632.853
632.853
Coverage of drugs and devices. A health care plan, as defined in s.
628.36 (2) (a) 1., or a self-insured health plan, as defined in s.
632.85 (1) (c), that provides coverage of only certain specified prescription drugs or devices shall develop a process through which a physician may present medical evidence to obtain an individual patient exception for coverage of a prescription drug or device not routinely covered by the plan. The process shall include timelines for both urgent and nonurgent review.
632.853 History
History: 1997 a. 237.
632.855
632.855
Requirements if experimental treatment limited. 632.855(2)
(2) Disclosure of limitations. Subject to s.
632.87 (6), a health care plan or a self-insured health plan that limits coverage of experimental treatment shall define the limitation and disclose the limits in any agreement, policy or certificate of coverage. This disclosure shall include the following information:
632.855(2)(a)
(a) Who is authorized to make a determination on the limitation.
632.855(2)(b)
(b) The criteria the plan uses to determine whether a treatment, procedure, drug or device is experimental.
632.855(3)(am)
(am) A health care plan or a self-insured health plan that receives a request for prior authorization of an experimental procedure that includes all of the required information upon which to make a decision shall, within 5 working days after receiving the request, issue a coverage decision. If the health care plan or self-insured health plan denies coverage of an experimental treatment, procedure, drug or device for an insured who has a terminal condition or illness, the health care plan or self-insured health plan shall, as part of its coverage decision, provide the insured with a denial letter that includes all of the following:
632.855(3)(am)1.
1. A statement setting forth the specific medical and scientific reasons for denying coverage.
632.855(3)(am)2.
2. Notice of the insured's right to appeal and a description of the appeal procedure.
632.855(3)(bm)
(bm) A health care plan or a self-insured health plan may not deny coverage under par.
(am) of an experimental treatment, procedure, drug, or device for an insured if the denial violates s.
632.87 (6).
632.855 History
History: 1997 a. 237;
2005 a. 194.
632.857
632.857
Explanation required for restriction or termination of coverage. If an insurer restricts or terminates an insured's coverage for the treatment of a condition or complaint and, as a result, the insured becomes liable for payment for all of his or her treatment for the condition or complaint, the insurer shall provide on the explanation of benefits form a detailed explanation of the clinical rationale and of the basis in the policy, plan, or contract or in applicable law for the insurer's restriction or termination of coverage.
632.857 History
History: 2007 a. 20.
632.86
632.86
Restrictions on pharmaceutical services. 632.86(1)(a)
(a) “Disability insurance policy" has the meaning given in s.
632.895 (1) (a), except that the term does not include coverage under a health maintenance organization, as defined in s.
609.01 (2), a limited service health organization, as defined in s.
609.01 (3), a preferred provider plan, as defined in s.
609.01 (4), or a health care plan operated by a cooperative association organized under s.
185.981.
632.86(1)(b)
(b) “Pharmaceutical mail order plan" means a plan under which prescribed drugs or devices are dispensed through the mail.
632.86(2)
(2) No group or blanket disability insurance policy that provides coverage of prescribed drugs or devices through a pharmaceutical mail order plan may do any of the following:
632.86(2)(a)
(a) Exclude coverage, expressly or by implication, of any prescribed drug or device provided by a pharmacist or pharmacy selected by a covered individual if the pharmacist or pharmacy provides or agrees to provide prescribed drugs or devices under the terms of the policy and at the same cost to the insurer issuing the policy as a pharmaceutical mail order plan.
632.86(2)(b)
(b) Contain coverage, deductible or copayment provisions for prescribed drugs or devices provided by a pharmacist or pharmacy selected by a covered individual that are different from the coverage, deductible or copayment provisions for prescribed drugs or devices provided by a pharmaceutical mail order plan.
632.86 History
History: 1991 a. 70;
2009 a. 165.
632.865
632.865
Pharmacy benefit managers. 632.865(1)(c)
(c) “Pharmacy benefit manager" means an entity doing business in this state that contracts to administer or manage prescription drug benefits on behalf of any insurer or other entity that provides prescription drug benefits to residents of this state.
632.865(1)(e)
(e) “Prescription drug benefit" means coverage of or payment or assistance for prescribed drugs or devices.
632.865(2)(a)
(a) The pharmacy benefit manager shall agree in each contract or renewal to do all of the following:
632.865(2)(a)1.
