Old | New | Differences | |
---|---|---|---|
1 | 1 | ||
2 | 2 | ||
3 | + | ENGR. H. A. to ENGR. S. B. NO. 513 Page 1 1 | |
4 | + | 2 | |
5 | + | 3 | |
6 | + | 4 | |
7 | + | 5 | |
8 | + | 6 | |
9 | + | 7 | |
10 | + | 8 | |
11 | + | 9 | |
12 | + | 10 | |
13 | + | 11 | |
14 | + | 12 | |
15 | + | 13 | |
16 | + | 14 | |
17 | + | 15 | |
18 | + | 16 | |
19 | + | 17 | |
20 | + | 18 | |
21 | + | 19 | |
22 | + | 20 | |
23 | + | 21 | |
24 | + | 22 | |
25 | + | 23 | |
26 | + | 24 | |
3 | 27 | ||
4 | - | ||
5 | - | An Act | |
6 | - | ENROLLED SENATE | |
7 | - | BILL NO. 513 By: Rosino and Garvin of the | |
28 | + | ENGROSSED HOUSE AMENDME NT | |
29 | + | TO | |
30 | + | ENGROSSED SENATE BILL NO . 513 By: Rosino and Garvin of the | |
8 | 31 | Senate | |
9 | 32 | ||
10 | 33 | and | |
11 | 34 | ||
12 | - | Miller, Fugate, Stinson, | |
13 | - | Sneed, Burns, Davis, | |
14 | - | Newton, McEntire, Williams, | |
15 | - | Cantrell, McCall, Bennett, | |
16 | - | Hilbert, Stark, Randleman, | |
17 | - | Marti, Roe, Tedford, Lowe | |
18 | - | (Dick), Munson, Boles, | |
19 | - | Manger, Roberts, and Baker | |
35 | + | Miller, Fugate, and Stinson | |
20 | 36 | of the House | |
37 | + | ||
38 | + | ||
21 | 39 | ||
22 | 40 | ||
23 | 41 | ||
24 | 42 | ||
25 | 43 | ||
26 | 44 | An Act relating to biomarker testing; defining terms; | |
27 | 45 | requiring coverage of biomarker testing under certain | |
28 | 46 | conditions; requiring certain contract to be provided | |
29 | 47 | with policy; directing plan to limit disruptions in | |
30 | 48 | care with certain evidence; requiring plan to publish | |
31 | 49 | accessible process on certain website for certain | |
32 | 50 | requests; construing provision; amending 56 O.S. | |
33 | 51 | 2021, Section 4002.6, as amended by Section 10, | |
34 | 52 | Chapter 395, O.S.L. 2022 (56 O.S. Supp. 2022, Section | |
35 | 53 | 4002.6), which relates to the state Medicaid program; | |
36 | 54 | clarifying certain prio r authorization requirement; | |
37 | 55 | updating statutory language; defining terms; | |
38 | 56 | requiring certain coverage and provision of biomarker | |
39 | 57 | testing; stipulating prior au thorization requirements | |
40 | 58 | for biomarker testing; directing creation of process | |
41 | 59 | to request exceptions to certain coverage policies; | |
42 | 60 | providing for codification; and providing an | |
43 | 61 | effective date. | |
44 | 62 | ||
45 | 63 | ||
46 | 64 | ||
47 | 65 | ||
66 | + | AUTHOR: Add the following House Coauthor s: Sneed, Burns, Davis, | |
67 | + | Newton, McEntire, Williams, Cantrell, McCall, Bennett, | |
68 | + | Hilbert, Stark, Randleman, Marti, Roe, Tedford, Lowe | |
69 | + | (Dick), Munson, Boles, Manger, Roberts, and Baker | |
48 | 70 | ||
49 | - | ENR. S. B. NO. 513 Page 2 | |
50 | 71 | ||
51 | - | SUBJECT: Biomarker testing | |
72 | + | AMENDMENT NO. 1. Strike the title, enacting clause, and entire bill | |
73 | + | and insert: | |
74 | + | ||
75 | + | ||
76 | + | ENGR. H. A. to ENGR. S. B. NO. 513 Page 2 1 | |
77 | + | 2 | |
78 | + | 3 | |
79 | + | 4 | |
80 | + | 5 | |
81 | + | 6 | |
82 | + | 7 | |
83 | + | 8 | |
84 | + | 9 | |
85 | + | 10 | |
86 | + | 11 | |
87 | + | 12 | |
88 | + | 13 | |
89 | + | 14 | |
90 | + | 15 | |
91 | + | 16 | |
92 | + | 17 | |
93 | + | 18 | |
94 | + | 19 | |
95 | + | 20 | |
96 | + | 21 | |
97 | + | 22 | |
98 | + | 23 | |
99 | + | 24 | |
100 | + | ||
101 | + | "An Act relating to biomarker testing; defining | |
102 | + | terms; requiring coverage of biomarker testing under | |
103 | + | certain conditions; requiring certain contract to be | |
104 | + | provided with policy; directing plan to limit | |
105 | + | disruptions in care with certa in evidence; requiring | |
106 | + | plan to publish accessible process on certain website | |
107 | + | for certain requests; construing provision; amending | |
108 | + | 56 O.S. 2021, Section 4002.6, as amended by Section | |
109 | + | 10, Chapter 395, O.S.L. 2022 (56 O.S. Supp. 2022, | |
110 | + | Section 4002.6), which relates to the state Medicaid | |
111 | + | program; clarifying certain prio r authorization | |
112 | + | requirement; updating statutory language; defining | |
113 | + | terms; requiring certain coverage and provision of | |
114 | + | biomarker testing; stipulating prior authorization | |
115 | + | requirements for biomarke r testing; directing | |
116 | + | creation of process to request exceptions to certain | |
117 | + | coverage policies; providing for codification; and | |
118 | + | providing an effective date. | |
119 | + | ||
120 | + | ||
121 | + | ||
52 | 122 | ||
53 | 123 | BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA: | |
54 | - | ||
55 | 124 | SECTION 1. NEW LAW A new section of law to be codified | |
56 | 125 | in the Oklahoma Statutes as Section 6060.5a of Title 36, unless | |
57 | 126 | there is created a duplication in numbering, reads as follows: | |
58 | - | ||
59 | 127 | A. As used in this section: | |
60 | - | ||
61 | 128 | 1. "Biomarker" means a biological molecule found in blood, | |
62 | 129 | other body fluids, or tissues that is a sign of a normal or abnormal | |
63 | 130 | process, or of a condition or disease. A biomarker may be u sed to | |
64 | 131 | see how well the body responds to a treatment for a disease or | |
65 | 132 | condition or for other purposes . Biomarkers shall include but are | |
66 | 133 | not limited to gene m utation or protein expression; | |
67 | - | ||
68 | 134 | 2. "Biomarker testing" means the analysis of a patient’s | |
69 | 135 | tissue, blood, or other biospecimen for the presence of a biomarker. | |
136 | + | ||
