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49 | 47 | | BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA: |
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50 | 48 | | SECTION 1. AMENDATORY 59 O.S. 2021, Section 357, |
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51 | 49 | | is amended to read as follows: |
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52 | 50 | | Section 357. As used in this act: |
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53 | 51 | | 1. "Covered entity" mean s: |
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54 | 52 | | a. a nonprofit hospital or medical service organization, |
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55 | 53 | | insurer, health coverage plan or health maintenance |
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56 | 54 | | organization;, |
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57 | 55 | | b. a health program administered by the state in the |
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58 | 56 | | capacity of provider of health coverage;, or |
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59 | 57 | | c. an employer, labor union, o r other entity organized in |
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60 | 58 | | the state that provi des health coverage to covered |
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61 | 59 | | individuals who are employed or reside in the state. |
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89 | 86 | | This term does not include a health plan that provides coverage onl y |
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90 | 87 | | for accidental injury, specified disease, hospital in demnity, |
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91 | 88 | | disability income, or other limited ben efit health insurance |
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92 | 89 | | policies and contracts that do not include prescription drug |
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93 | 90 | | coverage; |
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94 | 91 | | 2. "Covered individual" means a member, participant, enroll ee, |
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95 | 92 | | contract holder or policy holder or beneficiary of a covered entity |
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96 | 93 | | who is provided health coverage by the covered entity. A covered |
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97 | 94 | | individual includes any dependent or other person provided health |
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98 | 95 | | coverage through a policy, contract or plan for a co vered |
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99 | 96 | | individual; |
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100 | 97 | | 3. "Department" means the Oklahoma I nsurance Department; |
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101 | 98 | | 4. "Maximum allowable cost " or "MAC" means the list of drug |
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102 | 99 | | products delineating the maximum per -unit reimbursement for |
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103 | 100 | | multiple-source prescription drugs, medical product or devi ce; |
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104 | 101 | | 5. "Multisource drug product reimbursement" (reimb ursement) |
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105 | 102 | | means the total amount paid to a pharm acy inclusive of any reduction |
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106 | 103 | | in payment to the pharmacy, excluding prescription dispense fees; |
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107 | 104 | | 6. "Pharmacy benefits management" means a service provi ded to |
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108 | 105 | | covered entities to facilitate the provision of prescription drug |
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109 | 106 | | benefits to covered individual s within the state, including |
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110 | 107 | | negotiating pricing and other terms with drug manufacturers and |
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111 | 108 | | providers. Pharmacy benefits management may include any or all of |
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112 | 109 | | the following services: |
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139 | 135 | | |
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140 | 136 | | a. claims processing, r etail network management and |
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141 | 137 | | payment of claims to pharmacies for prescription drugs |
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142 | 138 | | dispensed to covered individuals, |
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143 | 139 | | b. clinical formulary development and management |
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144 | 140 | | services, |
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145 | 141 | | c. rebate contracting an d administration, |
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146 | 142 | | d. certain patient compliance, therap eutic intervention |
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147 | 143 | | and generic substitution prog rams, or |
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148 | 144 | | e. disease management programs; |
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149 | 145 | | 7. "Pharmacy benefits manager" or "PBM" means a person, |
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150 | 146 | | business or other entity that performs pharmacy benefit s management. |
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151 | 147 | | The term includes a person or entity act ing for a PBM in a |
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152 | 148 | | contractual or employment rel ationship in the performance of |
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153 | 149 | | pharmacy benefits management for a managed care company, nonprofit |
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154 | 150 | | hospital, medical service organization, insurance comp any, third- |
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155 | 151 | | party payor, or a health program administere d by an agency of this |
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156 | 152 | | state; |
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157 | 153 | | 8. "Plan sponsor" means the employers, insurance companies, |
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158 | 154 | | unions and health maintenance organizations or any other entity |
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159 | 155 | | responsible for establishing, maintaining, or administering a health |
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160 | 156 | | benefit plan on behalf of covere d individuals; and |
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161 | 157 | | 9. "Provider" means a pharma cy licensed by the State Board of |
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162 | 158 | | Pharmacy, or an agent or representative of a pharmacy, including, |
