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5 | - | An Act | |
6 | - | ENROLLED SENATE | |
7 | - | BILL NO. 1670 By: McCortney, Prieto, Jett, | |
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28 | + | ENGROSSED HOUSE AMENDME NT | |
29 | + | TO | |
30 | + | ENGROSSED SENATE BILL NO . 1670 By: McCortney, Prieto, Jett, | |
8 | 31 | Coleman, Hamilton, and | |
9 | 32 | Alvord of the Senate | |
10 | 33 | ||
11 | 34 | and | |
12 | 35 | ||
13 | 36 | McEntire of the House | |
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17 | 40 | ||
18 | - | An Act relating to pharmacy benefits management; | |
41 | + | ||
42 | + | [ pharmacy benefits management - pharmacy | |
43 | + | reimbursement - rule promulgation - audit - notice | |
44 | + | and reporting - fines and fees - recouped funds - | |
45 | + | emergency ] | |
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52 | + | AMENDMENT NO. 1. Strike the stricken title, enacting clause, and | |
53 | + | entire bill and insert: | |
54 | + | ||
55 | + | ||
56 | + | "An Act relating to pharmacy benefits management; | |
19 | 57 | amending 59 O.S. 2021, Sections 35 6.1, 356.2, 356.3, | |
20 | 58 | 357, 358, and 360, which relate to the Pharmacy Audit | |
21 | 59 | Integrity Act and pharmacy reimbursement; providing | |
22 | 60 | for rule promulgation; modi fying audit notice | |
23 | 61 | requirements; requiring notice and reporting to the | |
24 | 62 | Office of the Attorney General; p roviding for fines | |
25 | 63 | and fees; modifying definitions; requiring certa in | |
26 | 64 | recouped funds from audit to be paid to patients | |
27 | 65 | first; making certain audits null and void; requiring | |
28 | 66 | certain notice to include certain declaration; | |
29 | 67 | modifying definition; modifying reim bursement appeal | |
30 | 68 | process; requiring reimbursement at certain rate | |
31 | 69 | under certain circumstances; updating statutory | |
32 | 70 | references; and declaring an emergency . | |
33 | 71 | ||
34 | 72 | ||
35 | 73 | ||
36 | 74 | ||
37 | - | SUBJECT: Pharmacy Audit Integrity Act | |
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39 | 101 | BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA: | |
40 | - | ||
41 | 102 | SECTION 1. AMENDATORY 59 O.S. 2021, Section 356.1, is | |
42 | 103 | amended to read as follows: | |
43 | - | ||
44 | 104 | Section 356.1. A. For purposes of the Pharmacy Audit Integrity | |
45 | 105 | Act, “pharmacy benefits manager ” or “PBM” means a person, business, | |
46 | 106 | or other entity that performs pharmacy b enefits management. The | |
47 | 107 | term includes a person or entity acting for a PBM in a contractual | |
48 | - | ||
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50 | 108 | or employment relationship in the perfo rmance of pharmacy benefits | |
51 | 109 | management for a managed care compa ny, nonprofit hospital, medical | |
52 | 110 | service organization, insuranc e company, third-party payor, or a | |
53 | 111 | health program administered by a department of this state shall have | |
54 | 112 | the same meaning as in Section 6960 of Title 36 of the Oklahoma | |
55 | 113 | Statutes. | |
56 | - | ||
57 | 114 | B. The purpose of the Pharmacy Audit Integrity Act is to | |
58 | 115 | establish minimum and uniform standards and criteria for the audit | |
59 | 116 | of pharmacy records by or on behalf of certain entities. | |
60 | - | ||
61 | 117 | C. The Pharmacy Audit Integrity Act shall apply to any audit of | |
62 | 118 | the records of a pharmacy conducted by a managed care company, | |
63 | 119 | nonprofit hospital, medi cal service organization, insurance company, | |
64 | 120 | third-party payor, pharmacy benefits manager, a health program | |
65 | 121 | administered by a department of this state, or any entity that | |
66 | 122 | represents these compan ies, groups, or departments. | |
67 | - | ||
68 | 123 | D. The Attorney General may promu lgate rules to implement the | |
69 | 124 | provisions of the Pharmacy Audit Integrity Act. | |
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71 | 151 | SECTION 2. AMENDATORY 59 O.S. 2021, Section 356.2, is | |
72 | 152 | amended to read as follows: | |
73 | - | ||
74 | 153 | Section 356.2. A. The entity conducting an audi t of a pharmacy | |
75 | 154 | shall: | |
76 | - | ||
77 | 155 | 1. Identify and specifically describe the audit and appeal | |
78 | 156 | procedures in the pharmacy contract. Prescription claim | |
79 | 157 | documentation and record -keeping requirements shall not exceed the | |
80 | 158 | requirements set forth by the Oklahoma Pharmacy Act or other | |
81 | 159 | applicable state or federal laws or regulations; | |
82 | - | ||
83 | 160 | 2. Give the pharmacy written notice by certified letter to the | |
84 | 161 | pharmacy and the pharmacy ’s contracting agent, including | |
85 | 162 | identification of specific prescr iption numbers and fill dates to be | |
86 | 163 | audited, at least two (2) weeks fourteen (14) calendar days prior to | |
87 | 164 | conducting the audit, including, but not limited to, an on -site | |
88 | 165 | audit, a desk audit, or a wholesale purchase audit, request for | |
89 | 166 | documentation related t o the dispensing of a prescription drug or | |
90 | 167 | any reimbursed activ ity by a pharmacy provider; provided, however, | |
91 | 168 | that wholesale purchase audits shall require a minimum of thirty | |
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94 | 169 | (30) days’ calendar days’ written notice. For an on-site audit, the | |
95 | 170 | audit date shall be the date the on-site audit occurs. For all | |
96 | 171 | other audit types, the audit date shall be the date the pharmacy | |
97 | 172 | provides the documentation requested in the audit notice. The | |
98 | 173 | pharmacy shall have the opportunity to reschedule the audit no more | |
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99 | 200 | than seven (7) calendar days from the date designated on the | |
100 | 201 | original audit notification; | |
101 | - | ||
102 | 202 | 3. Not interfere with the delivery of pharmacist services to a | |
103 | 203 | patient and shall utilize every reasonable effort to minimize | |
104 | 204 | inconvenience and disruption to pharmacy operatio ns during the audit | |
105 | 205 | process; | |
106 | - | ||
107 | 206 | 4. Conduct any audit involving clini cal or professional | |
108 | 207 | judgment by means of or in consultation with a licensed pharmacist; | |
109 | - | ||
110 | 208 | 5. Not consider as fraud any clerical or record -keeping error, | |
111 | 209 | such as a typographical error, scriven er’s error or computer error, | |
112 | 210 | including, but not limited to, a mis calculated day supply, | |
113 | 211 | incorrectly billed prescription written date or prescription origin | |
114 | 212 | code, and such errors shall not be subject to recoupment. The | |
115 | 213 | pharmacy shall have the right to sub mit amended claims | |
116 | 214 | electronically to correct clerical or record -keeping errors in lieu | |
117 | 215 | of recoupment. To the extent that an audit results in the | |
118 | 216 | identification of any clerical or record -keeping errors such as | |
119 | 217 | typographical errors, scrivener ’s errors or computer errors in a | |
120 | 218 | required document or record, the pharmacy shall not be subject to | |
121 | 219 | recoupment of funds by the pharmacy benefits manager unless the | |
122 | 220 | pharmacy benefits manager can provide proof of intent to commit | |
123 | 221 | fraud. A person shall not be subject to cr iminal penalties for | |
124 | 222 | errors provided for in this paragraph without proof of intent to | |
125 | 223 | commit fraud; | |
126 | 224 | ||
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127 | 250 | 6. Permit a pharmacy to use the records of a hospital, | |
128 | 251 | physician, or other authorized practitioner of the healing arts for | |
129 | 252 | drugs or medicinal supplies writ ten or transmitted by any means of | |
130 | 253 | communication for purposes of v alidating the pharmacy record with | |
131 | 254 | respect to orders or refills of a legend or narcotic drug; | |
132 | - | ||
133 | 255 | 7. Not include the dispensing fee amount or the actual invoice | |
134 | 256 | cost of the prescription dispens ed in a finding of an audit | |
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137 | 257 | recoupment unless a prescription was n ot actually dispensed or a | |
138 | 258 | physician denied authorization of a dispensing order; | |
139 | - | ||
140 | 259 | 8. Audit each pharmacy under identical standards, regularity | |
141 | 260 | and parameters as other similarly situated phar macies and all | |
142 | 261 | pharmacies owned or managed by the pharmacy benefit s manager | |
143 | 262 | conducting or having conducted the audit; | |
144 | - | ||
145 | 263 | 9. Not exceed one (1) year from the date the claim was | |
146 | 264 | submitted to or adjudicated by a managed care company, nonprofit | |
147 | 265 | hospital or medical service organization, insurance company, third- | |
148 | 266 | party payor, pharmacy benefits manager, a health program | |
149 | 267 | administered by a department of this state, or any entity that | |
150 | 268 | represents the companies, groups, or departments for the period | |
151 | 269 | covered by an audit; | |
152 | - | ||
153 | 270 | 10. Not schedule or initiate an audit during the first seven | |
