Florida Senate - 2020 SB 820
By Senator Harrell
25-00241C-20 2020820__
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)(a) “Medical literature” means scientific studies
90 published in a United States peer-reviewed national professional
91 journal.
92 (c)(b) “Standard reference compendium” means authoritative
93 compendia identified by the Secretary of the United States
94 Department of Health and Human Services and recognized by the
95 federal Centers for Medicare and Medicaid Services.
96 (2) COVERAGE FOR TREATMENT OF CANCER.—
97 (a) An insurer or a health maintenance organization may not
98 exclude coverage in any individual or group health insurance
99 policy or health maintenance contract issued, amended,
100 delivered, or renewed in this state which covers the treatment
101 of cancer for any drug prescribed for the treatment of cancer on
102 the ground that the drug is not approved by the United States
103 Food and Drug Administration for a particular indication, if
104 that drug is recognized for treatment of that indication in a
105 standard reference compendium or recommended in the medical
106 literature.
107 (b) Coverage for a drug required by this section also
108 includes the medically necessary services associated with the
109 administration of the drug.
110 (3) COVERAGE FOR TREATMENT OF STAGE 4 METASTATIC CANCER AND
111 ASSOCIATED CONDITIONS.—
112 (a) An insurer or a health maintenance organization may not
113 require in any individual or group health insurance policy or
114 health maintenance contract issued, amended, delivered, or
115 renewed in this state which covers the treatment of stage 4
116 metastatic cancer and its associated conditions that, before a
117 drug prescribed for the treatment is covered, the insured or
118 subscriber fail or have previously failed to respond
119 successfully to a different drug.
120 (b) Paragraph (a) applies to a drug that is recognized for
121 the treatment of such stage 4 metastatic cancer or its
122 associated conditions, as applicable, in a standard reference
123 compendium or that is recommended in the medical literature. The
124 insurer or health maintenance organization may not exclude
125 coverage for such drug on the ground that the drug is not
126 approved by the United States Food and Drug Administration for
127 such stage 4 metastatic cancer or its associated conditions, as
128 applicable.
129 (4) COVERAGE FOR SERVICES ASSOCIATED WITH DRUG
130 ADMINISTRATION.—Coverage for a drug required by this section
131 also includes the medically necessary services associated with
132 the administration of the drug.
133 (5)(3) APPLICABILITY AND SCOPE.—This section may not be
134 construed to:
135 (a) Alter any other law with regard to provisions limiting
136 coverage for drugs that are not approved by the United States
137 Food and Drug Administration, except for drugs for the treatment
138 of stage 4 metastatic cancer or its associated conditions.
139 (b) Require coverage for any drug, except for a drug for
140 the treatment of stage 4 metastatic cancer or its associated
141 conditions, if the United States Food and Drug Administration
142 has determined that the use of the drug is contraindicated.
143 (c) Require coverage for a drug that is not otherwise
144 approved for any indication by the United States Food and Drug
145 Administration, except for a drug for the treatment of stage 4
146 metastatic cancer or its associated conditions.
147 (d) Affect the determination as to whether particular
148 levels, dosages, or usage of a medication associated with bone
149 marrow transplant procedures are covered under an individual or
150 group health insurance policy or health maintenance organization
151 contract.
152 (e) Apply to specified disease or supplemental policies.
153 (f)(4) Nothing in this section is intended, Expressly or by
154 implication, to create, impair, alter, limit, modify, enlarge,
155 abrogate, prohibit, or withdraw any authority to provide
156 reimbursement for drugs used in the treatment of any other
157 disease or condition.
158 Section 2. Section 627.42392, Florida Statutes, is amended
159 to read:
160 627.42392 Prior authorization.—
161 (1) As used in this section, the term:
162 (a) “Health insurer” means an authorized insurer offering
163 an individual or group health insurance policy that provides
164 major medical or similar comprehensive coverage health insurance
165 as defined in s. 624.603, a managed care plan as defined in s.
166 409.962(10), or a health maintenance organization as defined in
167 s. 641.19(12).
168 (b) “Urgent care situation” has the same meaning as
169 provided in s. 627.42393(1).
