Bill Text: FL S0528 | 2021 | Regular Session | Introduced
Bill Title: Health Insurance Prior Authorization
Spectrum: Partisan Bill (Republican 1-0)
Status: (Failed) 2021-04-30 - Died in Banking and Insurance [S0528 Detail]
Download: Florida-2021-S0528-Introduced.html
Florida Senate - 2021 SB 528 By Senator Harrell 25-00636-21 2021528__ 1 A bill to be entitled 2 An act relating to health insurance prior 3 authorization; amending s. 627.4239, F.S.; defining 4 the terms “associated condition” and “health care 5 provider”; prohibiting health maintenance 6 organizations from excluding coverage for certain 7 cancer treatment drugs; prohibiting health insurers 8 and health maintenance organizations from requiring, 9 before providing prescription drug coverage for the 10 treatment of stage 4 metastatic cancer and associated 11 conditions, that treatment has failed with a different 12 drug; providing applicability; prohibiting insurers 13 and health maintenance organizations from excluding 14 coverage for certain drugs on certain grounds; 15 revising construction; amending s. 627.42392, F.S.; 16 revising the definition of the term “health insurer”; 17 defining the term “urgent care situation”; specifying 18 a requirement for the prior authorization form adopted 19 by the Financial Services Commission by rule; 20 authorizing the commission to adopt certain rules; 21 specifying requirements for, and restrictions on, 22 health insurers and pharmacy benefits managers 23 relating to prior authorization information, 24 requirements, restrictions, and changes; providing 25 applicability; specifying timeframes in which prior 26 authorization requests must be authorized or denied 27 and the patient and the patient’s provider must be 28 notified; amending s. 627.42393, F.S.; defining terms; 29 requiring health insurers to provide and disclose 30 procedures for insureds to request exceptions to step 31 therapy protocols; specifying requirements for such 32 procedures and disclosures; requiring health insurers 33 to authorize or deny protocol exception requests and 34 respond to certain appeals within specified 35 timeframes; specifying required information in 36 authorizations and denials of such requests; requiring 37 health insurers to grant a protocol exception request 38 under specified circumstances; authorizing health 39 insurers to request certain documentation; conforming 40 provisions to changes made by the act; amending s. 41 627.6131, F.S.; prohibiting health insurers, under 42 certain circumstances, from retroactively denying a 43 claim at any time because of insured ineligibility; 44 prohibiting health insurers from imposing an 45 additional prior authorization requirement with 46 respect to certain surgical or invasive procedures or 47 certain items; amending s. 641.31, F.S.; defining 48 terms; requiring health maintenance organizations to 49 provide and disclose procedures for subscribers to 50 request exceptions to step-therapy protocols; 51 specifying requirements for such procedures and 52 disclosures; requiring health maintenance 53 organizations to authorize or deny protocol exception 54 requests and respond to certain appeals within 55 specified timeframes; specifying required information 56 in authorizations and denials of such requests; 57 requiring health maintenance organizations to grant a 58 protocol exception request under specified 59 circumstances; authorizing health maintenance 60 organizations to request certain documentation; 61 conforming provisions to changes made by the act; 62 amending s. 641.3155, F.S.; prohibiting health 63 maintenance organizations, under certain 64 circumstances, from retroactively denying a claim at 65 any time because of subscriber ineligibility; amending 66 s. 641.3156, F.S.; prohibiting health maintenance 67 organizations from imposing an additional prior 68 authorization requirement with respect to certain 69 surgical or invasive procedures or certain items; 70 providing an effective date. 71 72 Be It Enacted by the Legislature of the State of Florida: 73 74 Section 1. Section 627.4239, Florida Statutes, is amended 75 to read: 76 627.4239 Coverage for use of drugs in treatment of cancer.— 77 (1) DEFINITIONS.—As used in this section, the term: 78 (a) “Associated condition” means a symptom or side effect 79 that: 80 1. Is associated with a particular cancer at a particular 81 stage or with the treatment of that cancer; and 82 2. In the judgment of a health care provider, will further 83 jeopardize the health of a patient if left untreated. As used in 84 this subparagraph, the term “health care provider” means a 85 physician licensed under chapter 458, chapter 459, or chapter 86 461, a physician assistant licensed under chapter 458 or chapter 87 459, an advanced practice registered nurse licensed under 88 chapter 464, or a dentist licensed under chapter 466. 89 (b) “Medical literature” means scientific studies published 90 in a United States peer-reviewed national professional journal. 