National Average |
---|
1385 | 1358 | | Drug Acquisition Cost; |
---|
1386 | 1359 | | 2. Average manufacturer price; |
---|
1387 | 1360 | | 3. Average wholesale price; |
---|
1388 | 1361 | | 4. Brand effective rate or generic effective rate; |
---|
1389 | 1362 | | 5. Discount indexing; |
---|
1390 | 1363 | | 6. Federal upper limits; |
---|
1391 | 1364 | | 7. Wholesale acquisition cost; and |
---|
1392 | 1365 | | 8. Any other term that a pharmacy benefits manager or an |
---|
1393 | 1366 | | insurer of a health benefit plan may use to establish reimbursement |
---|
1394 | 1367 | | rates to a pharmacist or pharmacy for pharmacist services. |
---|
1395 | 1368 | | C. The pharmacy benefits manager shall not place a drug on a |
---|
1396 | 1369 | | MAC list, unless there are at least two therapeutically equivalent, |
---|
1397 | 1370 | | multiple-source drugs, generally available for purchase by |
---|
1398 | 1371 | | dispensing retail ph armacies from national or regional wholesalers. |
---|
1399 | 1372 | | |
---|
1402 | 1374 | | 2 |
---|
1403 | 1375 | | 3 |
---|
1404 | 1376 | | 4 |
---|
1405 | 1377 | | 5 |
---|
1406 | 1378 | | 6 |
---|
1407 | 1379 | | 7 |
---|
1408 | 1380 | | 8 |
---|
1409 | 1381 | | 9 |
---|
1410 | 1382 | | 10 |
---|
1411 | 1383 | | 11 |
---|
1412 | 1384 | | 12 |
---|
1413 | 1385 | | 13 |
---|
1414 | 1386 | | 14 |
---|
1415 | 1387 | | 15 |
---|
1416 | 1388 | | 16 |
---|
1417 | 1389 | | 17 |
---|
1418 | 1390 | | 18 |
---|
1419 | 1391 | | 19 |
---|
1420 | 1392 | | 20 |
---|
1421 | 1393 | | 21 |
---|
1422 | 1394 | | 22 |
---|
1423 | 1395 | | 23 |
---|
1424 | 1396 | | 24 |
---|
1425 | 1397 | | |
---|
1426 | 1398 | | D. In the event that a drug is placed on the FDA Drug Shortages |
---|
1427 | 1399 | | Database, pharmacy benefits managers shall reimburse claims to |
---|
1428 | 1400 | | pharmacies at no less than the wholesale acquisition cost for the |
---|
1429 | 1401 | | specific NDC number being dispensed. |
---|
1430 | 1402 | | E. The pharmacy benefits manager shall not require |
---|
1431 | 1403 | | accreditation or licensing of providers, or any entity licensed or |
---|
1432 | 1404 | | regulated by the State Board of Pharmacy, other than by the State |
---|
1433 | 1405 | | Board of Pharmacy or federal government entity a s a condition for |
---|
1434 | 1406 | | participation as a network provider. |
---|
1435 | 1407 | | F. A pharmacy or pharmacist may decline to provide the |
---|
1436 | 1408 | | pharmacist clinical or dispensing services to a patient or pharmacy |
---|
1437 | 1409 | | benefits manager if the pharmacy or pharmacist is to be paid less |
---|
1438 | 1410 | | than the pharmacy’s cost for providing the pharmacist clinical or |
---|
1439 | 1411 | | dispensing services. |
---|
1440 | 1412 | | G. The pharmacy benefits manager shall provide a dedicated |
---|
1441 | 1413 | | telephone number, email address and names of the personnel with |
---|
1442 | 1414 | | decision-making authority regarding MAC appeals and pric ing. |
---|
1443 | 1415 | | SECTION 9. NEW LAW A new section of law to be codified |
---|
1444 | 1416 | | in the Oklahoma Statutes as Section 360.1 of Title 59, unless there |
---|
1445 | 1417 | | is created a duplication in numbering, reads as follows: |
---|
1446 | 1418 | | A. If a disaster declaration is issued for a c ounty in this |
---|
1447 | 1419 | | state, the time period for a provider, a provider ’s representative, |
---|
1448 | 1420 | | or a pharmacy service administrative organization to file a below - |
---|
1449 | 1421 | | cost reimbursement appeal pursuant to Section 360 of Title 59 of the |
---|
1450 | 1422 | | |
---|
1453 | 1424 | | 2 |
---|
1454 | 1425 | | 3 |
---|
1455 | 1426 | | 4 |
---|
1456 | 1427 | | 5 |
---|
1457 | 1428 | | 6 |
---|
1458 | 1429 | | 7 |
---|
1459 | 1430 | | 8 |
---|
1460 | 1431 | | 9 |
---|
1461 | 1432 | | 10 |
---|
1462 | 1433 | | 11 |
---|
1463 | 1434 | | 12 |
---|
1464 | 1435 | | 13 |
---|
1465 | 1436 | | 14 |
---|
1466 | 1437 | | 15 |
---|
1467 | 1438 | | 16 |
---|
1468 | 1439 | | 17 |
---|
1469 | 1440 | | 18 |
---|
1470 | 1441 | | 19 |
---|
1471 | 1442 | | 20 |
---|
1472 | 1443 | | 21 |
---|
1473 | 1444 | | 22 |
---|
1474 | 1445 | | 23 |
---|
1475 | 1446 | | 24 |
---|
1476 | 1447 | | |
---|
1477 | 1448 | | Oklahoma Statutes shall be tolled for t he duration of the disaster |
---|
1478 | 1449 | | declaration. |
---|
1479 | 1450 | | B. Upon the expiration of the disaster declaration, the tolling |
---|
1480 | 1451 | | of the filing period for below -cost reimbursement appeals shall |
---|
1481 | 1452 | | continue for an additional thirty (30) calendar days. Afterward, |
---|
1482 | 1453 | | the time period for filing a below-cost reimbursement appeal, as |
---|
1483 | 1454 | | otherwise provided under state law, shall resume. |
---|
1484 | 1455 | | C. The tolling provisions of this section shall apply only to |
---|
1485 | 1456 | | continuing counties included in the declared disaster area and to |
---|
1486 | 1457 | | below-cost reimbursement appeals arising from claims impacted during |
---|
1487 | 1458 | | the time period of the declared disaster. |
---|
1488 | 1459 | | D. A pharmacy benefits manager (PBM) shall not deny a below - |
---|
1489 | 1460 | | cost reimbursement appeal on timeliness if such appeal is filed |
---|
1490 | 1461 | | during the tolled period provided in this section. |
---|
1491 | 1462 | | E. The Attorney General may promulgate rules to implement the |
---|
1492 | 1463 | | provisions of this act. |
---|
1493 | 1464 | | SECTION 10. It being immediately necessary for the preservation |
---|
1494 | 1465 | | of the public peace, health or safety, an emergency is hereby |
---|
1495 | 1466 | | declared to exist, by reason whereof this act shall take effect and |
---|
1496 | 1467 | | be in full force from and after its passage and approval. |
---|
1497 | 1468 | | |
---|