170 (2) Notwithstanding any other provision of law, effective
171 January 1, 2017, or six (6) months after the effective date of
172 the rule adopting the prior authorization form, whichever is
173 later, a health insurer, or a pharmacy benefits manager on
174 behalf of the health insurer, which does not provide an
175 electronic prior authorization process for use by its contracted
176 providers, shall only use the prior authorization form that has
177 been approved by the Financial Services Commission for granting
178 a prior authorization for a medical procedure, course of
179 treatment, or prescription drug benefit. Such form may not
180 exceed two pages in length, excluding any instructions or
181 guiding documentation, and must include all clinical
182 documentation necessary for the health insurer to make a
183 decision. At a minimum, the form must include:
184 (a)(1) Sufficient patient information to identify the
185 member, his or her date of birth, full name, and Health Plan ID
186 number;
187 (b)(2) The provider’s provider name, address, and phone
188 number;
189 (c)(3) The medical procedure, course of treatment, or
190 prescription drug benefit being requested, including the medical
191 reason therefor, and all services tried and failed;
192 (d)(4) Any laboratory documentation required; and
193 (e)(5) An attestation that all information provided is true
194 and accurate.
195
196 The form, whether in electronic or paper format, must require
197 only information that is necessary for the determination of
198 medical necessity of, or coverage for, the requested medical
199 procedure, course of treatment, or prescription drug benefit.
200 The commission may adopt rules prescribing such necessary
201 information.
202 (3) The Financial Services Commission, in consultation with
203 the Agency for Health Care Administration, shall adopt by rule
204 guidelines for all prior authorization forms which ensure the
205 general uniformity of such forms.
206 (4) Electronic prior authorization approvals do not
207 preclude benefit verification or medical review by the insurer
208 under either the medical or pharmacy benefits.
209 (5) A health insurer, or a pharmacy benefits manager on
210 behalf of the health insurer, shall provide upon request the
211 following information in writing or in an electronic format and
212 publish it on a publicly accessible website:
213 (a) Detailed descriptions in clear, easily understandable
214 language of the requirements for, and restrictions on, obtaining
215 prior authorization for coverage of a medical procedure, course
216 of treatment, or prescription drug. Clinical criteria must be
217 described in language a health care provider can easily
218 understand.
219 (b) Prior authorization forms.
220 (6) A health insurer, or a pharmacy benefits manager on
221 behalf of the health insurer, may not implement any new
222 requirements or restrictions or make changes to existing
223 requirements or restrictions on obtaining prior authorization
224 unless:
225 (a) The changes have been available on a publicly
226 accessible website for at least 60 days before they are
227 implemented; and
228 (b) Policyholders and health care providers who are
229 affected by the new requirements and restrictions or changes to
230 the requirements and restrictions are provided with a written
231 notice of the changes at least 60 days before they are
232 implemented. Such notice may be delivered electronically or by
233 other means as agreed to by the insured or the health care
234 provider.
235
236 This subsection does not apply to the expansion of health care
237 services coverage.
238 (7) A health insurer, or a pharmacy benefits manager on
239 behalf of the health insurer, must authorize or deny a prior
240 authorization request and notify the patient and the patient’s
241 treating health care provider of the decision within:
242 (a) Seventy-two hours after receiving a completed prior
243 authorization form for nonurgent care situations.
244 (b) Twenty-four hours after receiving a completed prior
245 authorization form for urgent care situations.
246 Section 3. Section 627.42393, Florida Statutes, is amended
247 to read:
248 627.42393 Step-therapy protocol restrictions and
249 exceptions.—
250 (1) DEFINITIONS.—As used in this section, the term:
251 (a) “Health coverage plan” means any of the following which
252 is currently or was previously providing major medical or
253 similar comprehensive coverage or benefits to the insured:
254 1. A health insurer or health maintenance organization.
255 2. A plan established or maintained by an individual
256 employer as provided by the Employee Retirement Income Security
257 Act of 1974, Pub. L. No. 93-406.
258 3. A multiple-employer welfare arrangement as defined in s.
259 624.437.
260 4. A governmental entity providing a plan of self
261 insurance.
262 (b) “Health insurer” has the same meaning as provided in s.
263 627.42392.
264 (c) “Preceding prescription drug or medical treatment”
265 means a prescription drug, medical procedure, or course of
266 treatment that must be used pursuant to a health insurer’s step
267 therapy protocol as a condition of coverage under a health
268 insurance policy to treat an insured’s condition.