154 | 271 | (7) calendar days of any month unless otherwise consented to by the | |
155 | 272 | pharmacy; | |
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157 | 299 | 11. Disclose to any plan sponsor whose claims were included in | |
158 | 300 | the audit any money recouped in the audit; and | |
159 | - | ||
160 | 301 | 12. Not require pharmacists to break open packaging labeled | |
161 | 302 | “for single-patient-use only”. Packaging labeled “for single- | |
162 | 303 | patient-use only” shall be deemed to be the smallest package size | |
163 | 304 | available; and | |
164 | - | ||
165 | 305 | 13. Upon recoupment of funds from a pharmacy, refund firs t to | |
166 | 306 | the patient the portion of the recovered funds that were orig inally | |
167 | 307 | paid by the patient, provided such funds were part of the | |
168 | 308 | recoupment. | |
169 | - | ||
170 | 309 | B. 1. Any entity that conducts wholesale purchase review | |
171 | 310 | during an audit of a pharmacist or pharmacy shall not require the | |
172 | 311 | pharmacist or pharmacy to pro vide a full dispensing re port. | |
173 | 312 | Wholesaler invoice reviews shall be limited to verification of | |
174 | 313 | purchase inventory specific to the pharmacy claims paid by the | |
175 | 314 | health benefits plan or pharmacy benefits manager conduct ing the | |
176 | 315 | audit. | |
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180 | 316 | 2. Any entity conducting an audit shall not identi fy or label a | |
181 | 317 | prescription claim as an audit discrepancy when: | |
182 | - | ||
183 | 318 | a. the National Drug Code for the dispensed drug is in a | |
184 | 319 | quantity that is a subunit or multiple of the drug | |
185 | 320 | purchased by the pharmacist or pharmacy as supported | |
186 | 321 | by a wholesale invoice, | |
187 | 322 | ||
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188 | 348 | b. the pharmacist or pharmacy dispensed the correct | |
189 | 349 | quantity of the drug according to the prescription, | |
190 | 350 | and | |
191 | - | ||
192 | 351 | c. the drug dispensed by the pharmacist or pharmacy | |
193 | 352 | shares all but the last two digits of the National | |
194 | 353 | Drug Code of the drug reflec ted on the supplier | |
195 | 354 | invoice. | |
196 | - | ||
197 | 355 | 3. An entity conducting an audit shall accept as evidence, | |
198 | 356 | subject to validation, to support the validity of a pharmacy claim | |
199 | 357 | related to a dispensed drug: | |
200 | - | ||
201 | 358 | a. redacted copies of supplier invoices in the | |
202 | 359 | pharmacist’s or pharmacy’s possession, or | |
203 | - | ||
204 | 360 | b. invoices and any supporting documents from any | |
205 | 361 | supplier as authorized by federal or state law to | |
206 | 362 | transfer ownership of the drug acquired by the | |
207 | 363 | pharmacist or pharmacy. | |
208 | - | ||
209 | 364 | 4. An entity conducting a n audit shall provide, no later than | |
210 | 365 | five (5) business calendar days after the date of a request by the | |
211 | 366 | pharmacist or pharmacy, all supporting documents the pharmacist ’s or | |
212 | 367 | pharmacy’s purchase suppliers provided to the health benefits plan | |
213 | 368 | issuer or pharmacy benefits manager. | |
214 | - | ||
215 | 369 | C. A pharmacy shall be allowed to provide th e pharmacy’s | |
216 | 370 | computerized patterned medical records or the records of a hospital, | |
217 | 371 | physician, or other authorized practitioner of the healing arts for | |
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218 | 398 | drugs or medicinal supplies written or t ransmitted by any means of | |
219 | 399 | communication for purposes of supportin g the pharmacy record with | |
220 | 400 | respect to orders or refills of a legend or narcotic drug. | |
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224 | 401 | D. The entity conducting the audit shall not audit more than | |
225 | 402 | fifty prescriptions, with specific date of service, per calendar | |
226 | 403 | year. The annual limit to the number of pr escription claims audited | |
227 | 404 | shall be inclusive of all audits, including any prescription -related | |
228 | 405 | documentation requests from the health insurer, pharmacy benefits | |
229 | 406 | manager or any third -party company conducting audits on behalf of | |
230 | 407 | any health insurer or pharmac y benefits manager during a calendar | |
231 | 408 | year. | |
232 | - | ||
233 | 409 | E. If paper copies of records are requested by the entity | |
234 | 410 | conducting the audit, the entity shall pay twenty -five cents ($0.25) | |
235 | 411 | per page to cover the costs incurred by the pharmacy. The e ntity | |
236 | 412 | conducting the audit shall provide the pharmacy with accurate | |
237 | 413 | instructions, including any required form for obtaining | |
238 | 414 | reimbursement for the copied records. | |
239 | - | ||
240 | 415 | F. The entity conducting the audit shall: | |
241 | - | ||
242 | 416 | 1. Deliver a preliminary audit findings report to the pharmacy | |
243 | 417 | and the pharmacy’s contracting agent within forty-five (45) calendar | |
244 | 418 | days of conducting the audit; | |
245 | - | ||
246 | 419 | 2. Allow the pharmacy at least ninety (90) calendar days | |
247 | 420 | following receipt of the preliminary audit fi ndings report in which | |
248 | 421 | to produce documentation to address any dis crepancy found during the | |
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249 | 448 | audit; provided, however, a pharm acy may request an extension, not | |
250 | 449 | to exceed an additional forty -five (45) calendar days; | |
251 | - | ||
252 | 450 | 3. Deliver a final audit findings report to the pharmacy and | |
253 | 451 | the pharmacy’s contracting agent signed by the auditor within ten | |
254 | 452 | (10) calendar days after receipt of additional documentation | |
255 | 453 | provided by the pharmacy, as provided for in Section 356.3 of this | |
256 | 454 | title; | |
257 | - | ||
258 | 455 | 4. Allow the pharmacy to reverse a nd resubmit claims | |
259 | 456 | electronically within thirty (30) calendar days of receipt of the | |
260 | 457 | final audit report in lieu of the auditing entity recouping | |
261 | 458 | discrepant claim amounts from the pharmacy; | |
262 | - | ||
263 | 459 | 5. Not recoup any disputed funds until after final disposition | |
264 | 460 | of the audit findings, including the appeals process as provided for | |
265 | 461 | in Section 356.3 of this title; and | |
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269 | 462 | 6. Not accrue interest during the audit and appeal period. | |
270 | - | ||
271 | 463 | G. Each entity conducting an audit shall provide a copy of the | |
272 | 464 | final audit results, and a fin al audit report upon request, after | |
273 | 465 | completion of any review proce ss to the plan sponsor. | |
274 | - | ||
275 | 466 | H. 1. The full amount of any recoupment on an audit shall be | |
276 | 467 | refunded to the plan sponsor. Except as provided for in paragraph 2 | |
277 | 468 | of this subsection, a charge or as sessment for an audit shall not be | |
278 | 469 | based, directly or indirectly, on amounts recouped. | |
279 | - | ||
280 | 470 | 2. This subsection does not prevent the entity conducting the | |
281 | 471 | audit from charging or assessing the responsible party, directly or | |
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282 | 498 | indirectly, based on amounts recouped if both of the following | |
283 | 499 | conditions are met: | |
284 | - | ||
285 | 500 | a. the plan sponsor and the entity conducting the audit | |
286 | 501 | have a contract that explicitly s tates the percentage | |
287 | 502 | charge or assessment to the plan sponsor, and | |
288 | - | ||
289 | 503 | b. a commission to an agent or employee of the entity | |
290 | 504 | conducting the audit is not based, directl y or | |
291 | 505 | indirectly, on amoun ts recouped. | |
292 | - | ||
293 | 506 | I. Unless superseded by state or federal law, auditors shall | |
294 | 507 | only have access to previous audit reports on a particular pharmacy | |
295 | 508 | conducted by the auditing entity for the same p harmacy benefits | |
296 | 509 | manager, health plan or insurer. An auditing ven dor contracting | |
297 | 510 | with multiple pharmacy benefits managers or health i nsurance plans | |
298 | 511 | shall not use audit reports or other information gained from an | |
299 | 512 | audit on a pharmacy to conduct another audi t for a different | |
300 | 513 | pharmacy benefits manag er or health insurance pl an. | |
301 | - | ||
302 | 514 | J. Sections A through I of this section shall not apply to any | |
303 | 515 | audit initiated based on or that involves fraud, willful | |
304 | 516 | misrepresentation, or abuse. | |
305 | - | ||
306 | 517 | K. If the Attorney General, after notice and opportunity for | |
307 | 518 | hearing, finds that the entity conducting the audit fa iled to follow | |
308 | 519 | any of the requirements pursuant to the Pharmacy Audit Integrity | |
309 | 520 | Act, the audit shall be considered null and void. Any monies | |
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312 | 521 | recouped from a null and void audit shall be returned to the | |
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313 | 548 | affected pharmacy within fourteen (14) calendar days. Any violation | |