137 | + | ENGR. H. A. to ENGR. S. B. NO. 513 Page 3 1 | |
138 | + | 2 | |
139 | + | 3 | |
140 | + | 4 | |
141 | + | 5 | |
142 | + | 6 | |
143 | + | 7 | |
144 | + | 8 | |
145 | + | 9 | |
146 | + | 10 | |
147 | + | 11 | |
148 | + | 12 | |
149 | + | 13 | |
150 | + | 14 | |
151 | + | 15 | |
152 | + | 16 | |
153 | + | 17 | |
154 | + | 18 | |
155 | + | 19 | |
156 | + | 20 | |
157 | + | 21 | |
158 | + | 22 | |
159 | + | 23 | |
160 | + | 24 | |
161 | + | ||
70 | 162 | Biomarker testing shall include but not be limited to single-analyte | |
71 | 163 | tests, multiplex panel tests, gene or protein expression, and whole | |
72 | 164 | exome, whole genome, and whole transcriptome sequencing; | |
73 | - | ||
74 | 165 | 3. "Clinical utility" means the test result provides | |
75 | 166 | information that is used in the formulation of a treatment or | |
76 | 167 | monitoring strategy that informs a patient's outcome and impacts the | |
77 | 168 | clinical decision. Th e most appropriate test may include both | |
78 | 169 | information that is actionable and some information that cannot be | |
79 | 170 | immediately used in the formulation of a clinical decision ; | |
80 | - | ||
81 | 171 | 4. "Consensus statement" means a statement that: | |
82 | - | ||
83 | 172 | a. is developed by an independent, multidisciplinary | |
84 | 173 | panel of experts that use a transparent methodolo gy | |
85 | 174 | and reporting structure that includes a conflict of | |
86 | 175 | interest policy, | |
87 | - | ||
88 | 176 | b. is based on the best available evidence for the | |
89 | 177 | purpose of optimizing clinical care outcomes , and | |
90 | - | ||
91 | 178 | c. is aimed at specific clinical circumstances; | |
92 | - | ||
93 | - | ENR. S. B. NO. 513 Page 3 | |
94 | - | ||
95 | 179 | 5. "Health benefit plan" means a plan as defined pursuant to | |
96 | 180 | Section 6060.4 of Title 36 of the Oklahoma Statutes; and | |
97 | - | ||
98 | 181 | 6. "Nationally recognized clinical practice guidelines" means | |
99 | 182 | evidence-based clinical practice guidelines that: | |
100 | - | ||
101 | 183 | a. are developed by independent organizations or medical | |
102 | 184 | professional societies using a transparent methodology | |
185 | + | ||
186 | + | ENGR. H. A. to ENGR. S. B. NO. 513 Page 4 1 | |
187 | + | 2 | |
188 | + | 3 | |
189 | + | 4 | |
190 | + | 5 | |
191 | + | 6 | |
192 | + | 7 | |
193 | + | 8 | |
194 | + | 9 | |
195 | + | 10 | |
196 | + | 11 | |
197 | + | 12 | |
198 | + | 13 | |
199 | + | 14 | |
200 | + | 15 | |
201 | + | 16 | |
202 | + | 17 | |
203 | + | 18 | |
204 | + | 19 | |
205 | + | 20 | |
206 | + | 21 | |
207 | + | 22 | |
208 | + | 23 | |
209 | + | 24 | |
210 | + | ||
103 | 211 | and reporting structure and a conflict of interest | |
104 | 212 | policy, and | |
105 | - | ||
106 | 213 | b. establish standards of care that are informed by a | |
107 | 214 | systemic review of evi dence and an assessment of the | |
108 | 215 | benefits and costs of alternative care options that | |
109 | 216 | includes recommendations intended to optimize patient | |
110 | 217 | care. | |
111 | - | ||
112 | 218 | B. Any health benefit pla n, including the Oklahoma Employees | |
113 | 219 | Insurance Plan, that is offered, issued, or renewed in this state on | |
114 | 220 | or after the effective date of this act shall provide coverage for | |
115 | 221 | biomarker testing. A contract provided with a health benefit plan | |
116 | 222 | under this section shall include biomarker testing for the purpose | |
117 | 223 | of diagnosis, treatment, appropriate management, or ongoing | |
118 | 224 | monitoring of an insured’s disease or condition to guide treatment | |
119 | 225 | decisions when the biomarker test provides clinical utility as | |
120 | 226 | demonstrated by medical and scientific evidence including, but not | |
121 | 227 | limited to: | |
122 | - | ||
123 | 228 | 1. Labeled indications for tests that are approved or cleared | |
124 | 229 | by the United States Food and D rug Administration; | |
125 | - | ||
126 | 230 | 2. Indicated tests for a drug that is approved by the United | |
127 | 231 | States Food and Drug Administration; | |
128 | - | ||
129 | 232 | 3. Warnings and precautions o n United States Food and Drug | |
130 | 233 | Administration-approved drug labels; | |
234 | + | ||
235 | + | ENGR. H. A. to ENGR. S. B. NO. 513 Page 5 1 | |
236 | + | 2 | |
237 | + | 3 | |
238 | + | 4 | |
239 | + | 5 | |
240 | + | 6 | |
241 | + | 7 | |
242 | + | 8 | |
243 | + | 9 | |
244 | + | 10 | |
245 | + | 11 | |
246 | + | 12 | |
247 | + | 13 | |
248 | + | 14 | |
249 | + | 15 | |
250 | + | 16 | |
251 | + | 17 | |
252 | + | 18 | |
253 | + | 19 | |
254 | + | 20 | |
255 | + | 21 | |
256 | + | 22 | |
257 | + | 23 | |
258 | + | 24 | |
131 | 259 | ||
132 | 260 | 4. Centers for Medicare and Medicaid S ervices national coverage | |
133 | 261 | determinations or Medicare administrative contractor local coverage | |
134 | 262 | determinations; or | |
135 | - | ||
136 | - | ||
137 | - | ENR. S. B. NO. 513 Page 4 | |
138 | 263 | 5. Nationally recognized clinical pr actice guidelines and | |
139 | 264 | consensus statements. | |
140 | - | ||
141 | 265 | C. A health benefit plan shall ensure that coverage is provid ed | |
142 | 266 | in a manner that limits disruptions in care, including the need for | |
143 | 267 | multiple biopsies and biospeci men samples. | |
144 | - | ||
145 | 268 | D. An insured and a prescribing practitioner shall have access | |
146 | 269 | to a clear, readily available, and convenient proc ess to request an | |