91 (c)(b)“Standard reference compendium” means authoritative 92 compendia identified by the Secretary of the United States 93 Department of Health and Human Services and recognized by the 94 federal Centers for Medicare and Medicaid Services. 95 (2) COVERAGE FOR TREATMENT OF CANCER.— 96(a)An insurer or a health maintenance organization may not 97 exclude coverage in any individual or group health insurance 98 policy or health maintenance contract issued, amended, 99 delivered, or renewed in this state which covers the treatment 100 of cancer for any drug prescribed for the treatment of cancer on 101 the ground that the drug is not approved by the United States 102 Food and Drug Administration for a particular indication, if 103 that drug is recognized for treatment of that indication in a 104 standard reference compendium or recommended in the medical 105 literature. 106(b)Coverage for a drug required by this section also107includes the medically necessary services associated with the108administration of the drug.109 (3) COVERAGE FOR TREATMENT OF STAGE 4 METASTATIC CANCER AND 110 ASSOCIATED CONDITIONS.— 111 (a) An insurer or a health maintenance organization may not 112 require in any individual or group health insurance policy or 113 health maintenance contract issued, amended, delivered, or 114 renewed in this state which covers the treatment of stage 4 115 metastatic cancer and its associated conditions that, before a 116 drug prescribed for the treatment is covered, the insured or 117 subscriber fail or have previously failed to respond 118 successfully to a different drug. 119 (b) Paragraph (a) applies to a drug that is recognized for 120 the treatment of such stage 4 metastatic cancer or its 121 associated conditions, as applicable, in a standard reference 122 compendium or that is recommended in the medical literature. The 123 insurer or health maintenance organization may not exclude 124 coverage for such drug on the ground that the drug is not 125 approved by the United States Food and Drug Administration for 126 such stage 4 metastatic cancer or its associated conditions, as 127 applicable. 128 (4) COVERAGE FOR SERVICES ASSOCIATED WITH DRUG 129 ADMINISTRATION.—Coverage for a drug required by this section 130 also includes the medically necessary services associated with 131 the administration of the drug. 132 (5)(3)APPLICABILITY AND SCOPE.—This section may not be 133 construed to: 134 (a) Alter any other law with regard to provisions limiting 135 coverage for drugs that are not approved by the United States 136 Food and Drug Administration, except for drugs for the treatment 137 of stage 4 metastatic cancer or its associated conditions. 138 (b) Require coverage for any drug, except for a drug for 139 the treatment of stage 4 metastatic cancer or its associated 140 conditions, if the United States Food and Drug Administration 141 has determined that the use of the drug is contraindicated. 142 (c) Require coverage for a drug that is not otherwise 143 approved for any indication by the United States Food and Drug 144 Administration, except for a drug for the treatment of stage 4 145 metastatic cancer or its associated conditions. 146 (d) Affect the determination as to whether particular 147 levels, dosages, or usage of a medication associated with bone 148 marrow transplant procedures are covered under an individual or 149 group health insurance policy or health maintenance organization 150 contract. 151 (e) Apply to specified disease or supplemental policies. 152 (f)(4)Nothing in this section is intended,Expressly or by 153 implication,tocreate, impair, alter, limit, modify, enlarge, 154 abrogate, prohibit, or withdraw any authority to provide 155 reimbursement for drugs used in the treatment of any other 156 disease or condition. 157 Section 2. Section 627.42392, Florida Statutes, is amended 158 to read: 159 627.42392 Prior authorization.— 160 (1) As used in this section, the term: 161 (a) “Health insurer” means an authorized insurer offering 162 an individual or group health insurance policy that provides 163 major medical or similar comprehensive coveragehealth insurance164as defined in s. 624.603, a managed care plan as defined in s. 165 409.962(10), or a health maintenance organization as defined in 166 s. 641.19(12). 167 (b) “Urgent care situation” has the same meaning as 168 provided in s. 627.42393(1). 