314 | 549 | of this section by a pharmacy benefit s manager or auditing entity | |
315 | 550 | shall be deemed a violation of the Pharmacy Audit Integrity Act. | |
316 | - | ||
317 | 551 | SECTION 3. AMENDATORY 59 O.S. 2021, Section 356.3, is | |
318 | 552 | amended to read as follows: | |
319 | - | ||
320 | 553 | Section 356.3. A. Each entity conducting an audit sh all | |
321 | 554 | establish a written appeals proce ss under which a pharmacy may | |
322 | 555 | appeal an unfavorable preliminary audit report and/or final audit | |
323 | 556 | report to the entity. | |
324 | - | ||
325 | 557 | B. Following an appeal, if the entity finds tha t an unfavorable | |
326 | 558 | audit report or any portion thereof is unsubstantiated, the entity | |
327 | 559 | shall dismiss the audit report or the unsubstan tiated portion of the | |
328 | 560 | audit report without any further action. | |
329 | - | ||
330 | 561 | C. Any final audit report, following the final audit appeal | |
331 | 562 | period, with a finding of fraud or willful misrepresen tation shall | |
332 | 563 | be referred to the distr ict attorney having proper jurisdiction o r | |
333 | 564 | the Attorney General for prosecution upon completion of the appeals | |
334 | 565 | process. | |
335 | - | ||
336 | 566 | D. This act does not apply to any audit , review or | |
337 | 567 | investigation that is For any audit initiated based on or that | |
338 | 568 | involves fraud, willful misrepres entation, or abuse, the auditing | |
339 | 569 | entity shall provide, in writing, at the time of the audit, a clear | |
340 | 570 | and conspicuous declaration to the pharmacy being audited that the | |
341 | 571 | audit is being conducted under suspicion of fraud, willful | |
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342 | 598 | misrepresentation, or abu se and a statement of fac ts that supports | |
343 | 599 | the reasonable suspicion . | |
344 | - | ||
345 | 600 | E. Any entity conducting an audit that is based on or involves | |
346 | 601 | fraud, willful misrepresen tation, or abuse shall provide to the | |
347 | 602 | Office of the Attorney General: | |
348 | - | ||
349 | 603 | 1. Notice at least two (2) calendar days prior to beginning | |
350 | 604 | performance of an audit pursuant to this section; | |
351 | - | ||
352 | 605 | 2. A preliminary report within thirty (30) calendar days of | |
353 | 606 | performing the audit pursuant to this section; and | |
354 | - | ||
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356 | - | ||
357 | 607 | 3. A final report within thirty (30) calendar days following | |
358 | 608 | the closure of the final appeal period for an audit performed | |
359 | 609 | pursuant to this section. | |
360 | - | ||
361 | 610 | F. The Attorney General , authorized employees, and examiners | |
362 | 611 | shall have access to any pharmacy benefits manager’s files and | |
363 | 612 | records that may relate to an audit that is based on or involves | |
364 | 613 | fraud, willful misrepresentation, or abuse. | |
365 | - | ||
366 | 614 | G. The Attorney General may levy a civil or administrative fine | |
367 | 615 | of not less than One Hundred Dollars ($100.00) and not greater than | |
368 | 616 | Ten Thousand Dollars ($10,000.00) for each violation of t his section | |
369 | 617 | and assess any other penalty or remedy authorized by law . | |
370 | - | ||
371 | 618 | SECTION 4. AMENDATORY 59 O.S. 2021, Section 357, is | |
372 | 619 | amended to read as follows: | |
373 | - | ||
374 | 620 | Section 357. A. As used in this act Sections 357 through 360 | |
375 | 621 | of this title: | |
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376 | 647 | ||
377 | 648 | 1. “Covered entity” means a nonprofit hospital or medical | |
378 | 649 | service organization, for-profit hospital or medical service | |
379 | 650 | organization, insurer, health coverage benefit plan or, health | |
380 | 651 | maintenance organization ; a, health program administered by the | |
381 | 652 | state in the capacity o f provider of providing health coverage;, or | |
382 | 653 | an employer, labor union, or other entity organized in the state | |
383 | 654 | group of persons that provides health coverage to covered | |
384 | 655 | individuals who are employe d or reside in the persons in this state. | |
385 | 656 | This term does not include a health benefit plan that provides | |
386 | 657 | coverage only for accidental injury, specified disease, hospital | |
387 | 658 | indemnity, disability income, or ot her limited benefit health | |
388 | 659 | insurance policies and contracts that do not include prescriptio n | |
389 | 660 | drug coverage; | |
390 | - | ||
391 | 661 | 2. “Covered individual” means a member, participant, enrollee, | |
392 | 662 | contract holder or policy holder or beneficiary of a covered entity | |
393 | 663 | who is provided health coverage by the covered entity. A covered | |
394 | 664 | individual includes any dependent or othe r person provided he alth | |
395 | 665 | coverage through a policy, contract or plan for a covere d | |
396 | 666 | individual; | |
397 | - | ||
398 | - | ||
399 | - | ENR. S. B. NO. 1670 Page 10 | |
400 | 667 | 3. “Department” means the Oklahoma Insurance Department; | |
401 | - | ||
402 | 668 | 4. “Maximum allowable cost” or, “MAC”, or “MAC list” means the | |
403 | 669 | list of drug products delineating the m aximum per-unit reimbursement | |
404 | 670 | for multiple-source prescription drugs, medical pro duct, or device; | |
405 | 671 | ||
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406 | 697 | 5. “Multisource drug product reimbursement ” (reimbursement) | |
407 | 698 | means the total amount paid to a pharmacy inclusive of a ny reduction | |
408 | 699 | in payment to the pharmacy, excluding prescripti on dispense fees; | |
409 | - | ||
410 | 700 | 6. “Office” means the Office of the Attorn ey General; | |
411 | - | ||
412 | 701 | 7. “Pharmacy benefits management” means a service provided to | |
413 | 702 | covered entities to facilitate the provision of prescriptio n drug | |
414 | 703 | benefits to covered individuals wi thin the state, incl uding | |
415 | 704 | negotiating pricing and other terms with drug manufactu rers and | |
416 | 705 | providers. Pharmacy benefits management may include any or all of | |
417 | 706 | the following services: | |
418 | - | ||
419 | 707 | a. claims processing, retail netwo rk management and | |
420 | 708 | payment of claims to ph armacies for prescri ption drugs | |
421 | 709 | dispensed to covered individuals, | |
422 | - | ||
423 | 710 | b. clinical formulary development and management | |
424 | 711 | services, or | |
425 | - | ||
426 | 712 | c. rebate contracting and administrat ion, | |
427 | - | ||
428 | 713 | d. certain patient compliance, therapeutic intervention | |
429 | 714 | and generic substitution programs, or | |
430 | - | ||
431 | 715 | e. disease management pr ograms; | |
432 | - | ||
433 | 716 | 7. 8. “Pharmacy benefits manager ” or “PBM” means a person, | |
434 | 717 | business, or other entity that performs pharmacy benefits | |
435 | 718 | management. The term includes shall include a person or entity | |
436 | 719 | acting for on behalf of a PBM in a contractual or employment | |
437 | 720 | relationship in the performance of pharmacy benefits managem ent for | |
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438 | 747 | a managed care company, nonprofit hospital, medical service | |
439 | 748 | organization, insurance company, third-party payor, or a health | |
440 | 749 | program administered by an agency or department of this state; | |
441 | - | ||
442 | - | ||
443 | - | ENR. S. B. NO. 1670 Page 11 | |
444 | 750 | 8. 9. “Plan sponsor” means the employers, insurance companie s, | |
445 | 751 | unions and health maintenance organizations or an y other entity | |
446 | 752 | responsible for establishing, maintaining, or administering a health | |
447 | 753 | benefit plan on behalf of covered individuals; and | |
448 | - | ||
449 | 754 | 9. 10. “Provider” means a pharmacy licensed by the State Board | |
450 | 755 | of Pharmacy, or an agent or representative of a pharmacy, including, | |
451 | 756 | but not limited to, the pharmacy’s contracting agent, which | |
452 | 757 | dispenses prescription drugs or devices to co vered individuals. | |
453 | - | ||
454 | 758 | B. Nothing in the definition of pharmacy benefits management or | |
455 | 759 | pharmacy benefits manager in the Patient’s Right to Pharmacy Choice | |
456 | 760 | Act, Pharmacy Audit Integrity Act, or Sections 357 through 360 of | |
457 | 761 | this title shall deem an employer a “pharmacy benefits manager” of | |
458 | 762 | its own self-funded health benefit plan, except, to the ex tent | |
459 | 763 | permitted by applicable law, where the employer , without the | |
460 | 764 | utilization of a third party and unrelated to the employer’s own | |
461 | 765 | pharmacy: | |
462 | - | ||
463 | 766 | a. negotiates directly with d rug manufacturers, | |
464 | - | ||
465 | 767 | b. processes claims on behalf of its members, or | |
466 | - | ||
467 | 768 | c. manages its own retail network of pharmacies. | |
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468 | 795 | ||
469 | 796 | SECTION 5. AMENDATORY 59 O.S. 2021, Section 358, is | |
470 | 797 | amended to read as f ollows: | |
471 | - | ||
472 | 798 | Section 358. A. In order to pro vide pharmacy benefits | |