147 | 270 | exception to a coverage policy of a health benefit plan under this | |
148 | 271 | subsection. The process shall be readily accessible on the plan’s | |
149 | 272 | website. This subsection shall not be construed to require a | |
150 | 273 | separate process if the health benefit pla n’s existing process | |
151 | 274 | complies with this subsection. | |
152 | - | ||
153 | 275 | SECTION 2. AMENDATORY 56 O.S. 2021, Section 4002.6, a s | |
154 | 276 | amended by Section 10, Chapter 395, O.S.L. 2022 (56 O.S. Supp. 2022, | |
155 | 277 | Section 4002.6), is amended to read as follows: | |
156 | - | ||
157 | 278 | Section 4002.6 A. A contracted entity shall meet all | |
158 | 279 | requirements established by the Oklahoma Health Care Authority | |
159 | 280 | pertaining to prior authorizations. The Authority shall establish | |
160 | 281 | requirements that ensure timely determinations by contracted | |
161 | 282 | entities when prior authorizations are required including expedited | |
283 | + | ||
284 | + | ENGR. H. A. to ENGR. S. B. NO. 513 Page 6 1 | |
285 | + | 2 | |
286 | + | 3 | |
287 | + | 4 | |
288 | + | 5 | |
289 | + | 6 | |
290 | + | 7 | |
291 | + | 8 | |
292 | + | 9 | |
293 | + | 10 | |
294 | + | 11 | |
295 | + | 12 | |
296 | + | 13 | |
297 | + | 14 | |
298 | + | 15 | |
299 | + | 16 | |
300 | + | 17 | |
301 | + | 18 | |
302 | + | 19 | |
303 | + | 20 | |
304 | + | 21 | |
305 | + | 22 | |
306 | + | 23 | |
307 | + | 24 | |
308 | + | ||
162 | 309 | review in urgent and emergent cases that at a minimum meet the | |
163 | 310 | criteria of this section. | |
164 | - | ||
165 | 311 | B. A contracted entity shall make a determination on a request | |
166 | 312 | for an authorization of the transfer of a hospital inpatient to a | |
167 | 313 | post-acute care or long-term acute care facility within twenty-four | |
168 | 314 | (24) hours of receipt of the request. | |
169 | - | ||
170 | 315 | C. A contracted entity shall make a determination on a request | |
171 | 316 | for any member who is not hospitalized at the time of the request | |
172 | 317 | within seventy-two (72) hours of receipt of the request; provided, | |
173 | 318 | that if the request does not include sufficient or adequate | |
174 | 319 | documentation, the review and determination shall occur within a | |
175 | 320 | time frame and in accordance with a process established by the | |
176 | 321 | Authority. The process established by the Authority pursuant to | |
177 | 322 | this subsection shall include a time frame of at least forty-eight | |
178 | 323 | (48) hours within which a provider may submit the necessary | |
179 | 324 | documentation. | |
180 | - | ||
181 | - | ENR. S. B. NO. 513 Page 5 | |
182 | - | ||
183 | 325 | D. A contracted entity shall make a determination on a request | |
184 | 326 | for services for a hospitalized member including, but not limited | |
185 | 327 | to, acute care inpatient services or equipment necessary to | |
186 | 328 | discharge the member from an inpatient facility within one (1) | |
187 | 329 | business day of receipt of the request. | |
188 | - | ||
189 | 330 | E. Notwithstanding the provisions of subsection C of this | |
190 | 331 | section, a contracted entity shall make a determination on a request | |
191 | 332 | as expeditiously as necessary and, in any event, within twenty-four | |
333 | + | ||
334 | + | ENGR. H. A. to ENGR. S. B. NO. 513 Page 7 1 | |
335 | + | 2 | |
336 | + | 3 | |
337 | + | 4 | |
338 | + | 5 | |
339 | + | 6 | |
340 | + | 7 | |
341 | + | 8 | |
342 | + | 9 | |
343 | + | 10 | |
344 | + | 11 | |
345 | + | 12 | |
346 | + | 13 | |
347 | + | 14 | |
348 | + | 15 | |
349 | + | 16 | |
350 | + | 17 | |
351 | + | 18 | |
352 | + | 19 | |
353 | + | 20 | |
354 | + | 21 | |
355 | + | 22 | |
356 | + | 23 | |
357 | + | 24 | |
358 | + | ||
192 | 359 | (24) hours of receipt of the request for service if adhering to the | |
193 | 360 | provisions of subsection C or D of this section could jeopardize the | |
194 | 361 | member’s life, health or ability to attain, maintain or regain | |
195 | 362 | maximum function. In the event of a medically emergent matter, the | |
196 | 363 | contracted entity shall not impose limitations on providers in | |
197 | 364 | coordination of post-emergent stabilization health care including | |
198 | 365 | pre-certification or prior authorization. | |
199 | - | ||
200 | 366 | F. Notwithstanding any other provision of this section, a | |
201 | 367 | contracted entity shall make a determination on a request for | |
202 | 368 | inpatient behavioral health s ervices within twenty-four (24) hours | |
203 | 369 | of receipt of the request. | |
204 | - | ||
205 | 370 | G. A contracted entity shall make a determination on a request | |
206 | 371 | for covered prescription drugs that are required to be prior | |
207 | 372 | authorized by the Authority within twenty-four (24) hours of receipt | |
208 | 373 | of the request. The contracted entity shall not require prior | |
209 | 374 | authorization on any covered prescription drug for which the | |
210 | 375 | Authority does not require prior authorization. | |
211 | - | ||
212 | 376 | H. A contracted entity shall make a dete rmination on a request | |
213 | 377 | for coverage of biomarker testing in accordan ce with Section 3 of | |
214 | 378 | this act. | |
215 | - | ||
216 | 379 | I. Upon issuance of an adverse determination on a prior | |
217 | 380 | authorization request under subsection B of this section, the | |
218 | 381 | contracted entity shall provide the requesting provider, within | |
219 | 382 | seventy-two (72) hours of receipt of suc h issuance, with reasonable | |