169 (2) Notwithstanding any otherprovision oflaw, effective 170 January 1, 2017, or six (6) months after the effective date of 171 the rule adopting the prior authorization form, whichever is 172 later, a health insurer, or a pharmacy benefits manager on 173 behalf of the health insurer, which does not provide an 174 electronic prior authorization process for use by its contracted 175 providers, shall only use the prior authorization form that has 176 been approved by the Financial Services Commission for granting 177 a prior authorization for a medical procedure, course of 178 treatment, or prescription drug benefit. Such form may not 179 exceed two pages in length, excluding any instructions or 180 guiding documentation, and must include all clinical 181 documentation necessary for the health insurer to make a 182 decision. At a minimum, the form must include: 183 (a)(1)Sufficient patient information to identify the 184 member, his or her date of birth, full name, and Health Plan ID 185 number; 186 (b)(2)The provider’sprovidername, address, and phone 187 number; 188 (c)(3)The medical procedure, course of treatment, or 189 prescription drug benefit being requested, including the medical 190 reason therefor, and all services tried and failed; 191 (d)(4)Any laboratory documentation required; and 192 (e)(5)An attestation that all information provided is true 193 and accurate. 194 195 The form, whether in electronic or paper format, must require 196 only information that is necessary for the determination of 197 medical necessity of, or coverage for, the requested medical 198 procedure, course of treatment, or prescription drug benefit. 199 The commission may adopt rules prescribing such necessary 200 information. 201 (3) The Financial Services Commission, in consultation with 202 the Agency for Health Care Administration, shall adopt by rule 203 guidelines for all prior authorization forms which ensure the 204 general uniformity of such forms. 205 (4) Electronic prior authorization approvals do not 206 preclude benefit verification or medical review by the insurer 207 under either the medical or pharmacy benefits. 208 (5) A health insurer, or a pharmacy benefits manager on 209 behalf of the health insurer, shall provide upon request the 210 following information in writing or in an electronic format and 211 publish it on a publicly accessible website: 212 (a) Detailed descriptions in clear, easily understandable 213 language of the requirements for, and restrictions on, obtaining 214 prior authorization for coverage of a medical procedure, course 215 of treatment, or prescription drug. Clinical criteria must be 216 described in language a health care provider can easily 217 understand. 218 (b) Prior authorization forms. 219 (6) A health insurer, or a pharmacy benefits manager on 220 behalf of the health insurer, may not implement any new 221 requirements or restrictions or make changes to existing 222 requirements or restrictions on obtaining prior authorization 223 unless: 224 (a) The changes have been available on a publicly 225 accessible website for at least 60 days before they are 226 implemented; and 227 (b) Policyholders and health care providers who are 228 affected by the new requirements and restrictions or changes to 229 the requirements and restrictions are provided with a written 230 notice of the changes at least 60 days before they are 231 implemented. Such notice may be delivered electronically or by 232 other means as agreed to by the insured or the health care 233 provider. 234 235 This subsection does not apply to the expansion of health care 236 services coverage. 237 (7) A health insurer, or a pharmacy benefits manager on 238 behalf of the health insurer, must authorize or deny a prior 239 authorization request and notify the patient and the patient’s 240 treating health care provider of the decision within: 241 (a) Seventy-two hours after receiving a completed prior 242 authorization form for nonurgent care situations. 243 (b) Twenty-four hours after receiving a completed prior 244 authorization form for urgent care situations. 245 Section 3. Section 627.42393, Florida Statutes, is amended 246 to read: 247 627.42393 Step-therapy protocol restrictions and 248 exceptions.— 249 (1) DEFINITIONS.—As used in this section, the term: 250 (a) “Health coverage plan” means any of the following which 251 is currently or was previously providing major medical or 252 similar comprehensive coverage or benefits to the insured: 253 1. A health insurer or health maintenance organization. 254 2. A plan established or maintained by an individual 255 employer as provided by the Employee Retirement Income Security 256 Act of 1974, Pub. L. No. 93-406. 257 3. A multiple-employer welfare arrangement as defined in s. 258 624.437. 259 4. A governmental entity providing a plan of self 260 insurance. 261 (b) “Health insurer” has the same meaning as provided in s. 262 627.42392. 263 (c) “Preceding prescription drug or medical treatment” 264 means a prescription drug, medical procedure, or course of 265 treatment that must be used pursuant to a health insurer’s step 266 therapy protocol as a condition of coverage under a health 267 insurance policy to treat an insured’s condition. 268 (d) “Protocol exception” means a determination by a health 269 insurer that a step-therapy protocol is not medically 270 appropriate or indicated for treatment of an insured’s 271 condition, and the health insurer authorizes the use of another 272 medical procedure, course of treatment, or prescription drug 273 prescribed or recommended by the treating health care provider 274 for the insured’s condition. 