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SB3,10,1210 b. The subject of a notice, guidance, warning, announcement, or other
11statement from the federal food and drug administration relating to concerns about
12the safety of the prescription drug.
SB3,10,1413 c. Approved by the federal food and drug administration for use without a
14prescription.
SB3,10,2215 2. A disability insurance policy, self-insured health plan, or pharmacy benefit
16manager is not required to provide advanced written notice under par. (a) if, for the
17prescription drug that is being removed from the formulary or reassigned to a benefit
18tier that has a higher deductible, copayment, or coinsurance, the policy, plan, or
19pharmacy benefit manager adds to the formulary a generic prescription drug that
20is approved by the federal food and drug administration for use as an alternative to
21the prescription drug or a prescription drug in the same pharmacologic class or with
22the same mechanism of action at any of the following benefit tiers:
SB3,10,2423 a. The same benefit tier from which the prescription drug is being removed or
24reassigned.
SB3,11,2
1b. A benefit tier that has a lower deductible, copayment, or coinsurance than
2the benefit tier from which the prescription drug is being removed or reassigned.
SB3,11,103 (c) A pharmacist or pharmacy shall notify an enrollee in a disability insurance
4policy or self-insured health plan if a prescription drug for which an enrollee is filling
5or refilling a prescription is removed from the formulary and the policy or plan or a
6pharmacy benefit manager acting on behalf of a policy or plan adds to the formulary
7a generic prescription drug that is approved by the federal food and drug
8administration for use as an alternative to the prescription drug or a prescription
9drug in the same pharmacologic class or with the same mechanism of action at any
10of the following benefit tiers:
SB3,11,1211 1. The same benefit tier from which the prescription drug is being removed or
12reassigned.
SB3,11,1413 2. A benefit tier that has a lower deductible, copayment, or coinsurance than
14the benefit tier from which the prescription drug is being removed or reassigned.
SB3,11,2115 (d) If an enrollee has had an adverse reaction to the generic prescription drug
16or the prescription drug in the same pharmacologic class or with the same
17mechanism of action that is being substituted for an originally prescribed drug, the
18pharmacist or pharmacy may extend the prescription order for the originally
19prescribed drug to fill one 30-day supply of the originally prescribed drug for the
20cost-sharing amount that applies to the prescription drug at the time of the
21substitution.
SB3,16 22Section 16 . 632.865 (1) (a) of the statutes is renumbered 632.865 (1) (aw).
SB3,17 23Section 17 . 632.865 (1) (ae) and (ak) of the statutes are created to read:
SB3,11,2424 632.865 (1) (ae) “Health benefit plan” has the meaning given in s. 632.745 (11).
SB3,11,2525 (ak) “Health care provider” has the meaning given in s. 146.81 (1).
SB3,18
1Section 18. 632.865 (1) (c) of the statutes is renumbered 632.865 (1) (c) (intro.)
2and amended to read:
SB3,12,53 632.865 (1) (c) (intro.) “Pharmacy benefit manager" means an entity doing
4business in this state that contracts to administer or manage prescription drug
5benefits on behalf of any of the following:
SB3,12,6 61. An insurer or other.
SB3,12,8 73. Another entity that provides prescription drug benefits to residents of this
8state.
SB3,19 9Section 19 . 632.865 (1) (c) 2. of the statutes is created to read:
SB3,12,1010 632.865 (1) (c) 2. A cooperative, as defined in s. 185.01 (2).
SB3,20 11Section 20 . 632.865 (1) (dm) of the statutes is created to read:
SB3,12,1212 632.865 (1) (dm) “Prescription drug" has the meaning given in s. 450.01 (20).
SB3,21 13Section 21 . 632.865 (3) to (7) of the statutes are created to read:
SB3,12,1614 632.865 (3) License required. No person may perform any activities of a
15pharmacy benefit manager without being licensed by the commissioner as an
16administrator or pharmacy benefit manager under s. 633.14.