473 | 799 | management or any of the services included under the definiti on of | |
474 | 800 | pharmacy benefits management in this state, a pha rmacy benefits | |
475 | 801 | manager or any entity acting as one in a contractual or emplo yment | |
476 | 802 | relationship for a covered entity s hall first obtain a license from | |
477 | 803 | the Oklahoma Insurance Department, and the Departme nt may charge a | |
478 | 804 | fee for such licensure. | |
479 | - | ||
480 | 805 | B. The Department shall establish, b y regulation, licensure | |
481 | 806 | procedures, required disclosur es for pharmacy benefits managers | |
482 | 807 | (PBMs) and other rules as may be necessary for carrying out and | |
483 | 808 | enforcing the provisions of this act this title. The licensure | |
484 | 809 | procedures shall, at a minimum, include the completion of an | |
485 | 810 | application form that shall include the name and address of an agent | |
486 | - | ||
487 | - | ENR. S. B. NO. 1670 Page 12 | |
488 | 811 | for service of process, the payment of a requisite fee, and eviden ce | |
489 | 812 | of the procurement of a surety bond. | |
490 | - | ||
491 | 813 | C. The Department or the Office of the Attorney General may | |
492 | 814 | subpoena witnesses and information. Its compliance officers may | |
493 | 815 | take and copy records for investigative use and pros ecutions. | |
494 | 816 | Nothing in this subsection shall limit the Office of the Attorney | |
495 | 817 | General from using its investigative demand authority to investigate | |
496 | 818 | and prosecute violations of the law. | |
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497 | 844 | ||
498 | 845 | D. The Department may suspend, revoke or refuse to issue or | |
499 | 846 | renew a license for noncompliance with any of the provisions hereby | |
500 | 847 | established or with the rules promulgated by the Department; for | |
501 | 848 | conduct likely to mislead, deceive or defraud the public or the | |
502 | 849 | Department; for unfair or decepti ve business practices or for | |
503 | 850 | nonpayment of a an application or renewal fee or fine. The | |
504 | 851 | Department may also levy administrative fines for each count of | |
505 | 852 | which a PBM has been convicted in a Department hearing. | |
506 | - | ||
507 | 853 | E. 1. The Office of the Attorney General, after notice and | |
508 | 854 | opportunity for hearing, may instruct the Insurance Commission er | |
509 | 855 | that the PBM’s license be censured, suspended, or revoked for | |
510 | 856 | conduct likely to mislead, deceive, or defraud the public or the | |
511 | 857 | State of Oklahoma; or for unfair or deceptive busi ness practices, or | |
512 | 858 | for any violation of the Patient’s Right to Pharmacy Choi ce Act, the | |
513 | 859 | Pharmacy Audit Integrity Act, or Sections 357 through 360 of this | |
514 | 860 | title. The Office of the Attorney General may also levy | |
515 | 861 | administrative fines for each count of which a PBM has been | |
516 | 862 | convicted following a hearing before the Attorney Ge neral. If the | |
517 | 863 | Attorney General makes such instruction, the Commissioner shall | |
518 | 864 | enforce the instructed action within thirty (30) calendar days. | |
519 | - | ||
520 | 865 | 2. In addition to or in lieu of any censure, suspension, or | |
521 | 866 | revocation of a license by the Commissioner, the Attorney Gen eral | |
522 | 867 | may levy a civil or administrative fine of not less than One Hundred | |
523 | 868 | Dollars ($100.00) and not greater than Ten Thousand Dollars | |
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524 | 895 | ($10,000.00) for each violation of this subsec tion and/or assess any | |
525 | 896 | other penalty or remedy authorized by this section. For purposes of | |
526 | 897 | this section, each day a PBM fails to comply with an investiga tion | |
527 | 898 | or inquiry may be considered a separate violation. | |
528 | - | ||
529 | - | ||
530 | - | ENR. S. B. NO. 1670 Page 13 | |
531 | 899 | F. The Attorney General may promulgate rules to implement the | |
532 | 900 | provisions of Sections 357 through 360 of this title. | |
533 | - | ||
534 | 901 | SECTION 6. AMENDATORY 59 O.S. 2 021, Section 360, is | |
535 | 902 | amended to read as follows: | |
536 | - | ||
537 | 903 | Section 360. A. The pharmacy benefit s manager shall, with | |
538 | 904 | respect to contracts between a pharmacy benefits manager and a | |
539 | 905 | provider, including a pharmacy s ervice administrative organization: | |
540 | - | ||
541 | 906 | l. Include in such contracts the specific sources utilized to | |
542 | 907 | determine the maximum allowable cost (MAC) pricing of the pharmacy, | |
543 | 908 | update MAC pricing at least every seven (7) calendar days, and | |
544 | 909 | establish a process for pr oviders to readily access the MAC list | |
545 | 910 | specific to that provider; | |
546 | - | ||
547 | 911 | 2. In order to place a drug on the MAC list, ensure that the | |
548 | 912 | drug is listed as “A” or “B” rated in the most recen t version of the | |
549 | 913 | FDA’s Approved Drug Products with Therapeutic Equivalence | |
550 | 914 | Evaluations, also known as the Orange Book, and the d rug is | |
551 | 915 | generally available for purchase by pharmacies in the state from | |
552 | 916 | national or regional wholesalers and is not obsolete; | |
553 | - | ||
554 | 917 | 3. Ensure dispensing fees are not included in the calculation | |
555 | 918 | of MAC price reimbursement to pharmacy providers; | |
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557 | 945 | 4. Provide a reasonable administration app eals procedure to | |
558 | 946 | allow a provider, a provider ’s representative and a pharmacy service | |
559 | 947 | administrative organization to contest reimbursement amounts within | |
560 | 948 | fourteen (14) business calendar days of the final adjusted payment | |
561 | 949 | date. The pharmacy benefits manager shall not prevent the pharmacy | |
562 | 950 | or the pharmacy service administrative organization from filing | |
563 | 951 | reimbursement appeals in an electronic batch format. The pharmacy | |
564 | 952 | benefits manager must respond to a provi der, a provider’s | |
565 | 953 | representative and a pharmacy service administrative organization | |
566 | 954 | who have contested a reimbur sement amount through this procedure | |
567 | 955 | within ten (10) business calendar days. The pharmacy benefits | |
568 | 956 | manager must respond in an electronic batch format to reimbursement | |
569 | 957 | appeals filed in an electronic batch format. The pharmacy benefits | |
570 | 958 | manager shall not require a pharmacy or pharmacy services | |
571 | 959 | administrative organization to log into a system to upload | |
572 | 960 | individual claim app eals or to download individual appea l responses. | |
573 | - | ||
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575 | 961 | If a price update is warranted, the pharmacy benefits manager shall | |
576 | 962 | make the change in th e reimbursement amount, permit the dispen sing | |
577 | 963 | pharmacy to reverse and rebill the claim in question, and make the | |
578 | 964 | reimbursement amount change retroactive and effective for all | |
579 | 965 | contracted providers; and | |
580 | - | ||
581 | 966 | 5. If a below-cost reimbursement appeal is denied, th e PBM | |
582 | 967 | shall provide the reason for the den ial, including the National Drug | |
583 | 968 | Code (NDC) number from, and the name of, the specific national or | |
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584 | 995 | regional wholesalers doing business in this state where the drug is | |
585 | 996 | currently in stock and available for purchase by the dispensing | |
586 | 997 | pharmacy at a price below the PBM’s reimbursement price. If the | |
587 | 998 | pharmacy benefits manager cannot pro vide a specific national or | |
588 | 999 | regional wholesaler where the drug can be pu rchased by the | |
589 | 1000 | dispensing pharmacy at a price below the pharmacy be nefits manager’s | |
590 | 1001 | reimbursement price If the NDC number provided by the pharmacy | |
591 | 1002 | benefits manager is not available bel ow the acquisition cost | |
592 | 1003 | obtained from the pharmaceutical wholesaler from whom the dispensing | |
593 | 1004 | pharmacy purchases the majority of the prescri ption drugs that are | |
594 | 1005 | dispensed, the pharmacy benefits manager shall immediately adjust | |
595 | 1006 | the reimbursement amount, perm it the dispensing pharmacy to reverse | |
596 | 1007 | and rebill the claim in question, and make the reimbursement amount | |
597 | 1008 | adjustment retroactive and effect ive for all contracted providers. | |
598 | - | ||
599 | 1009 | B. The reimbursement appeal requirements in this section shall | |
600 | 1010 | apply to all drugs, medical products, or devices reimbursed | |
601 | 1011 | according to any payment methodology, including, but not limited to: | |
602 | - | ||
603 | 1012 | 1. Average acquisition cost , including the National Average | |
604 | 1013 | Drug Acquisition Cost; | |
605 | - | ||
606 | 1014 | 2. Average manufacturer price; | |
607 | - | ||
608 | 1015 | 3. Average wholesale price ; | |
609 | - | ||
610 | 1016 | 4. Brand effective rate or generic effective rate ; | |
611 | - | ||