1. Update maximum allowable cost pricing information for prescribed drugs or devices at least every 7 business days and provide a means by which contracted pharmacies may promptly review pricing updates in a format that is readily available and accessible.
632.865(2)(a)2.
2. Reimburse pharmacists and pharmacies for prescribed drugs or devices subject to maximum allowable cost information that has been updated at least every 7 business days.
632.865(2)(a)3.
3. Eliminate prescribed drugs or devices from the maximum allowable cost information or modify maximum allowable cost in a timely fashion consistent with availability of prescribed drugs or devices and pricing changes in the marketplace.
632.865(2)(b)
(b) A pharmacy benefit manger shall include in each contract with a pharmacy a process to appeal, investigate, and resolve disputes regarding maximum allowable cost pricing that includes all of the following:
632.865(2)(b)1.
1. A 21-day limit on the right to appeal following the initial claim.
632.865(2)(b)2.
2. A requirement that the appeal be investigated and resolved within 21 days after the date of the appeal.
632.865(2)(b)3.
3. A dedicated telephone number at which the pharmacy may contact the pharmacy benefit manager to speak to a person responsible for processing appeals.
632.865(2)(b)4.
4. A requirement that a pharmacy benefit manager provide a reason for any appeal denial and the national drug code published in a directory by the federal food and drug administration of a prescribed drug or device that may be purchased by retail network pharmacies at a price at or below the maximum allowable cost.
632.865(2)(b)5.
5. A requirement that a pharmacy benefit manager make a pricing adjustment no later than one day after the date of the final determination of the appeal.
632.865 History
History: 2015 a. 55.
632.866
632.866
Step therapy protocols. 632.866(1)(a)
(a) “Clinical practice guideline” means a systematically developed statement to assist decision making by health care providers and patients about appropriate health care for specific clinical circumstances and conditions.
632.866(1)(b)
(b) “Clinical review criteria” means written screening procedures, decision abstracts, clinical protocols, and clinical practice guidelines used by an insurer, pharmacy benefit manager, or utilization review organization to determine whether health care services are medically necessary and appropriate.
632.866(1)(c)
(c) “Exigent circumstances” means when a patient is suffering from a health condition that may seriously jeopardize the patient's life, health, or ability to regain maximum function.
632.866(1)(e)
(e) “Step therapy protocol” means a protocol or program that establishes the specific sequence in which prescription drugs for a specified medical condition, whether self-administered or physician-administered, that are medically appropriate for a particular patient are covered under a policy or plan.
632.866(1)(f)
(f) “Utilization review organization” means an entity that conducts utilization review, other than an insurer or pharmacy benefit manager performing utilization review for its own policy or plan.
632.866(2)(a)
(a) When establishing a step therapy protocol, an insurer, pharmacy benefit manager, or utilization review organization shall use clinical review criteria that are based on clinical practice guidelines that are derived from peer-review publications, evidence-based research, and widely accepted medical practice. If such clinical practice guidelines are unavailable, the insurer, pharmacy benefit manager, or utilization review organization shall derive clinical review criteria from peer-reviewed publications, evidence-based research, and widely accepted medical practice. The insurer, pharmacy benefit manager, or utilization review organization shall continually update the clinical review criteria based on an update to the clinical practice guidelines or a review of new evidence and research and newly developed treatments.
632.866(2)(b)
(b) Any individual involved in establishing a step therapy protocol under this subsection shall disclose to the insurer, pharmacy benefit manager, or utilization review organization any potential conflict of interest due to a financial or other relationship or payment from a pharmaceutical manufacturer and shall recuse himself or herself from voting on a decision regarding the step therapy protocol if he or she has a conflict of interest.
632.866(2)(c)
(c) An insurer, pharmacy benefit manager, or utilization review organization shall describe on its Internet site the process and criteria used for selecting and evaluating clinical practice guidelines used under par.
(a) to develop step therapy protocols.
632.866(2)(d)
(d) Nothing in this subsection shall be construed to require insurers, pharmacy benefit managers, or the state to create a new entity to develop clinical review criteria used for step therapy protocols.
632.866(3)
(3) Transparency of exceptions process. 632.866(3)(a)(a) When coverage of a prescription drug for the treatment of any medical condition is restricted for use by an insurer, pharmacy benefit manager, or utilization review organization through the use of a step therapy protocol, the insurer, pharmacy benefit manager, or utilization review organization shall provide access to a clear, readily accessible, and convenient process to request an exception to the step therapy protocol. An insurer, pharmacy benefit manager, or utilization review organization may use any existing medical exceptions process to satisfy the requirement under this paragraph. The exception process shall be made easily accessible on the Internet site of the insurer, pharmacy benefit manager, or utilization review organization.