383 | + | ||
384 | + | ENGR. H. A. to ENGR. S. B. NO. 513 Page 8 1 | |
385 | + | 2 | |
386 | + | 3 | |
387 | + | 4 | |
388 | + | 5 | |
389 | + | 6 | |
390 | + | 7 | |
391 | + | 8 | |
392 | + | 9 | |
393 | + | 10 | |
394 | + | 11 | |
395 | + | 12 | |
396 | + | 13 | |
397 | + | 14 | |
398 | + | 15 | |
399 | + | 16 | |
400 | + | 17 | |
401 | + | 18 | |
402 | + | 19 | |
403 | + | 20 | |
404 | + | 21 | |
405 | + | 22 | |
406 | + | 23 | |
407 | + | 24 | |
408 | + | ||
220 | 409 | opportunity to participate in a peer-to-peer review process with a | |
221 | 410 | provider who practices in the same specialty, but not necessarily | |
222 | 411 | the same sub-specialty, and who has experience treating the same | |
223 | 412 | population as the patient on w hose behalf the request is submitted; | |
224 | - | ||
225 | - | ENR. S. B. NO. 513 Page 6 | |
226 | 413 | provided, however, if the requesting provider determin es the | |
227 | 414 | services to be clinically urgent, the contracted entity shall | |
228 | 415 | provide such opportunity within twenty-four (24) hours of receipt of | |
229 | 416 | such issuance. Services not covered under the state Medicaid | |
230 | 417 | program for the particular patient shall not be subject to peer-to- | |
231 | 418 | peer review. | |
232 | - | ||
233 | 419 | I. J. The Authority shall ensure that a provider offers to | |
234 | 420 | provide to an enrollee a member in a timely manner services | |
235 | 421 | authorized by a contracted entity. | |
236 | - | ||
237 | 422 | J. K. The Authority shall establish requirements for both | |
238 | 423 | internal and external reviews and appeals of adverse determinations | |
239 | 424 | on prior authorization requests or claims that, at a minimum: | |
240 | - | ||
241 | 425 | 1. Require contracted entities to provide a detailed | |
242 | 426 | explanation of denials to Medicaid providers and members; | |
243 | - | ||
244 | 427 | 2. Require contracted entities to provide a prompt opportunity | |
245 | 428 | for peer-to-peer conversations with licensed clinical staff of the | |
246 | 429 | same or similar specialty which shall include, but not be limited | |
247 | 430 | to, Oklahoma-licensed clinical staff upon adverse determination; and | |
248 | - | ||
249 | 431 | 3. Establish uniform rules for Medicaid provider or member | |
250 | 432 | appeals across all contracted entities. | |
433 | + | ||
434 | + | ENGR. H. A. to ENGR. S. B. NO. 513 Page 9 1 | |
435 | + | 2 | |
436 | + | 3 | |
437 | + | 4 | |
438 | + | 5 | |
439 | + | 6 | |
440 | + | 7 | |
441 | + | 8 | |
442 | + | 9 | |
443 | + | 10 | |
444 | + | 11 | |
445 | + | 12 | |
446 | + | 13 | |
447 | + | 14 | |
448 | + | 15 | |
449 | + | 16 | |
450 | + | 17 | |
451 | + | 18 | |
452 | + | 19 | |
453 | + | 20 | |
454 | + | 21 | |
455 | + | 22 | |
456 | + | 23 | |
457 | + | 24 | |
251 | 458 | ||
252 | 459 | SECTION 3. NEW LAW A new section of law to be codified | |
253 | 460 | in the Oklahoma Statutes as Section 4003 of Title 56, unless there | |
254 | 461 | is created a duplication in numb ering, reads as follows: | |
255 | - | ||
256 | 462 | A. As used in this section: | |
257 | - | ||
258 | 463 | 1. "Biomarker", "biomarker testing", "consensus statement", and | |
259 | 464 | "nationally recognized clinical practice guidelines" shall have the | |
260 | 465 | same meaning as provided by Section 1 of this act; and | |
261 | - | ||
262 | 466 | 2. "Contracted entity" shall have the same meaning as provided | |
263 | 467 | by Section 4002.2 of Title 56 of the Oklahoma Statutes. | |
264 | - | ||
265 | 468 | B. The state Medicaid program s hall cover biomarker testing in | |
266 | 469 | accordance with the requirements provided by this section. | |
267 | - | ||
268 | - | ||
269 | - | ENR. S. B. NO. 513 Page 7 | |
270 | 470 | C. Biomarker testing shall be cove red for the purposes of | |
271 | 471 | diagnosis, treatment, approp riate management, or ongoing monitoring | |
272 | 472 | of a member’s disease or condition whe n the test is supported by | |
273 | 473 | medical and scientific evidence, including, but not limited to: | |
274 | - | ||
275 | 474 | 1. Labeled indications for a United States Food and Drug | |
276 | 475 | Administration (FDA)-approved or -cleared test; | |
277 | - | ||
278 | 476 | 2. Indicated tests for an FDA-approved drug; | |
279 | - | ||
280 | 477 | 3. Warnings and precautions on FDA-approved drug labels; | |
281 | - | ||
282 | 478 | 4. Centers for Medicare and Medicaid Services (CMS) national | |
283 | 479 | coverage determinations or Medicare Administrative Contrac tor (MAC) | |
284 | 480 | local coverage determinations; or | |
285 | - | ||
286 | 481 | 5. Nationally recognized clinical pra ctice guidelines and | |
287 | 482 | consensus statements. | |
483 | + | ||
484 | + | ENGR. H. A. to ENGR. S. B. NO. 513 Page 10 1 | |
485 | + | 2 | |
486 | + | 3 | |
487 | + | 4 | |
488 | + | 5 | |
489 | + | 6 | |
490 | + | 7 | |
491 | + | 8 | |
492 | + | 9 | |
493 | + | 10 | |
494 | + | 11 | |
495 | + | 12 | |
496 | + | 13 | |
497 | + | 14 | |
498 | + | 15 | |
499 | + | 16 | |
500 | + | 17 | |
501 | + | 18 | |
502 | + | 19 | |
503 | + | 20 | |
504 | + | 21 | |
505 | + | 22 | |
506 | + | 23 | |
507 | + | 24 | |
288 | 508 | ||
289 | 509 | D. Contracted entities under the state Medicaid program shall | |
290 | 510 | provide biomarker testing at the same sc ope, duration, and frequency | |
291 | 511 | as the Medicaid program otherwise provides to members. | |
292 | - | ||
293 | 512 | E. If prior authorization is required for biomar ker testing, | |
294 | 513 | the contracted entity shall approve or deny a prior authorization | |
