AB7,7,1917
601.46
(3) (b) A general review of the insurance business in this state, including
18a report on emerging regulatory problems, developments and trends
, including
19trends related to prescription drugs;
AB7,12
20Section 12
. 609.83 of the statutes is amended to read:
AB7,7,23
21609.83 Coverage of drugs and devices. Limited service health
22organizations, preferred provider plans, and defined network plans are subject to ss.
23632.853
, 632.861, and 632.895 (16t) and (16v).
AB7,13
24Section 13
. 616.09 (1) (a) 2. of the statutes is amended to read:
AB7,8,4
1616.09
(1) (a) 2. Plans authorized under s. 616.06 are subject to s. 610.21, 1977
2stats., s. 610.55, 1977 stats., s. 610.57, 1977 stats., and ss. 628.34 to 628.39, 1977
3stats., to chs. 600, 601, 620, 625, 627 and 645, to ss. 632.72, 632.755,
632.86 632.861 4and 632.87 and to this subchapter except s. 616.08.
AB7,14
5Section 14
. 632.86 of the statutes is repealed.
AB7,15
6Section 15
. 632.861 of the statutes is created to read:
AB7,8,7
7632.861 Prescription drug charges.
(1) Definitions. In this section:
AB7,8,88
(a) “Disability insurance policy” has the meaning given in s. 632.895 (1) (a).
AB7,8,109
(b) “Enrollee” means an individual who is covered under a disability insurance
10policy or a self-insured health plan.
AB7,8,1111
(c) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).
AB7,8,1212
(d) “Prescription drug” has the meaning given in s. 450.01 (20).
AB7,8,1313
(e) “Prescription drug benefit” has the meaning given in s. 632.865 (1) (e).
AB7,8,1414
(f) “Self-insured health plan” has the meaning given in s. 632.85 (1) (c).
AB7,8,22
15(2) Allowing disclosures. (a) A disability insurance policy or self-insured
16health plan that provides a prescription drug benefit may not restrict, directly or
17indirectly, any pharmacy that dispenses a prescription drug to an enrollee in the
18policy or plan from informing, or penalize such pharmacy for informing, an enrollee
19of any differential between the out-of-pocket cost to the enrollee under the policy or
20plan with respect to acquisition of the drug and the amount an individual would pay
21for acquisition of the drug without using any health plan or health insurance
22coverage.
AB7,9,623
(b) A disability insurance policy or self-insured health plan that provides a
24prescription drug benefit shall ensure that any pharmacy benefit manager that
25provides services under a contract with the policy or plan does not, with respect to
1such policy or plan, restrict, directly or indirectly, any pharmacy that dispenses a
2prescription drug to an enrollee in the policy or plan from informing, or penalize such
3pharmacy for informing, an enrollee of any differential between the out-of-pocket
4cost to the enrollee under the policy or plan with respect to acquisition of the drug
5and the amount an individual would pay for acquisition of the drug without using
6any health plan or health insurance coverage.
AB7,9,11
7(3) Cost-sharing limitation. (a) A disability insurance policy or self-insured
8health plan that provides a prescription drug benefit or a pharmacy benefit manager
9that provides services under a contract with a policy or plan may not require an
10enrollee to pay at the point of sale for a covered prescription drug an amount that is
11greater than the lowest of all of the following amounts:
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1. The cost-sharing amount for the prescription drug for the enrollee under the
13policy or plan.
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2. The amount a person would pay for the prescription drug if the enrollee
15purchased the prescription drug at the dispensing pharmacy without using any
16health plan or health insurance coverage.
AB7,9,25
17(4) Drug substitution. (a) Except as provided in par. (b), a disability insurance
18policy that offers a prescription drug benefit, a self-insured health plan that offers
19a prescription drug benefit, or a pharmacy benefit manager acting on behalf of a
20disability insurance policy or self-insured health plan shall provide to an enrollee
21advanced written notice of a formulary change that removes a prescription drug from
22the formulary of the policy or plan or that reassigns a prescription drug to a benefit
23tier for the policy or plan that has a higher deductible, copayment, or coinsurance.
24The advanced written notice of a formulary change under this paragraph shall be
25provided no fewer than 30 days before the expected date of the removal or
1reassignment and shall include information on the procedure for the enrollee to
2request an exception to the formulary change. The policy, plan, or pharmacy benefit
3manager is required to provide the advanced written notice under this paragraph
4only to those enrollees in the policy or plan who are using the drug at the time the
5notification must be sent according to available claims history.