269 (d) “Protocol exception” means a determination by a health
270 insurer that a step-therapy protocol is not medically
271 appropriate or indicated for treatment of an insured’s
272 condition, and the health insurer authorizes the use of another
273 medical procedure, course of treatment, or prescription drug
274 prescribed or recommended by the treating health care provider
275 for the insured’s condition.
276 (e) “Step-therapy protocol” means a written protocol that
277 specifies the order in which certain medical procedures, courses
278 of treatment, or prescription drugs must be used to treat an
279 insured’s condition.
280 (f) “Urgent care situation” means an injury or condition of
281 an insured which, if medical care and treatment are not provided
282 earlier than the time the medical profession generally considers
283 reasonable for a nonurgent situation, in the opinion of the
284 insured’s treating physician, physician assistant, or advanced
285 practice registered nurse, would:
286 1. Seriously jeopardize the insured’s life, health, or
287 ability to regain maximum function; or
288 2. Subject the insured to severe pain that cannot be
289 adequately managed.
290 (2) STEP-THERAPY PROTOCOL RESTRICTIONS.—In addition to
291 protocol exceptions granted under subsection (3) and the
292 restriction under s. 627.4239(3), a health insurer issuing a
293 major medical individual or group policy may not require a step
294 therapy protocol under the policy for a covered prescription
295 drug requested by an insured if:
296 (a) The insured has previously been approved to receive the
297 prescription drug through the completion of a step-therapy
298 protocol required by a separate health coverage plan; and
299 (b) The insured provides documentation originating from the
300 health coverage plan that approved the prescription drug as
301 described in paragraph (a) indicating that the health coverage
302 plan paid for the drug on the insured’s behalf during the 90
303 days immediately before the request.
304 (3) STEP-THERAPY PROTOCOL EXCEPTIONS; REQUIREMENTS AND
305 PROCEDURES.—
306 (a) A health insurer shall publish on its website and
307 provide to an insured in writing a procedure for the insured and
308 his or her health care provider to request a protocol exception.
309 The procedure must include:
310 1. The manner in which an insured or health care provider
311 may request a protocol exception.
312 2. The manner and timeframe in which the health insurer is
313 required to authorize or deny a protocol exception request or to
314 respond to an appeal of the health insurer’s authorization or
315 denial of a request.
316 3. The conditions under which the protocol exception
317 request must be granted.
318 (b)1. A health insurer must authorize or deny a protocol
319 exception request or respond to an appeal of a health insurer’s
320 authorization or denial of a request within:
321 a. Seventy-two hours after receiving a completed prior
322 authorization form for nonurgent care situations.
323 b. Twenty-four hours after receiving a completed prior
324 authorization form for urgent care situations.
325 2. An authorization of the request must specify the
326 approved medical procedure, course of treatment, or prescription
327 drug benefits.
328 3. A denial of the request must include a detailed written
329 explanation of the reason for the denial, the clinical rationale
330 that supports the denial, and the procedure for appealing the
331 health insurer’s determination.
332 (c) A health insurer must grant a protocol exception
333 request if any of the following applies:
334 1. A preceding prescription drug or medical treatment is
335 contraindicated or will likely cause an adverse reaction or
336 physical or mental harm to the insured.
337 2. A preceding prescription drug or medical treatment is
338 expected to be ineffective based on the insured’s medical
339 history and the clinical evidence of the characteristics of the
340 preceding prescription drug or medical treatment.
341 3. The insured has previously received a preceding
342 prescription drug or medical treatment that is in the same
343 pharmacologic class or has the same mechanism of action and such
344 drug or treatment lacked efficacy or effectiveness or adversely
345 affected the insured.
346 4. A preceding prescription drug or medical treatment is
347 not in the insured’s best interest because his or her use of the
348 drug or treatment is expected to:
349 a. Cause a significant barrier to the insured’s adherence
350 to or compliance with his or her plan of care;
351 b. Worsen the insured’s medical condition that exists
352 simultaneously with, but independently of, the condition under
353 treatment; or
354 c. Decrease the insured’s ability to achieve or maintain
355 his or her ability to perform daily activities.
356 5. A preceding prescription drug is an opioid and the
357 protocol exception request is for a nonopioid prescription drug
358 or treatment with a likelihood of similar or better results.
359 (d) A health insurer may request a copy of relevant
360 documentation from an insured’s medical record in support of a
361 protocol exception request.