295 | 514 | request and notify the member, the member’s provider, and any entity | |
296 | 515 | requesting authorization of th e service within seventy-two (72) | |
297 | 516 | hours for non-urgent requests or within twenty-four (24) hours for | |
298 | 517 | urgent requests. | |
299 | - | ||
300 | 518 | F. The member and t he member’s provider shall have access to | |
301 | 519 | clear, readily access ible, and convenient process es to request an | |
302 | 520 | exception to a coverage policy for biomarker testing of the state | |
303 | 521 | Medicaid program. The process shall be made readily accessible to | |
304 | 522 | all participating providers and members online. | |
523 | + | SECTION 4. This act shall become effective January 1, 2024." | |
305 | 524 | ||
306 | - | SECTION 4. This act shall become effective January 1, 2024. | |
525 | + | ENGR. H. A. to ENGR. S. B. NO. 513 Page 11 1 | |
526 | + | 2 | |
527 | + | 3 | |
528 | + | 4 | |
529 | + | 5 | |
530 | + | 6 | |
531 | + | 7 | |
532 | + | 8 | |
533 | + | 9 | |
534 | + | 10 | |
535 | + | 11 | |
536 | + | 12 | |
537 | + | 13 | |
538 | + | 14 | |
539 | + | 15 | |
540 | + | 16 | |
541 | + | 17 | |
542 | + | 18 | |
543 | + | 19 | |
544 | + | 20 | |
545 | + | 21 | |
546 | + | 22 | |
547 | + | 23 | |
548 | + | 24 | |
549 | + | ||
550 | + | Passed the House of Representat ives the 20th day of April, 2023. | |
307 | 551 | ||
308 | 552 | ||
309 | - | ENR. S. B. NO. 513 Page 8 | |
310 | - | Passed the Senate the 19th day of May, 2023. | |
553 | + | ||
554 | + | ||
555 | + | ||
556 | + | Presiding Officer of the House of | |
557 | + | Representatives | |
558 | + | ||
559 | + | ||
560 | + | Passed the Senate the ____ day of __________, 2023. | |
561 | + | ||
562 | + | ||
311 | 563 | ||
312 | 564 | ||
313 | 565 | ||
314 | 566 | Presiding Officer of the Senate | |
315 | 567 | ||
316 | 568 | ||
317 | - | Passed the House of Representatives the 20th day of April, 2023. | |
569 | + | ENGR. S. B. NO. 513 Page 1 1 | |
570 | + | 2 | |
571 | + | 3 | |
572 | + | 4 | |
573 | + | 5 | |
574 | + | 6 | |
575 | + | 7 | |
576 | + | 8 | |
577 | + | 9 | |
578 | + | 10 | |
579 | + | 11 | |
580 | + | 12 | |
581 | + | 13 | |
582 | + | 14 | |
583 | + | 15 | |
584 | + | 16 | |
585 | + | 17 | |
586 | + | 18 | |
587 | + | 19 | |
588 | + | 20 | |
589 | + | 21 | |
590 | + | 22 | |
591 | + | 23 | |
592 | + | 24 | |
593 | + | ||
594 | + | ENGROSSED SENATE | |
595 | + | BILL NO. 513 By: Rosino and Garvin of the | |
596 | + | Senate | |
597 | + | ||
598 | + | and | |
599 | + | ||
600 | + | Miller, Fugate, and Stinson | |
601 | + | of the House | |
602 | + | ||
603 | + | ||
604 | + | ||
605 | + | ||
606 | + | An Act relating to biomarker testing; defining terms; | |
607 | + | requiring coverage of biomarker testing under certain | |
608 | + | conditions; requiring certain contract to be provided | |
609 | + | with policy; directing plan to limit disruptions in | |
610 | + | care with certain evidence; requiring plan to publish | |
611 | + | accessible process on certain website for certain | |
612 | + | requests; construing provision; amending 56 O.S. | |
613 | + | 2021, Section 4002.6, as amended by Section 10, | |
614 | + | Chapter 395, O.S.L. 2022 (56 O.S. Supp. 2022, Section | |
615 | + | 4002.6), which relates to the state Medicaid program; | |
616 | + | clarifying certain prio r authorization requirement; | |
617 | + | updating statutory language; defining terms; | |
618 | + | requiring certain coverage and provision of biomarker | |
619 | + | testing; stipulating prior au thorization requirements | |
620 | + | for biomarker testing; directing creation of process | |
621 | + | to request exceptions to certain coverage policies; | |
622 | + | providing for codification; and providing an | |
623 | + | effective date. | |
624 | + | ||
625 | + | ||
626 | + | ||
627 | + | ||
628 | + | BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA: | |
629 | + | SECTION 5. NEW LAW A new section of law to be codified | |
630 | + | in the Oklahoma Statutes as Section 6060.5a of Title 36, unless | |
631 | + | there is created a duplication in numbering, reads as follows: | |
632 | + | A. As used in this section: | |
633 | + | 1. “Biomarker” means a biological molecule found in blood, | |
634 | + | other body fluids, or tissues that is a sign of a normal or abnormal | |
635 | + | ||
636 | + | ENGR. S. B. NO. 513 Page 2 1 | |
637 | + | 2 | |
638 | + | 3 | |
639 | + | 4 | |
640 | + | 5 | |
641 | + | 6 | |
642 | + | 7 | |
643 | + | 8 | |
644 | + | 9 | |
645 | + | 10 | |
646 | + | 11 | |
647 | + | 12 | |
648 | + | 13 | |
649 | + | 14 | |
650 | + | 15 | |
651 | + | 16 | |
652 | + | 17 | |
653 | + | 18 | |
654 | + | 19 | |
655 | + | 20 | |
656 | + | 21 | |
657 | + | 22 | |
658 | + | 23 | |
659 | + | 24 | |
660 | + | ||
661 | + | process, or of a condition or disease. A biomarker may be u sed to | |
662 | + | see how well the body responds to a treatment for a disease or | |
663 | + | condition or for other purposes . Biomarkers shall include but are | |
664 | + | not limited to gene m utation or protein expression; | |
665 | + | 2. “Biomarker testing” means the analysis of a patient’s | |
666 | + | tissue, blood, or other biospecimen for the presence of a biomarker. | |
667 | + | Biomarker testing shall include but not be limited to single-analyte | |
668 | + | tests, multiplex panel tests, gene or protein expression, and whole | |
669 | + | exome, whole genome, and whole transcriptome sequencing; | |
670 | + | 3. “Consensus statement” means a statement that: | |