612 | 1017 | 5. Discount indexing; | |
613 | - | ||
614 | 1018 | 6. Federal upper limits; | |
615 | 1019 | ||
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616 | 1045 | 7. Wholesale acquisition cost ; and | |
617 | - | ||
618 | - | ENR. S. B. NO. 1670 Page 15 | |
619 | - | ||
620 | 1046 | 8. Any other term that a pharmacy benefits manager or an | |
621 | 1047 | insurer of a health benefit plan may use to establish reimbursement | |
622 | 1048 | rates to a pharmacist or pharmacy for pharmacist servic es. | |
623 | - | ||
624 | 1049 | C. The pharmacy benefits manager shall not place a drug on a | |
625 | 1050 | MAC list, unless there are at least two therapeutica lly equivalent, | |
626 | 1051 | multiple-source drugs, generally available for purch ase by | |
627 | 1052 | dispensing retail pharmacies from national or regional whol esalers. | |
628 | - | ||
629 | 1053 | C. D. In the event that a drug is placed on the FDA Drug | |
630 | 1054 | Shortages Database, pharmacy benefits managers shall re imburse | |
631 | 1055 | claims to pharmacies at no less than the wholesale acquisition cost | |
632 | 1056 | for the specific NDC number being di spensed. | |
633 | - | ||
634 | 1057 | E. The pharmacy benefits manager shall not require | |
635 | 1058 | accreditation or licensing of providers, o r any entity licensed or | |
636 | 1059 | regulated by the State Board of Pharmacy, other than by the State | |
637 | 1060 | Board of Pharmacy or federal government entity as a condition for | |
638 | 1061 | participation as a network provider. | |
639 | - | ||
640 | 1062 | D. F. A pharmacy or pharmacist may decline to provide the | |
641 | 1063 | pharmacist clinical or dispensing services t o a patient or pharmacy | |
642 | 1064 | benefits manager if the pharmacy or pharmacist is to be paid less | |
643 | 1065 | than the pharmacy’s cost for providing the p harmacist clinical or | |
644 | 1066 | dispensing services. | |
645 | 1067 | ||
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646 | 1093 | E. G. The pharmacy benefits manager s hall provide a dedicated | |
647 | 1094 | telephone number, email address and names of the personnel with | |
648 | 1095 | decision-making authority regarding MAC appeals and pricing. | |
649 | - | ||
650 | 1096 | SECTION 7. It being immediately necessary for the preservation | |
651 | 1097 | of the public peace, healt h or safety, an emergency is hereby | |
652 | 1098 | declared to exist, by reason whereof this act shall take effect and | |
1099 | + | be in full force from and after its passage and a pproval." | |
1100 | + | ||
1101 | + | Passed the House of Representa tives the 25th day of April, 2024. | |
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1107 | + | Presiding Officer of the House of | |
1108 | + | Representatives | |
1109 | + | ||
1110 | + | ||
1111 | + | Passed the Senate the ____ day of _______ ___, 2024. | |
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1114 | + | ||
1115 | + | ||
1116 | + | ||
1117 | + | Presiding Officer of the Senate | |
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1145 | + | ENGROSSED SENATE | |
1146 | + | BILL NO. 1670 By: McCortney, Prieto, Jett, | |
1147 | + | Coleman, Hamilton, and | |
1148 | + | Alvord of the Senate | |
1149 | + | ||
1150 | + | and | |
1151 | + | ||
1152 | + | McEntire of the House | |
1153 | + | ||
1154 | + | ||
1155 | + | ||
1156 | + | ||
1157 | + | [ pharmacy benefits management - pharmacy | |
1158 | + | reimbursement - rule promulgation - audit - notice | |
1159 | + | and reporting - fines and fees - recouped funds - | |
1160 | + | emergency ] | |
1161 | + | ||
1162 | + | ||
1163 | + | ||
1164 | + | ||
1165 | + | BE IT ENACTED BY THE PEOPLE OF THE STATE OF OK LAHOMA: | |
1166 | + | SECTION 8. AMENDATORY 59 O.S. 2021, Section 356.1, is | |
1167 | + | amended to read as follows: | |
1168 | + | Section 356.1. A. For purposes of the Pharmacy Audit Integrity | |
1169 | + | Act, “pharmacy benefits manager ” or “PBM” means a person, business, | |
1170 | + | or other entity that performs pharmacy benefits management. The | |
1171 | + | term includes a person or entity acting for a PBM in a contractual | |
1172 | + | or employment relationship in the perfo rmance of pharmacy benefits | |
1173 | + | management for a managed care company, nonprofit hospital, medic al | |
1174 | + | service organization, insurance company, third -party payor, or a | |
1175 | + | health program administered by a department of this state. | |
1176 | + | B. The purpose of the Pharmacy Audit Integrity Act is to | |
1177 | + | establish minimum and uniform standards and criteria for the audit | |
1178 | + | of pharmacy records by or on behalf of certain entities. | |
1179 | + | ||
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1205 | + | C. The Pharmacy Audit Integrity Act shall apply to any audit of | |
1206 | + | the records of a pharmacy conducted by a manag ed care company, | |
1207 | + | nonprofit hospital, medi cal service organization, insurance company, | |
1208 | + | third-party payor, pharmacy benefits manager, a health program | |
1209 | + | administered by a department of this state, or any entity that | |
1210 | + | represents these companies, groups, or depar tments. | |
1211 | + | D. The Attorney General may promulgate rules to implement the | |
1212 | + | provisions of the Pha rmacy Audit Integrity Act. | |
1213 | + | SECTION 9. AMENDATORY 59 O.S. 2021, Section 356.2, is | |
1214 | + | amended to read as follows: | |
1215 | + | Section 356.2. A. The entit y conducting an audit of a pharmacy | |
1216 | + | shall: | |
1217 | + | 1. Identify and specifically describe the audit and appeal | |
1218 | + | procedures in the pharmacy contract. Prescription claim | |
1219 | + | documentation and record -keeping requirements shall not exceed the | |
1220 | + | requirements set forth by the Oklahoma Pharmacy Act or other | |
1221 | + | applicable state or federal laws or regulations; | |
1222 | + | 2. Give the pharmacy written notice by certified letter to the | |
1223 | + | pharmacy and the pharmacy ’s contracting agent, including | |
1224 | + | identification of specific prescription numbers and fi ll dates to be | |
1225 | + | audited, at least two (2) weeks fourteen (14) calendar days prior to | |
1226 | + | conducting the audit, including, but not limited to, an on -site | |
1227 | + | audit, a desk audit, or a wholesale purchase audit, request for | |
1228 | + | documentation related to the dispensing of a prescription drug or | |
1229 | + | ||
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1255 | + | any reimbursed activity by a pharmacy provider; provided, however, | |
1256 | + | that wholesale purchase audits shall require a minimum of thirty | |
1257 | + | (30) calendar days’ written notice. For an on-site audit, the audit | |
1258 | + | date shall be the date the on -site audit occurs. For all other | |
1259 | + | audit types, the audit date shall be the date the pharmacy pr ovides | |
1260 | + | the documentation requested in the audit notice. The pharmacy shall | |
1261 | + | have the opportunity to reschedule the audit no more than seven (7) | |
1262 | + | calendar days from the date designated on the original audit | |
1263 | + | notification; | |
1264 | + | 3. Not interfere with the delivery o f pharmacist services to a | |
1265 | + | patient and shall utilize every reasonable effort to minimize | |
1266 | + | inconvenience and disruption to pharmacy operations during the audit | |
1267 | + | process; | |
1268 | + | 4. Conduct any audit involving clinic al or professional | |
1269 | + | judgment by means of or in consu ltation with a licensed pharmacist; | |
1270 | + | 5. Not consider as fraud any clerical or record -keeping error, | |
1271 | + | such as a typographical error, scrivener ’s error or computer err or, | |
1272 | + | including, but not limited to, a miscalculated day supply, | |
1273 | + | incorrectly billed prescripti on written date or prescription origin | |
1274 | + | code, and such errors shall not be subject to recoupment. The | |
1275 | + | pharmacy shall have the right to submit amended claims | |
1276 | + | electronically to correct clerical or record -keeping errors in lieu | |
1277 | + | of recoupment. To the extent t hat an audit results in the | |
1278 | + | identification of any clerical or record -keeping errors such as | |
1279 | + | ||
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1305 | + | typographical errors, scrivener ’s errors or computer errors in a | |
1306 | + | required document or record, the pharmacy shall not be subject to | |
1307 | + | recoupment of funds by the pharma cy benefits manager unless the | |
1308 | + | pharmacy benefits manager can provide proof of intent to commit | |
1309 | + | fraud. A person shall not be subject to criminal penalties for | |
1310 | + | errors provided for in this paragraph without proof of intent to | |
1311 | + | commit fraud; | |
1312 | + | 6. Permit a pharmacy to use the records of a hospital, | |
1313 | + | physician, or other authorized practitioner of the healing arts for | |
1314 | + | drugs or medicinal supplies written or transmitted by any means of | |
1315 | + | communication for purposes of validating the pharmacy record with | |
1316 | + | respect to orders or refills of a legend or narcotic drug; | |
1317 | + | 7. Not include the dispensing fee amount or the actual invoice | |
1318 | + | cost of the prescription dispensed in a finding of an audi t | |