SB3,12,23 17(4) Accreditation for network participation. A pharmacy benefit manager or
18a representative of a pharmacy benefit manager shall provide to a pharmacy, within
1930 days of receipt of a written request from the pharmacy, a written notice of any
20certification or accreditation requirements used by the pharmacy benefit manager
21or its representative as a determinant of network participation. A pharmacy benefit
22manager or a representative of a pharmacy benefit manager may change its
23accreditation requirements no more frequently than once every 12 months.
SB3,13,3
1(5) Retroactive claim reduction. Unless required otherwise by federal law,
2a pharmacy benefit manager may not retroactively deny or reduce a pharmacist's or
3pharmacy's claim after adjudication of the claim unless any of the following is true:
SB3,13,44 (a) The original claim was submitted fraudulently.
SB3,13,75 (b) The payment for the original claim was incorrect. Recovery for an incorrect
6payment under this paragraph is limited to the amount that exceeds the allowable
7claim.
SB3,13,88 (c) The pharmacy services were not rendered by the pharmacist or pharmacy.
SB3,13,109 (d) In making the claim or performing the service that is the basis for the claim,
10the pharmacist or pharmacy violated state or federal law.
SB3,13,1211 (e) The reduction is permitted in a contract between a pharmacy and a
12pharmacy benefit manager and is related to a quality program.
SB3,13,13 13(6) Audits of pharmacies or pharmacists. (a) Definitions. In this subsection:
SB3,13,1614 1. “Audit” means a review of the accounts and records of a pharmacy or
15pharmacist by or on behalf of an entity that finances or reimburses the cost of health
16care services or prescription drugs.
SB3,13,2017 2. “Entity” means a defined network plan, as defined in s. 609.01 (1b), insurer,
18self-insured health plan, or pharmacy benefit manager or a person acting on behalf
19of a defined network plan, insurer, self-insured health plan, or pharmacy benefit
20manager.
SB3,13,2121 3. “Self-insured health plan” has the meaning given in s. 632.85 (1) (c).
SB3,13,2322 (b) Procedures. An entity conducting an on-site or desk audit of pharmacist
23or pharmacy records shall do all of the following:
SB3,14,3
11. If the audit is an audit on the premises of the pharmacist or pharmacy, notify
2the pharmacist or pharmacy in writing of the audit at least 2 weeks before conducting
3the audit.
SB3,14,64 2. Refrain from auditing a pharmacist or pharmacy within the first 5 business
5days of a month unless the pharmacist or pharmacy consents to an audit during that
6time.
SB3,14,87 3. If the audit involves clinical or professional judgment, conduct the audit by
8or in consultation with a pharmacist licensed in any state.
SB3,14,109 4. Limit the audit review to no more than 250 separate prescriptions. For
10purposes of this subdivision, a refill of a prescription is not a separate prescription.
SB3,14,1211 5. Limit the audit review to claims submitted no more than 2 years before the
12date of the audit, unless required otherwise by state or federal law.
SB3,14,1813 6. Allow the pharmacist or pharmacy to use authentic and verifiable records
14of a hospital, physician, or other health care provider to validate the pharmacist's or
15pharmacy's records relating to delivery of a prescription drug and use any valid
16prescription that complies with requirements of the pharmacy examining board to
17validate claims in connection with a prescription, refill of a prescription, or change
18in prescription.
SB3,14,2119 7. Allow the pharmacy or pharmacist to document the delivery of a prescription
20drug or pharmacist services to an enrollee under a health benefit plan using either
21paper or electronic signature logs.
SB3,14,2422 8. Before leaving the pharmacy after concluding the on-site portion of an audit,
23provide to the representative of the pharmacy or the pharmacist a complete list of
24the pharmacy records reviewed.
SB3,15,2
1(c) Results of audit. An entity that has conducted an audit of a pharmacist or
2pharmacy shall do all of the following:
SB3,15,103 1. Deliver to the pharmacist or pharmacy a preliminary report of the audit
4within 60 days after the date the auditor departs from an on-site audit or the
5pharmacy or pharmacist submits paperwork for a desk audit. A preliminary report
6under this subdivision shall include claim-level information for any discrepancy
7reported, the estimated total amount of claims subject to recovery, and contact
8information for the entity or person that completed the audit so the pharmacist or
9pharmacy subject to the audit may review audit results, procedures, and
10discrepancies.