275 (e) “Step-therapy protocol” means a written protocol that 276 specifies the order in which certain medical procedures, courses 277 of treatment, or prescription drugs must be used to treat an 278 insured’s condition. 279 (f) “Urgent care situation” means an injury or condition of 280 an insured which, if medical care and treatment are not provided 281 earlier than the time the medical profession generally considers 282 reasonable for a nonurgent situation, in the opinion of the 283 insured’s treating physician, physician assistant, or advanced 284 practice registered nurse, would: 285 1. Seriously jeopardize the insured’s life, health, or 286 ability to regain maximum function; or 287 2. Subject the insured to severe pain that cannot be 288 adequately managed. 289 (2) STEP-THERAPY PROTOCOL RESTRICTIONS.—In addition to 290 protocol exceptions granted under subsection (3) and the 291 restriction under s. 627.4239(3), a health insurer issuing a 292 major medical individual or group policy may not require a step 293 therapy protocol under the policy for a covered prescription 294 drug requested by an insured if: 295 (a) The insured has previously been approved to receive the 296 prescription drug through the completion of a step-therapy 297 protocol required by a separate health coverage plan; and 298 (b) The insured provides documentation originating from the 299 health coverage plan that approved the prescription drug as 300 described in paragraph (a) indicating that the health coverage 301 plan paid for the drug on the insured’s behalf during the 90 302 days immediately before the request. 303 (3) STEP-THERAPY PROTOCOL EXCEPTIONS; REQUIREMENTS AND 304 PROCEDURES.— 305 (a) A health insurer shall publish on its website and 306 provide to an insured in writing a procedure for the insured and 307 his or her health care provider to request a protocol exception. 308 The procedure must include: 309 1. The manner in which an insured or health care provider 310 may request a protocol exception. 311 2. The manner and timeframe in which the health insurer is 312 required to authorize or deny a protocol exception request or to 313 respond to an appeal of the health insurer’s authorization or 314 denial of a request. 315 3. The conditions under which the protocol exception 316 request must be granted. 317 (b)1. A health insurer must authorize or deny a protocol 318 exception request or respond to an appeal of a health insurer’s 319 authorization or denial of a request within: 320 a. Seventy-two hours after receiving a completed prior 321 authorization form for nonurgent care situations. 322 b. Twenty-four hours after receiving a completed prior 323 authorization form for urgent care situations. 324 2. An authorization of the request must specify the 325 approved medical procedure, course of treatment, or prescription 326 drug benefits. 327 3. A denial of the request must include a detailed written 328 explanation of the reason for the denial, the clinical rationale 329 that supports the denial, and the procedure for appealing the 330 health insurer’s determination. 331 (c) A health insurer must grant a protocol exception 332 request if any of the following applies: 333 1. A preceding prescription drug or medical treatment is 334 contraindicated or will likely cause an adverse reaction or 335 physical or mental harm to the insured. 336 2. A preceding prescription drug or medical treatment is 337 expected to be ineffective based on the insured’s medical 338 history and the clinical evidence of the characteristics of the 339 preceding prescription drug or medical treatment. 340 3. The insured has previously received a preceding 341 prescription drug or medical treatment that is in the same 342 pharmacologic class or has the same mechanism of action and such 343 drug or treatment lacked efficacy or effectiveness or adversely 344 affected the insured. 345 4. A preceding prescription drug or medical treatment is 346 not in the insured’s best interest because his or her use of the 347 drug or treatment is expected to: 348 a. Cause a significant barrier to the insured’s adherence 349 to or compliance with his or her plan of care; 350 b. Worsen the insured’s medical condition that exists 351 simultaneously with, but independently of, the condition under 352 treatment; or 353 c. Decrease the insured’s ability to achieve or maintain 354 his or her ability to perform daily activities. 355 5. A preceding prescription drug is an opioid and the 356 protocol exception request is for a nonopioid prescription drug 357 or treatment with a likelihood of similar or better results. 