671 | + | a. is developed by an independent, multidisciplinary | |
672 | + | panel of experts that use a transparent methodolo gy | |
673 | + | and reporting structure that includes a conflict of | |
674 | + | interest policy, | |
675 | + | b. is based on the best available evidence for the | |
676 | + | purpose of optimizing clinical care outcomes , and | |
677 | + | c. is aimed at specific clinical circumstances; | |
678 | + | 4. “Health benefit plan” means a plan as defined pursuant to | |
679 | + | Section 6060.4 of Title 36 of the Oklahoma Statutes; and | |
680 | + | 5. “Nationally recognized clinical practice guidelines” means | |
681 | + | evidence-based clinical practice guidelines that: | |
682 | + | a. are developed by independent organizations or medical | |
683 | + | professional societies using a transparent methodology | |
684 | + | ||
685 | + | ENGR. S. B. NO. 513 Page 3 1 | |
686 | + | 2 | |
687 | + | 3 | |
688 | + | 4 | |
689 | + | 5 | |
690 | + | 6 | |
691 | + | 7 | |
692 | + | 8 | |
693 | + | 9 | |
694 | + | 10 | |
695 | + | 11 | |
696 | + | 12 | |
697 | + | 13 | |
698 | + | 14 | |
699 | + | 15 | |
700 | + | 16 | |
701 | + | 17 | |
702 | + | 18 | |
703 | + | 19 | |
704 | + | 20 | |
705 | + | 21 | |
706 | + | 22 | |
707 | + | 23 | |
708 | + | 24 | |
709 | + | ||
710 | + | and reporting structure an d a conflict of interest | |
711 | + | policy, and | |
712 | + | b. establish standards of care that are informed by a | |
713 | + | systemic review of evidence and an assessment of the | |
714 | + | benefits and costs of alternative care options that | |
715 | + | includes recommendations intended to optimize patient | |
716 | + | care. | |
717 | + | B. Any health benefit pla n, including the Okla homa Employees | |
718 | + | Insurance Plan, that is offered, issued, or renewed in this stat e on | |
719 | + | or after the effective date of this act shall provide coverage for | |
720 | + | biomarker testing. A contract provided with a health benefit plan | |
721 | + | under this section shall include bioma rker testing for the purpose | |
722 | + | of diagnosis, treatment, appropriate management, or ongoing | |
723 | + | monitoring of an insured’s disease or condition to guide treatment | |
724 | + | decisions when the biomarker test is supported by medical and | |
725 | + | scientific evidence including, but not limited to: | |
726 | + | 1. Labeled indications for tests that are approved or cleared | |
727 | + | by the United States Food and D rug Administration; | |
728 | + | 2. Indicated tests for a drug that is approved by the United | |
729 | + | States Food and Drug Administration; | |
730 | + | 3. Warnings and precautions o n United States Food and Drug | |
731 | + | Administration approved d rug labels; | |
732 | + | ||
733 | + | ENGR. S. B. NO. 513 Page 4 1 | |
734 | + | 2 | |
735 | + | 3 | |
736 | + | 4 | |
737 | + | 5 | |
738 | + | 6 | |
739 | + | 7 | |
740 | + | 8 | |
741 | + | 9 | |
742 | + | 10 | |
743 | + | 11 | |
744 | + | 12 | |
745 | + | 13 | |
746 | + | 14 | |
747 | + | 15 | |
748 | + | 16 | |
749 | + | 17 | |
750 | + | 18 | |
751 | + | 19 | |
752 | + | 20 | |
753 | + | 21 | |
754 | + | 22 | |
755 | + | 23 | |
756 | + | 24 | |
757 | + | ||
758 | + | 4. Centers for Medicare and Medicaid S ervices national coverage | |
759 | + | determinations or Medicare admini strative contractor local coverage | |
760 | + | determinations; or | |
761 | + | 5. Nationally recognized clinical pr actice guidelines and | |
762 | + | consensus statements. | |
763 | + | C. A health benefit plan shall ensure that coverage is provid ed | |
764 | + | in a manner that limits disruptions in care, including the need for | |
765 | + | multiple biopsies and biospeci men samples. | |
766 | + | D. An insured and a prescribing practitioner shall have access | |
767 | + | to a clear, readily available, and convenient proc ess to request an | |
768 | + | exception to a coverage policy of a health benefit plan under this | |
769 | + | subsection. The process shall be readily accessible on the plan’s | |
770 | + | website. This subsection shall not be construed to require a | |
771 | + | separate process if the health benefit pla n’s existing process | |
772 | + | complies with this subsection. | |
773 | + | SECTION 6. AMENDATORY 56 O.S. 2021, Section 4002.6, a s | |
774 | + | amended by Section 10, Chapter 395, O.S.L. 2022 (56 O.S. Supp. 2022, | |
775 | + | Section 4002.6), is amended to read as follows: | |
776 | + | Section 4002.6. A. A contracted entity shall meet all | |
777 | + | requirements established by the Oklah oma Health Care Authority | |
778 | + | pertaining to prior authorizations. The Authority shall establish | |
779 | + | requirements that ensure timely determinations by contracted | |
780 | + | entities when prior authorizations are required including expedited | |
781 | + | ||
782 | + | ENGR. S. B. NO. 513 Page 5 1 | |
783 | + | 2 | |
784 | + | 3 | |
785 | + | 4 | |
786 | + | 5 | |
787 | + | 6 | |
788 | + | 7 | |
789 | + | 8 | |
790 | + | 9 | |
791 | + | 10 | |
792 | + | 11 | |
793 | + | 12 | |
794 | + | 13 | |
795 | + | 14 | |
796 | + | 15 | |
797 | + | 16 | |
798 | + | 17 | |
799 | + | 18 | |
800 | + | 19 | |
801 | + | 20 | |
802 | + | 21 | |
803 | + | 22 | |
804 | + | 23 | |
805 | + | 24 | |
806 | + | ||
807 | + | review in urgent and emergent case s that at a minimum meet the | |
808 | + | criteria of this section. | |
809 | + | B. A contracted entity shall make a determination on a request | |
810 | + | for an authorization of the transfer of a hospital inpatient to a | |
811 | + | post-acute care or long-term acute care facility within twenty-four | |