362 (2) As used in this section, the term “health coverage
363 plan” means any of the following which is currently or was
364 previously providing major medical or similar comprehensive
365 coverage or benefits to the insured:
366 (a) A health insurer or health maintenance organization.
367 (b) A plan established or maintained by an individual
368 employer as provided by the Employee Retirement Income Security
369 Act of 1974, Pub. L. No. 93-406.
370 (c) A multiple-employer welfare arrangement as defined in
371 s. 624.437.
372 (d) A governmental entity providing a plan of self
373 insurance.
374 (4)(3) CONSTRUCTION.—This section does not require a health
375 insurer to add a drug to its prescription drug formulary or to
376 cover a prescription drug that the insurer does not otherwise
377 cover.
378 Section 4. Subsection (11) of section 627.6131, Florida
379 Statutes, is amended, and subsection (20) is added to that
380 section, to read:
381 627.6131 Payment of claims.—
382 (11) A health insurer may not retroactively deny a claim
383 because of insured ineligibility:
384 (a) More than 1 year after the date of payment of the
385 claim; or
386 (b) At any time, if the health insurer verified the
387 insured’s eligibility at the time of treatment or provided an
388 authorization number.
389 (20) A health insurer may not impose an additional prior
390 authorization requirement with respect to a surgical or
391 otherwise invasive procedure, or any item furnished as part of
392 the surgical or invasive procedure, if the procedure or item is
393 furnished during the perioperative period of another procedure
394 for which prior authorization was granted by the health insurer.
395 Section 5. Subsection (46) of section 641.31, Florida
396 Statutes, is amended to read:
397 641.31 Health maintenance contracts.—
398 (46)(a) Definitions.—As used in this subsection, the term:
399 1. “Health coverage plan” means any of the following which
400 is currently or was previously providing major medical or
401 similar comprehensive coverage or benefits to the subscriber:
402 a. A health insurer or health maintenance organization.
403 b. A plan established or maintained by an individual
404 employer as provided by the Employee Retirement Income Security
405 Act of 1974, Pub. L. No. 93-406.
406 c. A multiple-employer welfare arrangement as defined in s.
407 624.437.
408 d. A governmental entity providing a plan of self
409 insurance.
410 2. “Preceding prescription drug or medical treatment” means
411 a prescription drug, medical procedure, or course of treatment
412 that must be used pursuant to a health maintenance
413 organization’s step-therapy protocol as a condition of coverage
414 under a health maintenance contract to treat a subscriber’s
415 condition.
416 3. “Protocol exception” means a determination by a health
417 maintenance organization that a step-therapy protocol is not
418 medically appropriate or indicated for treatment of a
419 subscriber’s condition, and the health maintenance organization
420 authorizes the use of another medical procedure, course of
421 treatment, or prescription drug prescribed or recommended by the
422 treating health care provider for the subscriber’s condition.
423 4. “Step-therapy protocol” means a written protocol that
424 specifies the order in which certain medical procedures, courses
425 of treatment, or prescription drugs must be used to treat a
426 subscriber’s condition.
427 5. “Urgent care situation” means an injury or condition of
428 a subscriber which, if medical care and treatment are not
429 provided earlier than the time the medical profession generally
430 considers reasonable for a nonurgent situation, in the opinion
431 of the subscriber’s treating physician, physician assistant, or
432 advanced practice registered nurse, would:
433 a. Seriously jeopardize the subscriber’s life, health, or
434 ability to regain maximum function; or
435 b. Subject the subscriber to severe pain that cannot be
436 adequately managed.
437 (b) Step-therapy protocol restrictions.—In addition to
438 protocol exceptions granted under paragraph (c) and the
439 restriction under s. 627.4239(3), a health maintenance
440 organization issuing major medical coverage through an
441 individual or group contract may not require a step-therapy
442 protocol under the contract for a covered prescription drug
443 requested by a subscriber if:
444 1. The subscriber has previously been approved to receive
445 the prescription drug through the completion of a step-therapy
446 protocol required by a separate health coverage plan; and
447 2. The subscriber provides documentation originating from
448 the health coverage plan that approved the prescription drug as
449 described in subparagraph 1. indicating that the health coverage
450 plan paid for the drug on the subscriber’s behalf during the 90
451 days immediately before the request.