358 (d) A health insurer may request a copy of relevant 359 documentation from an insured’s medical record in support of a 360 protocol exception request 361(2) As used in this section, the term “health coverage362plan” means any of the following which is currently or was363previously providing major medical or similar comprehensive364coverage or benefits to the insured:365(a) A health insurer or health maintenance organization.366(b) A plan established or maintained by an individual367employer as provided by the Employee Retirement Income Security368Act of 1974, Pub. L. No. 93-406.369(c) A multiple-employer welfare arrangement as defined in370s. 624.437.371(d) A governmental entity providing a plan of self372insurance. 373 (4)(3)CONSTRUCTION.—This section does not require a health 374 insurer to add a drug to its prescription drug formulary or to 375 cover a prescription drug that the insurer does not otherwise 376 cover. 377 Section 4. Subsection (11) of section 627.6131, Florida 378 Statutes, is amended, and subsection (20) is added to that 379 section, to read: 380 627.6131 Payment of claims.— 381 (11) A health insurer may not retroactively deny a claim 382 because of insured ineligibility: 383 (a) More than 1 year after the date of payment of the 384 claim; or 385 (b) At any time, if the health insurer verified the 386 insured’s eligibility at the time of treatment or provided an 387 authorization number. 388 (20) A health insurer may not impose an additional prior 389 authorization requirement with respect to a surgical or 390 otherwise invasive procedure, or any item furnished as part of 391 the surgical or invasive procedure, if the procedure or item is 392 furnished during the perioperative period of another procedure 393 for which prior authorization was granted by the health insurer. 394 Section 5. Subsection (46) of section 641.31, Florida 395 Statutes, is amended to read: 396 641.31 Health maintenance contracts.— 397 (46)(a) Definitions.—As used in this subsection, the term: 398 1. “Health coverage plan” means any of the following which 399 is currently or was previously providing major medical or 400 similar comprehensive coverage or benefits to the subscriber: 401 a. A health insurer or health maintenance organization. 402 b. A plan established or maintained by an individual 403 employer as provided by the Employee Retirement Income Security 404 Act of 1974, Pub. L. No. 93-406. 405 c. A multiple-employer welfare arrangement as defined in s. 406 624.437. 407 d. A governmental entity providing a plan of self 408 insurance. 409 2. “Preceding prescription drug or medical treatment” means 410 a prescription drug, medical procedure, or course of treatment 411 that must be used pursuant to a health maintenance 412 organization’s step-therapy protocol as a condition of coverage 413 under a health maintenance contract to treat a subscriber’s 414 condition. 415 3. “Protocol exception” means a determination by a health 416 maintenance organization that a step-therapy protocol is not 417 medically appropriate or indicated for treatment of a 418 subscriber’s condition, and the health maintenance organization 419 authorizes the use of another medical procedure, course of 420 treatment, or prescription drug prescribed or recommended by the 421 treating health care provider for the subscriber’s condition. 422 4. “Step-therapy protocol” means a written protocol that 423 specifies the order in which certain medical procedures, courses 424 of treatment, or prescription drugs must be used to treat a 425 subscriber’s condition. 426 5. “Urgent care situation” means an injury or condition of 427 a subscriber which, if medical care and treatment are not 428 provided earlier than the time the medical profession generally 429 considers reasonable for a nonurgent situation, in the opinion 430 of the subscriber’s treating physician, physician assistant, or 431 advanced practice registered nurse, would: 432 a. Seriously jeopardize the subscriber’s life, health, or 433 ability to regain maximum function; or 434 b. Subject the subscriber to severe pain that cannot be 435 adequately managed. 436 (b) Step-therapy protocol restrictions.—In addition to 437 protocol exceptions granted under paragraph (c) and the 438 restriction under s. 627.4239(3), a health maintenance 439 organization issuing major medical coverage through an 440 individual or group contract may not require a step-therapy 441 protocol under the contract for a covered prescription drug 442 requested by a subscriber if: 443 1. The subscriber has previously been approved to receive 444 the prescription drug through the completion of a step-therapy 445 protocol required by a separate health coverage plan; and 446 2. The subscriber provides documentation originating from 447 the health coverage plan that approved the prescription drug as 448 described in subparagraph 1. indicating that the health coverage 449 plan paid for the drug on the subscriber’s behalf during the 90 450 days immediately before the request. 451 (c) Step-therapy protocol exceptions; requirements and 452 procedures.— 453 1. A health maintenance organization shall publish on its 454 website and provide to a subscriber in writing a procedure for 455 the subscriber and his or her health care provider to request a 456 protocol exception. The procedure must include: 457 a. The manner in which a subscriber or health care provider 458 may request a protocol exception. 