812 | + | (24) hours of receipt of the request. | |
813 | + | C. A contracted entity shall make a determination on a request | |
814 | + | for any member who is not hospitalized at the time of the request | |
815 | + | within seventy-two (72) hours of receipt of the request; provided, | |
816 | + | that if the request does not include sufficient or adequate | |
817 | + | documentation, the review and determination shall occur within a | |
818 | + | time frame and in accordance with a process established by the | |
819 | + | Authority. The process established by the Authority pursuant to | |
820 | + | this subsection shall include a time frame of at least forty-eight | |
821 | + | (48) hours within which a provider may submit the necessary | |
822 | + | documentation. | |
823 | + | D. A contracted entity shall make a determination on a request | |
824 | + | for services for a hospitalized member including, but not limited | |
825 | + | to, acute care inpatient services or equipment necessary to | |
826 | + | discharge the member from an inpatient facility within one (1) | |
827 | + | business day of receipt of the request. | |
828 | + | E. Notwithstanding the provisions of subsection C of this | |
829 | + | section, a contracted entity shall make a determination on a request | |
830 | + | as expeditiously as necessary and, in any eve nt, within twenty-four | |
831 | + | ||
832 | + | ENGR. S. B. NO. 513 Page 6 1 | |
833 | + | 2 | |
834 | + | 3 | |
835 | + | 4 | |
836 | + | 5 | |
837 | + | 6 | |
838 | + | 7 | |
839 | + | 8 | |
840 | + | 9 | |
841 | + | 10 | |
842 | + | 11 | |
843 | + | 12 | |
844 | + | 13 | |
845 | + | 14 | |
846 | + | 15 | |
847 | + | 16 | |
848 | + | 17 | |
849 | + | 18 | |
850 | + | 19 | |
851 | + | 20 | |
852 | + | 21 | |
853 | + | 22 | |
854 | + | 23 | |
855 | + | 24 | |
856 | + | ||
857 | + | (24) hours of receipt of the request for service if adhering to the | |
858 | + | provisions of subsection C or D of this section could jeopardize the | |
859 | + | member’s life, health or ability to attain, maintain or regain | |
860 | + | maximum function. In the event of a medically emergent matter, the | |
861 | + | contracted entity shall not impose limitations on providers in | |
862 | + | coordination of post-emergent stabilization health care including | |
863 | + | pre-certification or prior authorization. | |
864 | + | F. Notwithstanding any other provision of this section, a | |
865 | + | contracted entity shall make a determination on a request for | |
866 | + | inpatient behavioral health s ervices within twenty-four (24) hours | |
867 | + | of receipt of the request. | |
868 | + | G. A contracted entity shall make a determination on a request | |
869 | + | for covered prescription dr ugs that are required to be prior | |
870 | + | authorized by the Authority within twenty-four (24) hours of receipt | |
871 | + | of the request. The contracted entity shall not require prior | |
872 | + | authorization on any covered prescription drug for which the | |
873 | + | Authority does not require prior authorization. | |
874 | + | H. A contracted entity shall make a determination on a re quest | |
875 | + | for coverage of biomarker testing in accordan ce with Section 3 of | |
876 | + | this act. | |
877 | + | I. Upon issuance of an adverse determination on a prior | |
878 | + | authorization request under subsection B of this section, the | |
879 | + | contracted entity shall provide the requesting provider, within | |
880 | + | seventy-two (72) hours of receipt of suc h issuance, with reasonable | |
881 | + | ||
882 | + | ENGR. S. B. NO. 513 Page 7 1 | |
883 | + | 2 | |
884 | + | 3 | |
885 | + | 4 | |
886 | + | 5 | |
887 | + | 6 | |
888 | + | 7 | |
889 | + | 8 | |
890 | + | 9 | |
891 | + | 10 | |
892 | + | 11 | |
893 | + | 12 | |
894 | + | 13 | |
895 | + | 14 | |
896 | + | 15 | |
897 | + | 16 | |
898 | + | 17 | |
899 | + | 18 | |
900 | + | 19 | |
901 | + | 20 | |
902 | + | 21 | |
903 | + | 22 | |
904 | + | 23 | |
905 | + | 24 | |
906 | + | ||
907 | + | opportunity to participate in a peer-to-peer review process with a | |
908 | + | provider who practices in the same specialty, but not necessarily | |
909 | + | the same sub-specialty, and who has experience treating the same | |
910 | + | population as the patient on w hose behalf the request is submitted; | |
911 | + | provided, however, if the requesting provider determin es the | |
912 | + | services to be clinically urgent, the contracted entity shall | |
913 | + | provide such opportunity within twenty-four (24) hours of receipt of | |
914 | + | such issuance. Services not covered under the state Medicaid | |
915 | + | program for the particular patient shall not be subject to peer-to- | |
916 | + | peer review. | |
917 | + | I. J. The Authority shall ensure that a provider offers to | |
918 | + | provide to an enrollee a member in a timely manner services | |
919 | + | authorized by a contracted entity. | |
920 | + | J. K. The Authority shall establish requirements for both | |
921 | + | internal and external reviews and appeals of adverse determinations | |
922 | + | on prior authorization requests or claims that, at a minimum: | |
923 | + | 1. Require contracted entities to provide a detailed | |
924 | + | explanation of denials to Medicaid providers and members; | |
925 | + | 2. Require contracted entities to provide a prompt opportunity | |
926 | + | for peer-to-peer conversations with licensed clinical staff of the | |
927 | + | same or similar specialty which shall include, but not be limited | |