1319 | + | recoupment unless a prescription was no t actually dispensed or a | |
1320 | + | physician denied authoriz ation of a dispensing order; | |
1321 | + | 8. Audit each pharmacy under identical standards, regularity | |
1322 | + | and parameters as other similarly situated pharmacies and all | |
1323 | + | pharmacies owned or managed by the pharmacy benefits manager | |
1324 | + | conducting or having conducted the audit; | |
1325 | + | 9. Not exceed one (1) year from the date the claim was | |
1326 | + | submitted to or adjudicated by a managed care company, nonprofit | |
1327 | + | hospital or medical service organization, i nsurance company, third - | |
1328 | + | party payor, pharmacy benefits manager, a health program | |
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1355 | + | administered by a department of this state, or any entity that | |
1356 | + | represents the companies, groups, or departments for the period | |
1357 | + | covered by an audit; | |
1358 | + | 10. Not schedule or initia te an audit during the first seven | |
1359 | + | (7) calendar days of any month unless otherwise consented to by the | |
1360 | + | pharmacy; | |
1361 | + | 11. Disclose to any plan sponsor whose claims were included in | |
1362 | + | the audit any money recouped in the audit; and | |
1363 | + | 12. Not require pharmacists to break open packaging labeled | |
1364 | + | “for single-patient-use only”. Packaging labeled “for single- | |
1365 | + | patient-use only” shall be deemed to be the smallest package size | |
1366 | + | available; and | |
1367 | + | 13. Upon recoupment of funds from a pharmacy, refund first to | |
1368 | + | the patient the porti on of the recovered funds that were originally | |
1369 | + | paid by the patient. | |
1370 | + | B. 1. Any entity that conducts wholesale purchase review | |
1371 | + | during an audit of a pharmacist or pharmacy shall not require the | |
1372 | + | pharmacist or pharmacy to provide a full dispensing report. | |
1373 | + | Wholesaler invoice reviews shall be limited to verification of | |
1374 | + | purchase inventory specific to the pharmacy claims paid by the | |
1375 | + | health benefits plan or pharmacy benefits manager conducting the | |
1376 | + | audit. | |
1377 | + | 2. Any entity conducting an audit shall not identify or lab el a | |
1378 | + | prescription claim as an audit discrepancy when: | |
1379 | + | ||
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1405 | + | a. the National Drug Code for the disp ensed drug is in a | |
1406 | + | quantity that is a subunit or multiple of the drug | |
1407 | + | purchased by the pharmacist or pharmacy as supported | |
1408 | + | by a wholesale invoice, | |
1409 | + | b. the pharmacist or pharmacy dispensed the correct | |
1410 | + | quantity of the drug according to the prescription, | |
1411 | + | and | |
1412 | + | c. the drug dispensed by the pharmacist or pharmacy | |
1413 | + | shares all but the last two digits of the National | |
1414 | + | Drug Code of the drug reflected on the supplier | |
1415 | + | invoice. | |
1416 | + | 3. An entity conducting an audit shall accept as evidence, | |
1417 | + | subject to validation, to support the validity of a pharmacy claim | |
1418 | + | related to a dispensed drug: | |
1419 | + | a. redacted copies of supplier invoices in the | |
1420 | + | pharmacist’s or pharmacy’s possession, or | |
1421 | + | b. invoices and any supporting documents from any | |
1422 | + | supplier as authorized by federal or state law to | |
1423 | + | transfer ownership of the drug acquired by the | |
1424 | + | pharmacist or pharmacy. | |
1425 | + | 4. An entity conducting an audit shall provide, no later than | |
1426 | + | five (5) business days after the date of a request by the pharmacist | |
1427 | + | or pharmacy, all supporting documents the pharmacist ’s or pharmacy’s | |
1428 | + | ||
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1454 | + | purchase suppliers provided to the health benefits plan issuer or | |
1455 | + | pharmacy benefits manager. | |
1456 | + | C. A pharmacy shall be allowed to provide the pharmacy ’s | |
1457 | + | computerized patterned medical records or the records of a hospital, | |
1458 | + | physician, or other authoriz ed practitioner of the healing arts for | |
1459 | + | drugs or medicinal supplies written or transmitted by any means of | |
1460 | + | communication for purposes of supporting the pharmacy rec ord with | |
1461 | + | respect to orders or refills of a legend or narcotic drug. | |
1462 | + | D. The entity conductin g the audit shall not audit more than | |
1463 | + | fifty prescriptions, with specific date of service, per calendar | |
1464 | + | year. The annual limit to the number of prescription claims audited | |
1465 | + | shall be inclusive of all audits, including any prescription -related | |
1466 | + | documentation requests from the health insurer, pharmacy benefits | |
1467 | + | manager or any third -party company conducting audits on behalf of | |
1468 | + | any health insurer or pharmacy benefits manager during a calendar | |
1469 | + | year. | |
1470 | + | E. If paper copies of records are requested by the entity | |
1471 | + | conducting the audit, the entity shall pay twenty -five cents ($0.25) | |
1472 | + | per page to cover the costs incurred by the pharmacy. The entity | |
1473 | + | conducting the audit shall provide th e pharmacy with accurate | |
1474 | + | instructions, including any required form for obtaining | |
1475 | + | reimbursement for the copied records. | |
1476 | + | F. The entity conducting the audit shall: | |
1477 | + | ||
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1503 | + | 1. Deliver a preliminary audit findings report to the pharmacy | |
1504 | + | and the pharmacy’s contracting agent within forty-five (45) calendar | |
1505 | + | days of conducting the audit; | |
1506 | + | 2. Allow the pharmacy at least ninety (90) calendar days | |
1507 | + | following receipt of the preliminary audit findings report in which | |
1508 | + | to produce documentation to address any discrepancy found dur ing the | |
1509 | + | audit; provided, however, a pharm acy may request an extension, not | |
1510 | + | to exceed an additional forty-five (45) calendar days; | |
1511 | + | 3. Deliver a final audit findings report to the pharmacy and | |
1512 | + | the pharmacy’s contracting agent signed by the auditor within te n | |
1513 | + | (10) calendar days after receipt of additional documentation | |
1514 | + | provided by the pharmacy, as provided for in Section 356.3 of this | |
1515 | + | title; | |
1516 | + | 4. Allow the pharmacy to reverse and resubmit claims | |
1517 | + | electronically within thirty (30) days of receipt of the final au dit | |
1518 | + | report in lieu of the auditing entity recouping discrepant claim | |
1519 | + | amounts from the pharma cy; | |
1520 | + | 5. Not recoup any disputed funds until after final disposition | |
1521 | + | of the audit findings, including the appeals process as provided for | |
1522 | + | in Section 356.3 of this ti tle; and | |
1523 | + | 6. Not accrue interest during the audit and appeal period. | |
1524 | + | G. Each entity conduct ing an audit shall provide a copy of the | |
1525 | + | final audit results, and a final audit report upon request, after | |
1526 | + | completion of any review process to the plan sponsor. | |
1527 | + | ||
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1553 | + | H. 1. The full amount of any recoupment on an audit shall be | |
1554 | + | refunded to the plan sponsor. E xcept as provided for in paragraph 2 | |
1555 | + | of this subsection, a charge or assessment for an audit shall not be | |
1556 | + | based, directly or indirectly, on amounts recouped. | |
1557 | + | 2. This subsection does not prevent the entity conducting the | |
1558 | + | audit from charging or assessing th e responsible party, directly or | |
1559 | + | indirectly, based on amounts recouped if both of the following | |
1560 | + | conditions are met: | |
1561 | + | a. the plan sponsor and the entity conducting th e audit | |
1562 | + | have a contract that explicitly s tates the percentage | |
1563 | + | charge or assessment to the pl an sponsor, and | |
1564 | + | b. a commission to an agent or employee of the entity | |
1565 | + | conducting the audit is not based, directly or | |
1566 | + | indirectly, on amounts recouped. | |
1567 | + | I. Unless superseded by state or federal law, auditors shall | |
1568 | + | only have access to previous audit reports o n a particular pharmacy | |
1569 | + | conducted by the auditing entity for the same pharmacy benefits | |
1570 | + | manager, health plan or insurer. An auditing vendor contracting | |
1571 | + | with multiple pharmacy benefits managers or health i nsurance plans | |
1572 | + | shall not use audit reports or other information gained from an | |
1573 | + | audit on a pharmacy to conduct another audit for a different | |
1574 | + | pharmacy benefits manager or health insurance plan. | |
1575 | + | J. An audit shall be c onsidered null and void if the entity | |
1576 | + | conducting the audit fails to follow any of the requir ements under | |
1577 | + | ||
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1603 | + | this section. Any violation of this section by a pharmacy benefits | |
1604 | + | manager or auditing entity shall be deemed a violation of the | |