459 b. The manner and timeframe in which the health maintenance 460 organization is required to authorize or deny a protocol 461 exception request or to respond to an appeal of the health 462 maintenance organization’s authorization or denial of a request. 463 c. The conditions under which the protocol exception 464 request must be granted. 465 2.a. A health maintenance organization must authorize or 466 deny a protocol exception request or respond to an appeal of a 467 health maintenance organization’s authorization or denial of a 468 request within: 469 (I) Seventy-two hours after receiving a completed prior 470 authorization form for nonurgent care situations. 471 (II) Twenty-four hours after receiving a completed prior 472 authorization form for urgent care situations. 473 b. An authorization of the request must specify the 474 approved medical procedure, course of treatment, or prescription 475 drug benefits. 476 c. A denial of the request must include a detailed written 477 explanation of the reason for the denial, the clinical rationale 478 that supports the denial, and the procedure for appealing the 479 health maintenance organization’s determination. 480 3. A health maintenance organization must grant a protocol 481 exception request if any of the following applies: 482 a. A preceding prescription drug or medical treatment is 483 contraindicated or will likely cause an adverse reaction or 484 physical or mental harm to the subscriber. 485 b. A preceding prescription drug or medical treatment is 486 expected to be ineffective based on the subscriber’s medical 487 history and the clinical evidence of the characteristics of the 488 preceding prescription drug or medical treatment. 489 c. The subscriber has previously received a preceding 490 prescription drug or medical treatment that is in the same 491 pharmacologic class or has the same mechanism of action and such 492 drug or treatment lacked efficacy or effectiveness or adversely 493 affected the subscriber. 494 d. A preceding prescription drug or medical treatment is 495 not in the subscriber’s best interest because his or her use of 496 the drug or treatment is expected to: 497 (I) Cause a significant barrier to the subscriber’s 498 adherence to or compliance with his or her plan of care; 499 (II) Worsen the subscriber’s medical condition that exists 500 simultaneously with, but independently of, the condition under 501 treatment; or 502 (III) Decrease the subscriber’s ability to achieve or 503 maintain his or her ability to perform daily activities. 504 e. A preceding prescription drug is an opioid and the 505 protocol exception request is for a nonopioid prescription drug 506 or treatment with a likelihood of similar or better results. 507 4. A health maintenance organization may request a copy of 508 relevant documentation from a subscriber’s medical record in 509 support of a protocol exception request 510(b) As used in this subsection, the term “health coverage511plan” means any of the following which previously provided or is512currently providing major medical or similar comprehensive513coverage or benefits to the subscriber:5141. A health insurer or health maintenance organization;5152. A plan established or maintained by an individual516employer as provided by the Employee Retirement Income Security517Act of 1974, Pub. L. No. 93-406;5183. A multiple-employer welfare arrangement as defined in s.519624.437; or5204. A governmental entity providing a plan of self521insurance. 522 (d)(c)Construction.—This subsection does not require a 523 health maintenance organization to add a drug to its 524 prescription drug formulary or to cover a prescription drug that 525 the health maintenance organization does not otherwise cover. 526 Section 6. Subsection (10) of section 641.3155, Florida 527 Statutes, is amended to read: 528 641.3155 Prompt payment of claims.— 529 (10) A health maintenance organization may not 530 retroactively deny a claim because of subscriber ineligibility: 531 (a) More than 1 year after the date of payment of the 532 claim; or 533 (b) At any time, if the health maintenance organization 534 verified the subscriber’s eligibility at the time of treatment 535 or provided an authorization number. 536 Section 7. Subsection (4) is added to section 641.3156, 537 Florida Statutes, to read: 538 641.3156 Treatment authorization; payment of claims.— 539 (4) A health maintenance organization may not impose an 540 additional prior authorization requirement with respect to a 541 surgical or otherwise invasive procedure, or any item furnished 542 as part of the surgical or invasive procedure, if the procedure 543 or item is furnished during the perioperative period of another 544 procedure for which prior authorization was granted by the 545 health maintenance organization. 546 Section 8. This act shall take effect January 1, 2022.