632.866(3)(b)
(b) An insurer, pharmacy benefit manager, or utilization review organization shall grant an exception to the step therapy protocol if the prescribing provider submits complete, clinically relevant written documentation supporting a step therapy exception request and any of the following are satisfied:
632.866(3)(b)1.
1. The prescription drug required under the step therapy protocol is contraindicated or, due to a documented adverse event with a previous use or a documented medical condition, including a comorbid condition, is likely to do any of the following:
632.866(3)(b)1.b.
b. Decrease the ability to achieve or maintain reasonable functional ability in performing daily activities.
632.866(3)(b)2.
2. The prescription drug required under the step therapy protocol is expected to be ineffective based on all of the following:
632.866(3)(b)2.c.
c. The known characteristics of the prescription drug regimen as described in peer-reviewed literature or the manufacturer's prescribing information for the prescription drug.
632.866(3)(b)3.
3. The patient has tried the prescription drug required under the step therapy protocol, or another prescription drug in the same pharmacologic class or with the same mechanism of action, under the policy or plan or a previous policy or plan, the patient was adherent to the prescription drug regimen for a time that allows for a positive treatment outcome, and the patient's use of the prescription drug was discontinued by the patient's provider due to lack of efficacy or effectiveness, diminished effect, or adverse event. This subdivision does not prohibit an insurer, pharmacy benefit manager, or utilization review organization from requiring a patient to try another drug in the same pharmacologic class or with the same mechanism of action if that therapy sequence is supported by clinical review criteria under sub.
(2) (a).
632.866(3)(b)4.
4. The patient is stable on a prescription drug selected by his or her health care provider for the medical condition under consideration while covered under the policy or plan or a previous policy or plan.
632.866(3)(c)
(c) Nothing in this subsection shall be construed to allow the use of a pharmaceutical sample to satisfy a criterion for an exception to a step therapy protocol.
632.866(3)(d)
(d) Upon granting an exception to the step therapy protocol under par.
(b), the insurer, pharmacy benefit manager, or utilization review organization shall authorize coverage for the prescription drug prescribed by the patient's treating health care provider to the extent the prescribed drug is covered under the patient's policy or plan.
632.866(3)(e)
(e) An insured may appeal any request for an exception to the step therapy protocol that is denied.
632.866(3)(f)
(f) An insurer, pharmacy benefit manager, or utilization review organization shall grant or deny a request for any exception to the step therapy protocol within 3 business days of receipt of the complete, clinically relevant written documentation required under par.
(b) to support a step therapy exception request under par.
(b) or the receipt of a request to appeal a previous decision that includes the complete, clinically relevant written documentation supporting a step therapy exception request. In exigent circumstances, an insurer, pharmacy benefit manager, or utilization review organization shall grant or deny a request for an exception to the step therapy protocol by the end of the next business day after receipt of the complete, clinically relevant written documentation supporting a step therapy exception request under par.
(b). If the insurer, pharmacy benefit manager, or utilization review organization does not grant or deny a request or an appeal under the time specified under this paragraph, the exception is considered granted.
632.866(3)(g)
(g) Nothing in this subsection shall be construed to prevent any of the following:
632.866(3)(g)1.
1. An insurer, pharmacy benefit manager, or utilization review organization from requiring a patient to try an A-rated generic equivalent prescription drug, as designated by the federal food and drug administration, or a biosimilar, as defined under
42 USC 262 (i) (2), before providing coverage for the equivalent brand name prescription drug.
632.866(3)(g)2.
2. A health care provider from prescribing a prescription drug that is determined to be medically appropriate.
632.866(4)
(4) Rules. The commissioner shall promulgate any rules necessary to implement or enforce this section.
632.866 History
History: 2019 a. 12; s. 35.17 correction in (3) (a).
632.867
632.867
Oral and injected chemotherapy. 632.867(1)(a)
(a) “Chemotherapy" means drugs and biologics that kill cancer cells directly, including antineoplastics, biologic response modifiers, hormone therapy, and monoclonal antibodies, and that are used to do any of the following:
632.867(1)(a)4.
4. Destroy microscopic cancer cells that may be present after a tumor is removed by surgery to prevent a cancer recurrence.