452 (c) Step-therapy protocol exceptions; requirements and
453 procedures.—
454 1. A health maintenance organization shall publish on its
455 website and provide to a subscriber in writing a procedure for
456 the subscriber and his or her health care provider to request a
457 protocol exception. The procedure must include:
458 a. The manner in which a subscriber or health care provider
459 may request a protocol exception.
460 b. The manner and timeframe in which the health maintenance
461 organization is required to authorize or deny a protocol
462 exception request or to respond to an appeal of the health
463 maintenance organization’s authorization or denial of a request.
464 c. The conditions under which the protocol exception
465 request must be granted.
466 2.a. A health maintenance organization must authorize or
467 deny a protocol exception request or respond to an appeal of a
468 health maintenance organization’s authorization or denial of a
469 request within:
470 (I) Seventy-two hours after receiving a completed prior
471 authorization form for nonurgent care situations.
472 (II) Twenty-four hours after receiving a completed prior
473 authorization form for urgent care situations.
474 b. An authorization of the request must specify the
475 approved medical procedure, course of treatment, or prescription
476 drug benefits.
477 c. A denial of the request must include a detailed written
478 explanation of the reason for the denial, the clinical rationale
479 that supports the denial, and the procedure for appealing the
480 health maintenance organization’s determination.
481 3. A health maintenance organization must grant a protocol
482 exception request if any of the following applies:
483 a. A preceding prescription drug or medical treatment is
484 contraindicated or will likely cause an adverse reaction or
485 physical or mental harm to the subscriber.
486 b. A preceding prescription drug or medical treatment is
487 expected to be ineffective based on the subscriber’s medical
488 history and the clinical evidence of the characteristics of the
489 preceding prescription drug or medical treatment.
490 c. The subscriber has previously received a preceding
491 prescription drug or medical treatment that is in the same
492 pharmacologic class or has the same mechanism of action and such
493 drug or treatment lacked efficacy or effectiveness or adversely
494 affected the subscriber.
495 d. A preceding prescription drug or medical treatment is
496 not in the subscriber’s best interest because his or her use of
497 the drug or treatment is expected to:
498 (I) Cause a significant barrier to the subscriber’s
499 adherence to or compliance with his or her plan of care;
500 (II) Worsen the subscriber’s medical condition that exists
501 simultaneously with, but independently of, the condition under
502 treatment; or
503 (III) Decrease the subscriber’s ability to achieve or
504 maintain his or her ability to perform daily activities.
505 e. A preceding prescription drug is an opioid and the
506 protocol exception request is for a nonopioid prescription drug
507 or treatment with a likelihood of similar or better results.
508 4. A health maintenance organization may request a copy of
509 relevant documentation from a subscriber’s medical record in
510 support of a protocol exception request.
511 (b) As used in this subsection, the term “health coverage
512 plan” means any of the following which previously provided or is
513 currently providing major medical or similar comprehensive
514 coverage or benefits to the subscriber:
515 1. A health insurer or health maintenance organization;
516 2. A plan established or maintained by an individual
517 employer as provided by the Employee Retirement Income Security
518 Act of 1974, Pub. L. No. 93-406;
519 3. A multiple-employer welfare arrangement as defined in s.
520 624.437; or
521 4. A governmental entity providing a plan of self
522 insurance.
523 (d)(c) Construction.—This subsection does not require a
524 health maintenance organization to add a drug to its
525 prescription drug formulary or to cover a prescription drug that
526 the health maintenance organization does not otherwise cover.
527 Section 6. Subsection (10) of section 641.3155, Florida
528 Statutes, is amended to read:
529 641.3155 Prompt payment of claims.—
530 (10) A health maintenance organization may not
531 retroactively deny a claim because of subscriber ineligibility:
532 (a) More than 1 year after the date of payment of the
533 claim; or
534 (b) At any time, if the health maintenance organization
535 verified the subscriber’s eligibility at the time of treatment
536 or provided an authorization number.
537 Section 7. Subsection (4) is added to section 641.3156,
538 Florida Statutes, to read:
539 641.3156 Treatment authorization; payment of claims.—
540 (4) A health maintenance organization may not impose an
541 additional prior authorization requirement with respect to a
542 surgical or otherwise invasive procedure, or any item furnished
543 as part of the surgical or invasive procedure, if the procedure
544 or item is furnished during the perioperative period of another
545 procedure for which prior authorization was granted by the
546 health maintenance organization.
547 Section 8. This act shall take effect January 1, 2021.