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189 | 184 | | |
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190 | 185 | | but not limited to, the pharmacy's contracting agent, which |
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191 | 186 | | dispenses prescription drugs or devices to cover ed individuals; and |
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192 | 187 | | 10. "Retail pharmacy" or "pharmacy" means a pharmacy, as |
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193 | 188 | | defined in Section 353.1 of this title. |
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194 | 189 | | SECTION 2. AMENDATORY 59 O.S. 2021, Section 358, is |
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195 | 190 | | amended to read as follows: |
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196 | 191 | | Section 358. A. In order to provide phar macy benefits |
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197 | 192 | | management or any of the services included under the definition of |
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198 | 193 | | pharmacy benefits management in this state, a phar macy benefits |
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199 | 194 | | manager or any entity acting as one in a contrac tual or employment |
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200 | 195 | | relationship for a covered entity shall firs t obtain a license from |
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201 | 196 | | the Oklahoma Insurance Department, and the Department may charge a |
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202 | 197 | | fee for such licensure. |
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203 | 198 | | B. The Department shall establish, by regulation, licensure |
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204 | 199 | | procedures, required disclosures for pharmacy benefits managers |
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205 | 200 | | (PBMs) and other rules as may be necessary for carryin g out and |
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206 | 201 | | enforcing the provisions of this act. The licensure procedures |
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207 | 202 | | shall, at a minimum, include the completion of an application form |
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208 | 203 | | that shall include the name and address of an agent for service of |
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209 | 204 | | process, the payment of a requisite fee, and evi dence of the |
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210 | 205 | | procurement of a surety bond. |
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211 | 206 | | C. The Department may subpoena witnesses and info rmation. Its |
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212 | 207 | | compliance officers may take and copy records fo r investigative use |
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213 | 208 | | and prosecutions. Nothing in this subsecti on shall limit the Office |
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241 | 235 | | of the Attorney General from using its investigative demand |
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242 | 236 | | authority to investigate and prosecute violat ions of the law. |
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243 | 237 | | D. The Department may issue a cease and desist order, place on |
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244 | 238 | | probation, suspend, revoke or refuse to issu e or renew a license for |
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245 | 239 | | noncompliance with any of the provisions hereby established or with |
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246 | 240 | | the rules promulgated by the D epartment; for conduct likely to |
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247 | 241 | | mislead, deceive or defraud th e public or the Department; for unfair |
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248 | 242 | | or deceptive business practices or for nonpayment of a renewal fee |
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249 | 243 | | or fine. The Department may also issue or order a reprimand, |
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250 | 244 | | require restitution, and levy administrative fines not to exceed Ten |
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251 | 245 | | Thousand Dollars ($10,000.00) for each count of which a PBM has been |
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252 | 246 | | convicted in a Depar tment hearing any pharmacy benefits ma nager has |
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253 | 247 | | violated any of the provisions hereby established or with the rules |
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254 | 248 | | promulgated by the Department . |
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255 | 249 | | SECTION 3. AMENDATORY 59 O.S. 2021, Section 360, is |
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256 | 250 | | amended to read as follows: |
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257 | 251 | | Section 360. A. The pharmacy benefits m anager shall, with |
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258 | 252 | | respect to contracts between a pharmacy be nefits manager and a |
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259 | 253 | | provider, including a pharmacy service administrative organization : |
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260 | 254 | | 1. Include in such contracts the specific sources utilized to |
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261 | 255 | | determine the maximum allowable cost (MAC) pricing of the pharmacy, |
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262 | 256 | | update MAC pricing at least every se ven (7) calendar days, and |
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263 | 257 | | establish a process for providers to readily access the MAC list |
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264 | 258 | | specific to that provider; |
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292 | 285 | | 2. In order to place a drug on the MAC list, ensure that the |
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293 | 286 | | drug is listed as "A" or "B" rated in the most recent version of the |
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294 | 287 | | FDA's Approved Drug Products with Therapeutic Equivalence |
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295 | 288 | | Evaluations, also known as the Orange Book , and the drug is |
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296 | 289 | | generally available for pur chase by pharmacies in the state from |
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297 | 290 | | national or regional wholesalers and is not obsolete; |
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298 | 291 | | 3. Ensure dispensing fee s are not included in the calculation |
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299 | 292 | | of MAC price reimbursement to pharmacy providers; |
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300 | 293 | | 4. Provide a reasonable administration appeal s procedure to |