AB7,10,86
(b) 1. A disability insurance policy, self-insured health plan, or pharmacy
7benefit manager is not required to provide advanced written notice under par. (a) if
8the prescription drug that is to be removed or reassigned is any of the following:
AB7,10,99
a. No longer approved by the federal food and drug administration.
AB7,10,1210
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.
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c. Approved by the federal food and drug administration for use without a
14prescription.
AB7,10,2215
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:
AB7,10,2423
a. The same benefit tier from which the prescription drug is being removed or
24reassigned.
AB7,11,2
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.
AB7,11,103
(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:
AB7,11,1211
1. The same benefit tier from which the prescription drug is being removed or
12reassigned.
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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.
AB7,11,2115
(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.
AB7,16
22Section 16
. 632.865 (1) (a) of the statutes is renumbered 632.865 (1) (aw).
AB7,17
23Section 17
. 632.865 (1) (ae) and (ak) of the statutes are created to read:
AB7,11,2424
632.865
(1) (ae) “Health benefit plan” has the meaning given in s. 632.745 (11).
AB7,11,2525
(ak) “Health care provider” has the meaning given in s. 146.81 (1).
AB7,18
1Section
18. 632.865 (1) (c) of the statutes is renumbered 632.865 (1) (c) (intro.)
2and amended to read:
AB7,12,53
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:
AB7,12,6
61. An insurer
or other.
AB7,12,8
73. Another entity that provides prescription drug benefits to residents of this
8state.
AB7,19
9Section 19
. 632.865 (1) (c) 2. of the statutes is created to read:
AB7,12,1010
632.865
(1) (c) 2. A cooperative, as defined in s. 185.01 (2).
AB7,20
11Section 20
. 632.865 (1) (dm) of the statutes is created to read:
AB7,12,1212
632.865
(1) (dm) “Prescription drug" has the meaning given in s. 450.01 (20).
AB7,21
13Section 21
. 632.865 (3) to (7) of the statutes are created to read:
AB7,12,1614
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.
AB7,12,23
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.
AB7,13,3
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:
AB7,13,44
(a) The original claim was submitted fraudulently.
AB7,13,75
(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.
AB7,13,88
(c) The pharmacy services were not rendered by the pharmacist or pharmacy.
AB7,13,109
(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.
AB7,13,1211
(e) The reduction is permitted in a contract between a pharmacy and a
12pharmacy benefit manager and is related to a quality program.
AB7,13,13
13(6) Audits of pharmacies or pharmacists. (a)
Definitions. In this subsection:
AB7,13,1614
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.
AB7,13,2017
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.
AB7,13,2121
3. “Self-insured health plan” has the meaning given in s. 632.85 (1) (c).
AB7,13,2322
(b)
Procedures. An entity conducting an on-site or desk audit of pharmacist
23or pharmacy records shall do all of the following:
AB7,14,3
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.
AB7,14,64
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.
AB7,14,87
3. If the audit involves clinical or professional judgment, conduct the audit by
8or in consultation with a pharmacist licensed in any state.
AB7,14,109
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.
AB7,14,1211
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.
AB7,14,1813
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.
AB7,14,2119
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.
AB7,14,2422
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.
AB7,15,2
1(c)
Results of audit. An entity that has conducted an audit of a pharmacist or
2pharmacy shall do all of the following:
AB7,15,103
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.
AB7,15,1311
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.
AB7,15,1914
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.
AB7,15,2220
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.
AB7,15,2423
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.
AB7,15,2525
6. Exclude dispensing fees from calculations of overpayments.
AB7,16,4
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.
AB7,16,85
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.
AB7,16,149
(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.
AB7,16,1815
(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.
AB7,16,2119
(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.
AB7,16,2422
(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.
AB7,17,3
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.
AB7,17,11
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.
AB7,17,1312
(b) Reports under this subsection shall be considered a trade secret under the
13uniform trade secret act under s. 134.90.
AB7,17,1514
(c) The commissioner may not expand upon the reporting requirement under
15this subsection, except that the commissioner may effectuate this subsection.
AB7,22
16Section 22
. Chapter 633 (title) of the statutes is amended to read:
AB7,17,2017
CHAPTER 633
18
EMPLOYEE BENEFIT PLAN
19
ADMINISTRATORS
AND, PRINCIPALS
,
20
and Pharmacy benefit managers
AB7,23
21Section 23
. 633.01 (1) (intro.) and (c) of the statutes are amended to read:
AB7,17,2522
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:
AB7,18,3
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.
AB7,24
4Section 24
. 633.01 (2r) of the statutes is created to read:
AB7,18,55
633.01
(2r) “Enrollee” has the meaning given in s. 632.861 (1) (b).