SB3,15,1311 2. Allow a pharmacist or pharmacy that is the subject of an audit to provide
12documentation to address any discrepancy found in the audit within 30 days after
13the date the pharmacist or pharmacy receives the preliminary report.
SB3,15,1914 3. Deliver to the pharmacist or pharmacy a final audit report, which may be
15delivered electronically, within 90 days of the date the pharmacist or pharmacy
16receives the preliminary report or the date of the final appeal of the audit, whichever
17is later. The final audit report under this subdivision shall include any response
18provided to the auditor by the pharmacy or pharmacist and consider and address the
19pharmacy's or pharmacist's response.
SB3,15,2220 4. Refrain from assessing a recoupment or other penalty on a pharmacist or
21pharmacy until the appeal process is exhausted and the final report under subd. 3.
22is delivered to the pharmacist or pharmacy.
SB3,15,2423 5. Refrain from accruing or charging interest between the time the notice of the
24audit is given under par. (b) 1. and the final report under subd. 3. has been delivered.
SB3,15,2525 6. Exclude dispensing fees from calculations of overpayments.
SB3,16,4
17. Establish and follow a written appeals process that allows a pharmacy or
2pharmacist to appeal the final report of an audit and allow the pharmacy or
3pharmacist as part of the appeal process to arrange for, at the cost of the pharmacy
4or pharmacist, an independent audit.
SB3,16,85 8. Refrain from subjecting the pharmacy or pharmacist to a recoupment or
6recovery for a clerical or record-keeping error in a required document or record,
7including a typographical or computer error, unless the error resulted in an
8overpayment to the pharmacy or pharmacist.
SB3,16,149 (d) Confidentiality of audit. Information obtained in an audit under this
10subsection is confidential and may not be shared unless the information is required
11to be shared under state or federal law and except that the audit may be shared with
12the entity on whose behalf the audit is performed. An entity conducting an audit may
13have access to the previous audit reports on a particular pharmacy only if the audit
14is conducted by the same entity.
SB3,16,1815 (e) Cooperation with audit. If an entity is conducting an audit that is complying
16with this subsection in auditing a pharmacy or pharmacist, the pharmacy or
17pharmacist that is the subject of the audit may not interfere with or refuse to
18participate in the audit.
SB3,16,2119 (f) Payment of auditors. A pharmacy benefit manager or entity conducting an
20audit may not pay an auditor employed by or contracted with the pharmacy benefit
21manager or entity based on a percentage of the amount recovered in an audit.
SB3,16,2422 (g) Applicability. 1. This subsection does not apply to an investigative audit
23that is initiated as a result of a credible allegation of fraud or willful
24misrepresentation or criminal wrongdoing.
SB3,17,3
12. If an entity conducts an audit to which a federal law applies that is in conflict
2with all or part of this subsection, the entity shall comply with this subsection only
3to the extent that it does not conflict with federal law.
SB3,17,11 4(7) Transparency reports. (a) Beginning on June 1, 2021, and annually
5thereafter, every pharmacy benefit manager shall submit to the commissioner a
6report that contains, from the previous calendar year, the aggregate rebate amount
7that the pharmacy benefit manager received from all pharmaceutical manufacturers
8but retained and did not pass through to health benefit plan sponsors and the
9percentage of the aggregate rebate amount that is retained rebates. Information
10required under this paragraph is limited to contracts held with pharmacies located
11in this state.
SB3,17,1312 (b) Reports under this subsection shall be considered a trade secret under the
13uniform trade secret act under s. 134.90.
SB3,17,1514 (c) The commissioner may not expand upon the reporting requirement under
15this subsection, except that the commissioner may effectuate this subsection.
SB3,22 16Section 22 . Chapter 633 (title) of the statutes is amended to read:
SB3,17,2017 CHAPTER 633
18 EMPLOYEE BENEFIT PLAN
19 ADMINISTRATORS AND, PRINCIPALS ,
20 and Pharmacy benefit managers
SB3,23 21Section 23 . 633.01 (1) (intro.) and (c) of the statutes are amended to read:
SB3,17,2522 633.01 (1) (intro.) “Administrator" means a person who directly or indirectly
23solicits or collects premiums or charges or otherwise effects coverage or adjusts or
24settles claims for a an employee benefit plan, but does not include the following
25persons if they perform these acts under the circumstances specified for each:
SB3,18,3
1(c) A creditor on behalf of its debtor, if to obtain payment, reimbursement or
2other method of satisfaction from a an employee benefit plan for any part of a debt
3owed to the creditor by the debtor.