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301 | 294 | | allow a provider, a provider's representative and a pharmacy service |
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302 | 295 | | administrative organization to contest reimbursement amounts within |
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303 | 296 | | fourteen (14) business days of the final adjusted payment date . The |
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304 | 297 | | pharmacy benefits manager shall not pr event the pharmacy o r the |
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305 | 298 | | pharmacy service administrative organization from filing |
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306 | 299 | | reimbursement appeals in an electron ic batch format. The pharmacy |
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307 | 300 | | benefits manager must respond to a provider , a provider's |
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308 | 301 | | representative and a pharmacy service administra tive organization |
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309 | 302 | | who have contested a reimbursement amoun t through this procedure |
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310 | 303 | | within ten (10) business days . The pharmacy benefits manager must |
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311 | 304 | | respond in an electronic batch format to reimbursement appeals filed |
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312 | 305 | | in an electronic batch format . The pharmacy benefits man ager shall |
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313 | 306 | | not require a pharmacy or p harmacy services administrative |
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314 | 307 | | organization to log into a sy stem to upload individual claim appeals |
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315 | 308 | | or to download individual appeal responses . If a price update is |
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343 | 335 | | warranted, the pharmacy benefit s manager shall make the change in |
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344 | 336 | | the reimbursement amoun t, permit the dispensing pharmacy to reverse |
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345 | 337 | | and rebill the claim in question, and make the reimbursement amount |
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346 | 338 | | change retroactive and effective for all contracted providers; and |
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347 | 339 | | 5. If a below-cost reimbursement appeal is denied, the PBM |
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348 | 340 | | shall provide the reason for the denial, including the National Drug |
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349 | 341 | | Code number from and the specific national or regional wholesalers |
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350 | 342 | | where from which the drug is was available for purchase by the |
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351 | 343 | | dispensing pharmacy at a price below the PBM's reimbursement price |
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352 | 344 | | as of the date the adjudication of the claim was made. If the |
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353 | 345 | | pharmacy benefits manager cannot fails to provide a specific |
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354 | 346 | | national or regional wholesaler where from which the drug can be |
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355 | 347 | | purchased was available for purchas e by the dispensing pharmacy at a |
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356 | 348 | | price below the pharmacy benefits manager's reimbursement price, the |
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357 | 349 | | pharmacy benefits manag er shall immediately adjust the reimbursement |
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358 | 350 | | amount, permit the di spensing pharmacy to reverse and rebill the |
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359 | 351 | | claim in question, and make the reimbursement amount adju stment |
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360 | 352 | | retroactive and effective for all contracted providers . |
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361 | 353 | | B. The pharmacy benefits manager shall not place a drug on a |
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362 | 354 | | MAC list, unless there are at least two therapeutically equivalent, |
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363 | 355 | | multiple-source drugs, generally available for purchase b y |
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364 | 356 | | dispensing retail pharmacies from national or regional wholesale rs |
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365 | 357 | | which are listed as accre dited drug distributors on the National |
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392 | 383 | | |
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393 | 384 | | Association of Boards of Ph armacy (NABP) website or other website as |
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394 | 385 | | recognized and approv ed by the State Board of Pharmacy. |
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395 | 386 | | C. The pharmacy benefits manager shall not require |
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396 | 387 | | accreditation or licensing of provider s, or any entity licensed or |
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397 | 388 | | regulated by the State Board of Pharma cy, other than by the State |
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398 | 389 | | Board of Pharmacy or federal government entity as a condition for |
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399 | 390 | | participation as a network provider. |
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400 | 391 | | D. A pharmacy or pharmacist may decline to provide the |
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401 | 392 | | pharmacist clinical or dispensing services to a patient or pharmacy |
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402 | 393 | | benefits manager if the pharmacy or pharmacist is to be pa id less |
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403 | 394 | | than the pharmacy's cost for providing the pharmacist clinical or |
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404 | 395 | | dispensing services. |
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405 | 396 | | E. The pharmacy benefits manager sha ll provide a dedicated |
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406 | 397 | | telephone number, email address and names of the personnel with |
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407 | 398 | | decision-making authority regarding M AC appeals and pricing. |
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408 | 399 | | SECTION 4. This act shall become effective November 1, 202 2. |
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