1605 | + | Pharmacy Audit Integr ity Act. | |
1606 | + | SECTION 10. AMENDATORY 59 O.S. 2021, Section 356.3, is | |
1607 | + | amended to read as follows: | |
1608 | + | Section 356.3. A. Each entity conducting an audit shall | |
1609 | + | establish a written appeals process under which a pharmacy may | |
1610 | + | appeal an unfavorable preliminary audit report and/or final audit | |
1611 | + | report to the entity. | |
1612 | + | B. Following an appea l, if the entity finds that an unfavorable | |
1613 | + | audit report or any portion thereof is unsubstantiated, the entity | |
1614 | + | shall dismiss the audit report or the unsubstantiated portion of the | |
1615 | + | audit report without any f urther action. | |
1616 | + | C. Any final audit report, followin g the final audit appeal | |
1617 | + | period, with a finding of fraud or willful misrepresentation shall | |
1618 | + | be referred to the district attorney having proper jurisdiction or | |
1619 | + | the Attorney General for prosecution upon completion of the appeals | |
1620 | + | process. | |
1621 | + | D. This act does section and Section 356.2 of this title do not | |
1622 | + | apply to any audit, review or investigation that is initiated based | |
1623 | + | on or that involves fraud, willful misrepresentatio n or abuse so | |
1624 | + | long as the auditing entity provides in writing at the time of the | |
1625 | + | audit, a clear and conspicuous declaration that the audit is being | |
1626 | + | conducted under suspicion of fraud, willful misrepresentation, or | |
1627 | + | ||
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1653 | + | abuse and a statement of facts that suppor ts the reasonable | |
1654 | + | suspicion. Any monies recouped from a null and void audit shall be | |
1655 | + | returned to the affected pharmacy within fourteen (14) calendar | |
1656 | + | days. | |
1657 | + | E. Any entity conducting an audit based on or that involves | |
1658 | + | fraud, willful misrepresentation, or ab use shall provide to the | |
1659 | + | Office of the Attorney General: | |
1660 | + | 1. Notice at least two (2) busines s days prior to beginning | |
1661 | + | performance of an audit under this section; | |
1662 | + | 2. A preliminary report within thirty (30) days of performing | |
1663 | + | the audit; and | |
1664 | + | 3. A final report within thirty (30) days following the closure | |
1665 | + | of the final audit appeal period. | |
1666 | + | F. The Attorney General shall have unrestricted access to any | |
1667 | + | documents relevant to an audit that is based on or that involves | |
1668 | + | fraud, willful misrepresentation, or abuse. | |
1669 | + | G. The Attorney General may levy a civil or administrative fine | |
1670 | + | not less than One Hundred Dollars ($100.00) and not greater than Ten | |
1671 | + | Thousand Dollars ($10,000.00) for each violation of this section and | |
1672 | + | assess any other penalty or remedy authorized by law. | |
1673 | + | SECTION 11. AMENDATORY 59 O.S. 2021, Section 357, is | |
1674 | + | amended to read as follows: | |
1675 | + | Section 357. As used in this act section through Section 360 of | |
1676 | + | this title: | |
1677 | + | ||
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1702 | + | ||
1703 | + | 1. “Covered entity” means a nonprofit hospital or medical | |
1704 | + | service organization, insurer, health coverage benefit plan, or | |
1705 | + | health maintenance organization ; a, health program administered by | |
1706 | + | the state in the capacity of provider of providing health coverage;, | |
1707 | + | or an employer, labor union, or other entity organized in the state | |
1708 | + | group of persons that provides health coverage to covered | |
1709 | + | individuals who are employed or resi de in the persons in this state. | |
1710 | + | This term does not include a health benefit plan that provides | |
1711 | + | coverage only for accidental injury, specified disease, hospital | |
1712 | + | indemnity, disability income, or other limi ted benefit health | |
1713 | + | insurance policies and contracts that do not include prescription | |
1714 | + | drug coverage; | |
1715 | + | 2. “Covered individual” means a member, participant, enrollee, | |
1716 | + | contract holder or policy holder or beneficiary of a covered entity | |
1717 | + | who is provided health coverage by the covered entity. A covered | |
1718 | + | individual includes any dependent or other person provided health | |
1719 | + | coverage through a policy, contract or plan for a covered | |
1720 | + | individual; | |
1721 | + | 3. “Department” means the Oklahoma Insurance Department; | |
1722 | + | 4. “Maximum allowable cost”, or “MAC”, or “MAC list” means the | |
1723 | + | list of drug products delineating the maximum per -unit reimbursement | |
1724 | + | for multiple-source prescription drugs, medical product products, or | |
1725 | + | device devices including, but not limited to: | |
1726 | + | ||
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1751 | + | ||
1752 | + | a. average acquisition cost, including the national drug | |
1753 | + | acquisition cost, | |
1754 | + | b. average manufacturer price, | |
1755 | + | c. average wholesale price, | |
1756 | + | d. brand effective rate or generic effective rate, | |
1757 | + | e. discount indexing, | |
1758 | + | f. federal upper limits, | |
1759 | + | g. wholesale acquisition cost, and | |
1760 | + | h. any other term that a pharmacy benefits manager or an | |
1761 | + | insurer of a health benefit plan may use to establish | |
1762 | + | reimbursement rates to a pharmacist or pharmacy for | |
1763 | + | pharmacist services; | |
1764 | + | 5. “Multisource drug product reimbursement ” (reimbursement) | |
1765 | + | means the total amount paid to a pharmacy inclusive of any reduction | |
1766 | + | in payment to the pharmacy, excluding prescription dispense fees; | |
1767 | + | 6. “Office” means the Office of the Attorney General; | |
1768 | + | 7. “Pharmacy benefits management ” means a service provided to | |
1769 | + | covered entities to facilitate the provision of prescription drug | |
1770 | + | benefits to covered individuals within the state, including | |
1771 | + | negotiating pricing and other terms with drug manufacturers and | |
1772 | + | providers. Pharmacy benefits management may include any or all of | |
1773 | + | the following services: | |
1774 | + | ||
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1799 | + | ||
1800 | + | a. claims processing, retail network management and | |
1801 | + | payment of claims to pharmacies for prescription drugs | |
1802 | + | dispensed to covered individuals, | |
1803 | + | b. administration or management of pharmacy discount | |
1804 | + | cards or programs, | |
1805 | + | c. clinical formulary development and management | |
1806 | + | services, | |
1807 | + | c. d. rebate contracting and administrati on, | |
1808 | + | d. e. certain patient compliance, therapeutic intervention | |
1809 | + | and generic substitution programs, or | |
1810 | + | e. f. administration or management of mail -order pharmacy | |
1811 | + | programs, or | |
1812 | + | g. disease management programs; | |
1813 | + | 7. 8. “Pharmacy benefits manager ” or “PBM” means a person, | |
1814 | + | business, or other entity that performs pharmacy benefits | |
1815 | + | management. The term includes shall include a person or entity | |
1816 | + | acting for on behalf of a PBM in a contractual or employment | |
1817 | + | relationship in the performance of pharmacy benefits management f or | |
1818 | + | a managed care company, nonprofit hospital, medical service | |
1819 | + | organization, insurance company, third -party payor, or a health | |
1820 | + | program administered by an agency or department of this state; | |
1821 | + | 8. 9. “Plan sponsor” means the employers, insurance companies, | |
1822 | + | unions and health maintenance organizations or any other entity | |
1823 | + | ||
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1849 | + | responsible for establishing, maintaining, or administering a health | |
1850 | + | benefit plan on behalf of covered individuals; and | |
1851 | + | 9. 10. “Provider” means a pharmacy licensed by the State Board | |
1852 | + | of Pharmacy, or an agent or representative of a pharmacy, including, | |
1853 | + | but not limited to, the pharmacy ’s contracting agent, which | |
1854 | + | dispenses prescription drugs or devices to co vered individuals. | |
1855 | + | SECTION 12. AMENDATORY 59 O.S. 2021, Section 358 , is | |
1856 | + | amended to read as follows: | |
1857 | + | Section 358. A. In order to provide pharmacy benefits | |
1858 | + | management or any of the services included under the definition of | |
1859 | + | pharmacy benefits management in this state, a pha rmacy benefits | |
1860 | + | manager or any entity acting as one in a contractual or employment | |
1861 | + | relationship for a covered entity shall first obtain a license from | |
1862 | + | the Oklahoma Insurance Department, and the Department may charge a | |
1863 | + | fee for such licensure. | |
1864 | + | B. The Department shall establish, by regulation, licensure | |
1865 | + | procedures, required disclosures for pharmacy benefits managers | |
1866 | + | (PBMs) and other rules as may be necessary for carrying out and | |
1867 | + | enforcing the provisions of this act the Oklahoma Pharmacy Act . The | |