SB3,24 4Section 24 . 633.01 (2r) of the statutes is created to read:
SB3,18,55 633.01 (2r) “Enrollee” has the meaning given in s. 632.861 (1) (b).
SB3,25 6Section 25 . 633.01 (3) of the statutes is amended to read:
SB3,18,87 633.01 (3) “Insured employee" means an employee who is a resident of this
8state and who is covered under a an employee benefit plan.
SB3,26 9Section 26 . 633.01 (4) of the statutes is renumbered 633.01 (2g) and amended
10to read:
SB3,18,1611 633.01 (2g)Plan Employee benefit plan" means an insured or wholly or
12partially self-insured employee benefit plan which by means of direct payment,
13reimbursement or other arrangement provides to one or more employees who are
14residents of this state benefits or services that include, but are not limited to, benefits
15for medical, surgical or hospital care, benefits in the event of sickness, accident,
16disability or death, or benefits in the event of unemployment or retirement.
SB3,27 17Section 27 . 633.01 (4g) of the statutes is created to read:
SB3,18,1918 633.01 (4g) “Pharmacy benefit manager” has the meaning given in s. 632.865
19(1) (c).
SB3,28 20Section 28 . 633.01 (4r) of the statutes is created to read:
SB3,18,2221 633.01 (4r) “Prescription drug benefit” has the meaning given in s. 632.865 (1)
22(e).
SB3,29 23Section 29 . 633.01 (5) of the statutes is amended to read:
SB3,18,2524 633.01 (5) “Principal" means a person, including an insurer, that uses the
25services of an administrator to provide a an employee benefit plan.
SB3,30
1Section 30. 633.01 (6) of the statutes is created to read:
SB3,19,22 633.01 (6) “Self-insured health plan" has the meaning given in s. 632.85 (1) (c).
SB3,31 3Section 31 . 633.04 (intro.) of the statutes is amended to read:
SB3,19,8 4633.04 Written agreement required. (intro.) An administrator may not
5administer a an employee benefit plan in the absence of a written agreement
6between the administrator and a principal. The administrator and principal shall
7each retain a copy of the written agreement for the duration of the agreement and
8for 5 years thereafter. The written agreement shall contain the following terms:
SB3,32 9Section 32 . 633.05 of the statutes is amended to read:
SB3,19,16 10633.05 Payment to administrator. If a principal is an insurer, payment to
11the administrator of a premium or charge by or on behalf of an insured employee is
12payment to the insurer, but payment of a return premium or claim by the insurer to
13the administrator is not payment to an insured employee until the payment is
14received by the insured employee. This section does not limit any right of the insurer
15against the administrator for failure to make payments to the insurer or an insured
16employee.
SB3,33 17Section 33 . 633.06 of the statutes is amended to read:
SB3,19,22 18633.06 Examination and inspection of books and records. (1) The
19commissioner may examine, audit or accept an audit of the books and records of an
20administrator or pharmacy benefit manager as provided for examination of licensees
21under s. 601.43 (1), (3), (4) and (5), to be conducted as provided in s. 601.44, and with
22costs to be paid as provided in s. 601.45.
SB3,20,2 23(2) A principal that uses an administrator may inspect the books and records
24of the administrator, subject to any restrictions set forth in ss. 146.81 to 146.835 and

1in the written agreement required under s. 633.04, for the purpose of enabling the
2principal to fulfill its contractual obligations to insureds insured employees.
SB3,34 3Section 34 . 633.07 of the statutes is amended to read:
SB3,20,6 4633.07 Approval of advertising. An administrator may not use any
5advertising for a an employee benefit plan underwritten by an insurer unless the
6insurer approves the advertising in advance.
SB3,35 7Section 35 . 633.09 (4) (b) 2. and 3. of the statutes are amended to read:
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