928 | + | to, Oklahoma-licensed clinical staff upon adverse determination; and | |
929 | + | 3. Establish uniform rules for Medicaid provider or member | |
930 | + | appeals across all contracted entities. | |
931 | + | ||
932 | + | ENGR. S. B. NO. 513 Page 8 1 | |
933 | + | 2 | |
934 | + | 3 | |
935 | + | 4 | |
936 | + | 5 | |
937 | + | 6 | |
938 | + | 7 | |
939 | + | 8 | |
940 | + | 9 | |
941 | + | 10 | |
942 | + | 11 | |
943 | + | 12 | |
944 | + | 13 | |
945 | + | 14 | |
946 | + | 15 | |
947 | + | 16 | |
948 | + | 17 | |
949 | + | 18 | |
950 | + | 19 | |
951 | + | 20 | |
952 | + | 21 | |
953 | + | 22 | |
954 | + | 23 | |
955 | + | 24 | |
956 | + | ||
957 | + | SECTION 7. NEW LAW A new section of law to be codified | |
958 | + | in the Oklahoma Statutes as Se ction 4003 of Title 56, unless there | |
959 | + | is created a duplication in numb ering, reads as follows: | |
960 | + | A. As used in this section: | |
961 | + | 1. “Biomarker”, “biomarker testing”, “consensus statement”, and | |
962 | + | “nationally recognized clinical practice guidelines” shall have the | |
963 | + | same meaning as provided by Section 1 of this act; and | |
964 | + | 2. “Contracted entity” shall have the same meaning as provided | |
965 | + | by Section 4002.2 of Title 56 of the Oklahoma Statutes. | |
966 | + | B. The state Medicaid program s hall cover biomarker testing in | |
967 | + | accordance with the requirements p rovided by this secti on. | |
968 | + | C. Biomarker testing shall be cove red for the purposes of | |
969 | + | diagnosis, treatment, approp riate management, or ongoing monitoring | |
970 | + | of a member’s disease or condition whe n the test is supported by | |
971 | + | medical and scientific evidence, includ ing, but not limited to: | |
972 | + | 1. Labeled indications for a Food and Drug Administration | |
973 | + | (FDA)-approved or -cleared test; | |
974 | + | 2. Indicated tests for an FDA-approved drug; | |
975 | + | 3. Warnings and precautions on FDA-approved drug labels; | |
976 | + | 4. Centers for Medicare and Medicaid Services (CMS) national | |
977 | + | coverage determinations or Medicare Administrative Contractor (MAC) | |
978 | + | local coverage determinations; or | |
979 | + | 5. Nationally recognized clinical pra ctice guidelines and | |
980 | + | consensus statements. | |
981 | + | ||
982 | + | ENGR. S. B. NO. 513 Page 9 1 | |
983 | + | 2 | |
984 | + | 3 | |
985 | + | 4 | |
986 | + | 5 | |
987 | + | 6 | |
988 | + | 7 | |
989 | + | 8 | |
990 | + | 9 | |
991 | + | 10 | |
992 | + | 11 | |
993 | + | 12 | |
994 | + | 13 | |
995 | + | 14 | |
996 | + | 15 | |
997 | + | 16 | |
998 | + | 17 | |
999 | + | 18 | |
1000 | + | 19 | |
1001 | + | 20 | |
1002 | + | 21 | |
1003 | + | 22 | |
1004 | + | 23 | |
1005 | + | 24 | |
1006 | + | ||
1007 | + | D. Contracted entities under the sta te Medicaid program shall | |
1008 | + | provide biomarker testing at the same scope, dur ation, and frequency | |
1009 | + | as the Medicaid program otherwise provides to members. | |
1010 | + | E. If prior authorization is required for biomar ker testing, | |
1011 | + | the contracted entity shall approve or deny a prior authorization | |
1012 | + | request and notify the member, the member’s provider, and any entity | |
1013 | + | requesting authorization of th e service within seventy-two (72) | |
1014 | + | hours for non-urgent requests or within twenty-four (24) hours for | |
1015 | + | urgent requests. | |
1016 | + | F. The member and the mem ber’s provider shall have access to | |
1017 | + | clear, readily accessible, an d convenient processes to request an | |
1018 | + | exception to a coverage policy for biomarker testing of the state | |
1019 | + | Medicaid program. The process shall be made readily accessible to | |
1020 | + | all participating providers and members on line. | |
1021 | + | SECTION 8. This act shall become effective January 1, 2024. | |
1022 | + | ||
1023 | + | ENGR. S. B. NO. 513 Page 10 1 | |
1024 | + | 2 | |
1025 | + | 3 | |
1026 | + | 4 | |
1027 | + | 5 | |
1028 | + | 6 | |
1029 | + | 7 | |
1030 | + | 8 | |
1031 | + | 9 | |
1032 | + | 10 | |
1033 | + | 11 | |
1034 | + | 12 | |
1035 | + | 13 | |
1036 | + | 14 | |
1037 | + | 15 | |
1038 | + | 16 | |
1039 | + | 17 | |
1040 | + | 18 | |
1041 | + | 19 | |
1042 | + | 20 | |
1043 | + | 21 | |
1044 | + | 22 | |
1045 | + | 23 | |
1046 | + | 24 | |
1047 | + | ||
1048 | + | Passed the Senate the 6th day of March, 2023. | |
1049 | + | ||
1050 | + | ||
1051 | + | ||
1052 | + | Presiding Officer of the Senate | |
1053 | + | ||
1054 | + | ||
1055 | + | Passed the House of Representatives the ____ day of __________, | |
1056 | + | 2023. | |
318 | 1057 | ||
319 | 1058 | ||
320 | 1059 | ||
321 | 1060 | Presiding Officer of the House | |
322 | 1061 | of Representatives | |
323 | 1062 | ||
324 | - | OFFICE OF THE GOVERNOR | |
325 | - | Received by the Office of the Governor this _______ _____________ | |
326 | - | day of _________________ __, 20_______, at _______ o'clock ____ ___ M. | |
327 | - | By: _______________________________ __ | |
328 | - | Approved by the Governor of the State of Oklahoma this _____ ____ | |
329 | - | day of ___________________, 20_______, at _______ o'clock _______ M. | |
330 | 1063 | ||
331 | - | _________________________________ | |
332 | - | Governor of the State of Oklahoma | |
333 | - | ||
334 | - | ||
335 | - | OFFICE OF THE SECRETARY OF STATE | |
336 | - | Received by the Office of the Secretary of State this _______ ___ | |
337 | - | day of __________________, 20 _______, at _______ o'clock _______ M. | |
338 | - | By: _______________________________ __ |