1868 | + | licensure procedures shall, at a minimum, include the completion of | |
1869 | + | an application form that shall include the name and address of an | |
1870 | + | agent for service of process, the payment of a requisite fee, and | |
1871 | + | evidence of the procurement of a surety bond. | |
1872 | + | ||
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1897 | + | ||
1898 | + | C. The Department may subpoena witnesses and information. Its | |
1899 | + | compliance officers may take and copy records for investigative use | |
1900 | + | and prosecutions. Nothing in this subsection shall limit the Office | |
1901 | + | of the Attorney General from using it s investigative demand | |
1902 | + | authority to investigate and prosecute violations of the law. | |
1903 | + | D. The Department may suspend, revoke or refuse to issue or | |
1904 | + | renew a license for noncompliance with any of the provisions hereby | |
1905 | + | established or with the rules promulgated by the Department; for | |
1906 | + | conduct likely to mislead, deceive or defraud the public or the | |
1907 | + | Department; for unfair or deceptive business practices or for | |
1908 | + | nonpayment of a renewal fee or fine. The Department may also levy | |
1909 | + | administrative fines for each count of w hich a PBM has been | |
1910 | + | convicted in a Depart ment hearing. | |
1911 | + | E. The Attorney General may promulga te rules to implement the | |
1912 | + | provisions of Sections 357 through 360 of this title. | |
1913 | + | SECTION 13. AMENDATORY 59 O.S. 2021, Section 360, is | |
1914 | + | amended to read as follows: | |
1915 | + | Section 360. A. The pharmacy benefits manager shall, with | |
1916 | + | respect to contracts between a pharmacy benefits manager and a | |
1917 | + | provider, including a pharmacy service administrative organization: | |
1918 | + | l. Include in such contracts the specific sources utilized to | |
1919 | + | determine the maximum allowable cost (MAC) pricing of the pharmacy, | |
1920 | + | update MAC pricing at least every seven (7) calendar days, and | |
1921 | + | ||
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1947 | + | establish a process for providers to readily access the MAC list | |
1948 | + | specific to that provider; | |
1949 | + | 2. In order to place a drug on the MAC list, ensure that the | |
1950 | + | drug is listed as “A” or “B” rated in the most recent version of the | |
1951 | + | FDA’s Approved Drug Products with Therapeutic Equivalence | |
1952 | + | Evaluations, also known as the Orange Book, and the drug is | |
1953 | + | generally available for purchase by pharmacies in the state f rom | |
1954 | + | national or regional wholesalers and is not obs olete; | |
1955 | + | 3. Ensure dispensing fees are not included in the calculation | |
1956 | + | of MAC price reimbursement to pharmacy providers; | |
1957 | + | 4. Provide a reasonable administration appe als procedure to | |
1958 | + | allow a provider, a provider ’s representative and a pharmacy service | |
1959 | + | administrative organization to contest reimbursement amounts within | |
1960 | + | fourteen (14) business days of the final adjusted payment date. The | |
1961 | + | pharmacy benefits manager shall n ot prevent the pharmacy or the | |
1962 | + | pharmacy service administrative organization from filing | |
1963 | + | reimbursement appeals in an electronic batch format. The pharmacy | |
1964 | + | benefits manager must respond to a provider, a provider ’s | |
1965 | + | representative and a pharmacy service admin istrative organization | |
1966 | + | who have contested a reimbursement amount through this procedure | |
1967 | + | within ten (10) business days. The pharmacy benefits manager must | |
1968 | + | respond in an electronic batch format to reimbursement appeals filed | |
1969 | + | in an electronic batch format. The pharmacy benefits manager shall | |
1970 | + | not require a pharmacy or pharmacy services administrati ve | |
1971 | + | ||
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1997 | + | organization to log into a system to upload individual claim appeals | |
1998 | + | or to download individual appeal responses. If a price update is | |
1999 | + | warranted, the pharmacy be nefits manager shall make the change in | |
2000 | + | the reimbursement amount, permit the dispensing phar macy to reverse | |
2001 | + | and rebill the claim in question, and make the reimbursement amount | |
2002 | + | change retroactive and effective for all contracted providers; and | |
2003 | + | 5. If a below-cost reimbursement appeal is denied, th e PBM | |
2004 | + | shall provide the reason for the denial, incl uding the National Drug | |
2005 | + | Code (NDC) number from and the name of the specific national or | |
2006 | + | regional wholesalers doing business in this state where the drug is | |
2007 | + | currently in stock and available for purchase by the dispensing | |
2008 | + | pharmacy at a price below the PBM ’s reimbursement price. If the | |
2009 | + | pharmacy benefits manager cannot provide a specific national or | |
2010 | + | regional wholesaler where the drug can be purchased by the | |
2011 | + | dispensing pharmacy at a price below the pharmacy ben efits manager’s | |
2012 | + | reimbursement price If the NDC number provided by the pharmacy | |
2013 | + | benefits manager is not available below the acquisition cost | |
2014 | + | obtained from the pharmaceutical wholesaler from whom the dispensing | |
2015 | + | pharmacy purchases the majority of the prescription drugs that are | |
2016 | + | dispensed, the pharmacy benefit s manager shall immediately adjust | |
2017 | + | the reimbursement amount, permit the dispensing pharmacy to reverse | |
2018 | + | and rebill the claim in question, and make the reimbursement amount | |
2019 | + | adjustment retroactive and effecti ve for all contracted providers. | |
2020 | + | ||
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2046 | + | B. The pharmacy benefits manager shall not place a drug on a | |
2047 | + | MAC list, unless there are at least two therapeutically equivalent, | |
2048 | + | multiple-source drugs, generally available for purch ase by | |
2049 | + | dispensing retail pharmacies from national or regional wholesalers. | |
2050 | + | C. In the event that a drug is placed on the FDA Drug Shortage s | |
2051 | + | Database, pharmacy benefits managers shall reimburse claims to | |
2052 | + | pharmacies at no less than the wholesale acquisition cost for the | |
2053 | + | specific NDC number being di spensed. | |
2054 | + | D. The pharmacy benefits manager shall no t require | |
2055 | + | accreditation or licensing of providers, or any entity licensed or | |
2056 | + | regulated by the State Board of Pharmacy, other than by the State | |
2057 | + | Board of Pharmacy or federal government entity as a condition for | |
2058 | + | participation as a network provider. | |
2059 | + | D. E. A pharmacy or pharmacist may decline to provide the | |
2060 | + | pharmacist clinical or dispensing services to a patient or pharmacy | |
2061 | + | benefits manager if the pharmacy or pharmacist is to be paid less | |
2062 | + | than the pharmacy’s cost for providing the pharmacist clinical or | |
2063 | + | dispensing services. | |
2064 | + | E. F. The pharmacy benefits manager shall provide a dedicated | |
2065 | + | telephone number, email address and names of the personnel with | |
2066 | + | decision-making authority regarding MAC appeals and pricing. | |
2067 | + | SECTION 14. It being immediately neces sary for the preservation | |
2068 | + | of the public peace, health or safety, an emergency is hereby | |
2069 | + | ||
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2094 | + | ||
2095 | + | declared to exist, by reason whereof this act shall take effect and | |
653 | 2096 | be in full force from and after its passage and a pproval. | |
654 | - | ||
655 | - | ||
656 | - | ||
657 | - | ||
658 | - | ENR. S. B. NO. 1670 Page 16 | |
659 | - | Passed the Senate the 14th day of May, 2024. | |
2097 | + | Passed the Senate the 12th day of March, 2024. | |
660 | 2098 | ||
661 | 2099 | ||
662 | 2100 | ||
663 | 2101 | Presiding Officer of the Senate | |
664 | 2102 | ||
665 | 2103 | ||
666 | - | Passed the House of Representatives the 25th day of April, 2024. | |
2104 | + | Passed the House of Representatives the ____ day of __________, | |
2105 | + | 2024. | |
667 | 2106 | ||
668 | 2107 | ||
669 | 2108 | ||
670 | 2109 | Presiding Officer of the House | |
671 | 2110 | of Representatives | |
672 | 2111 | ||
673 | - | OFFICE OF THE GOVERNOR | |
674 | - | Received by the Office of the Governor this _______ _____________ | |
675 | - | day of _________________ __, 20_______, at _______ o'clock _______ M. | |
676 | - | By: _________________________________ | |
677 | - | Approved by the Governor of the State of Oklahoma this _________ | |
678 | - | day of _________________ __, 20_______, at _______ o'clock _______ M. | |
679 | - | ||
680 | - | _________________________________ | |
681 | - | Governor of the State of Oklahoma | |
682 | - | ||
683 | - | ||
684 | - | OFFICE OF THE SECRETARY OF STATE | |
685 | - | Received by the Office of the Secretary of State this _______ ___ | |
686 | - | day of _________________ _, 20 _______, at _______ o'clock _______ M. | |
687 | - | By: _________________________________ | |
2112 | + |