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SPONSOR: Sen. Sokola & Rep. Burns
Sens. Sturgeon, Hoffner, Walsh, Hocker, Seigfried; Reps.
Morrison, Romer, Snyder-Hall, Wilson-Anton, Lambert,
Griffith
DELAWARE STATE SENATE
153rd GENERAL ASSEMBLY
SENATE BILL NO. 271
AN ACT TO AMEND TITLE 18 OF THE DELAWARE CODE RELATING TO PHARMACY BENEFITS
MANAGERS.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF DELAWARE:
1 Section 1. Amend Subchapter I, Chapter 33A, Title 18 of the Delaware Code by making deletions as shown by
2 strike through and insertions as shown by underline as follows and by redesignating accordingly:
3 § 3302A. Definitions.
4 For purposes of this subchapter:
5 (4) “Recoupment” means a reduction, offset, adjustment, or other act that lowers or lessens the payment of a claim
6 or any other amount owed to a pharmacy or pharmacist for any reason unrelated to that claim or other amount owed to that
7 pharmacy or pharmacist.
8 (5) “Similarly situated contracted pharmacy” includes any contracted pharmacy that has the capability of
9 complying with standard terms and conditions for a pharmacy type, even if the pharmacy does not operate exclusively as
10 that type of pharmacy.
11 (6) “Wholesale invoice audit” means review of supplier invoices to verify accuracy, compliance with contracted
12 rates, and receipt of goods.
13 § 3304A. Procedure and process for conducting and reporting an audit.
14 (a) Audit procedures. — Unless otherwise prohibited by federal requirements or regulations, any entity conducting
15 a pharmacy audit must adhere to the following procedures:
16 (1) A pharmacy must be given notice 14 days before an initial on-site audit is conducted.
17 (2) An audit that involves clinical or professional judgment must be conducted by or in consultation with
18 a licensed pharmacist.
19 (3) Each pharmacy shall be audited under the same standards and parameters as other similarly situated
20 pharmacies.
21 (4) A pharmacy must be given a range of prescription numbers in advance of no less than 5 business days
22 before the audit.
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23 (5) A pharmacy benefits manager shall provide a pharmacy or pharmacist being audited with a phone
24 number, secured facsimile number, or, if available, access to a secure portal that the pharmacy or pharmacist may
25 use to ask questions regarding the audit.
26 (6) An entity may not initiate an audit of a pharmacy more often than once every 12 months.
27 (b) Audit process. — Unless otherwise prohibited by federal requirements or regulations, for any entity conducting
28 a pharmacy audit all of the following audit items apply:
29 (2) If an entity uses random sampling as a method for selecting a set of claims for examination, the
30 sample size must be appropriate for a statistically reliable sample. The auditing entity shall provide the pharmacy a
31 masked list that provides a prescription number or date range that the auditing entity is seeking to audit. audit no
32 less than 5 business days before an audit.
33 (3) An on-site audit may not take place during the first 5 business days of the month or on a federal
34 holiday unless consented to by the pharmacy.
35 (8) If an entity conducts a wholesale invoice audit, the audit must be limited to verification of purchased
36 inventory specific to the pharmacy claims paid by the plan sponsor or pharmacy benefits manager conducting the
37 audit. Redacted copies of supplier invoices in the pharmacy’s or pharmacist’s possession are acceptable to support
38 the validity of a pharmacy claim.
39 (9) The cost of any audit subject to this subchapter shall be borne by the pharmacy benefits manager
40 conducting the audit. The pharmacy benefits manager may not impose a fee or charge, other than a recoupment or
41 chargeback, or pass costs along related to an audit to the audited pharmacy or pharmacist.
42 § 3309A. Disclosures to plan sponsor.
43 Where contractually required, an auditing entity must provide a copy to the plan sponsor of its all claims that were
44 included in the audit, and any recouped money shall be returned to the plan sponsor.
45 Section 2. Amend Subchapter II, Chapter 33A, Title 18 of the Delaware Code by making deletions as shown by
46 strike through and insertions as shown by underline as follows and by redesignating accordingly:
47 § 3321A. Definitions.
48 As used in For purposes of this subchapter:
49 (7) “Net amount” means the dollar amount that is the result of the invoice price that the pharmacy paid to the
50 supplier for the prescription drug modified as follows, as are attributable to the drug:
51 a. Increased by the dollar amount of all taxes, fees, and other costs.
52 b. Decreased by the dollar amount of all discounts and other cost reductions.
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53 (14) “Similarly situated contracted pharmacy” means as defined in § 3302A of this title.
54 § 3324A. Appeals.
55 (a) (1)a. A pharmacy benefits manager must establish a process by which a contracted pharmacy can appeal the
56 amount of the provider’s reimbursement for a drug subject to maximum allowable cost pricing. that was reimbursed by the
57 pharmacy benefits manager.
58 b. A contracted pharmacy’s representative may take actions and receive notices under this
59 section on behalf of the contracted pharmacy.
60 (2) A contracted pharmacy has 10 40 calendar days after the applicable fill date to appeal a maximum
61 allowable cost reimbursement if the reimbursement for the drug is less than the any of the following:
62 a. The net amount that the network provider paid to the supplier of the drug.
63 b. The reimbursement amount required under § 3372A(7) of this title.
64 (3) A pharmacy benefits manager must respond with notice that the appeal has been denied or granted
65 within 10 calendar days of the contracted pharmacy making the claim for which an appeal has been submitted.
66 (c) (1) If an appeal is denied, the pharmacy benefits manager must provide the a detailed reason for the denial and
67 denial. If the appeal is related to a maximum allowable cost reimbursement, the pharmacy benefits manager must also
68 provide the name and national drug code number of the national or regional wholesalers operating in this State that have the
69 drug in stock at a price below the maximum allowable cost. cost at the time the pharmacy or pharmacist purchased the drug.
70 (2) At the time the pharmacy benefits manager provides the written notice of a final appeal determination
71 under paragraph (c)(1) of this section, the pharmacy benefits manager shall provide notice to the pharmacy of the
72 right to appeal an adverse determination to the Department.
73 (3) The notice under paragraph (c)(2) of this section may be separate from or a part of the written notice
74 of the final determination under paragraph (c)(1) of this section and must, at a minimum, contain all of the
75 following:
76 a. A statement that says “You have the right to appeal the final appeal determination through the
77 Delaware Department of Insurance. All appeals must be filed with the Department within 10 calendar days from
78 the date you receive the pharmacy benefits manager’s final determination.”
79 b. The Department website the pharmacy can use to file an appeal.
80 (d) If the appeal is granted granted, the pharmacy benefits manger manager shall do the following:
81 (1) a. Adjust the maximum allowable cost reimbursement for the drug as of the date of the original claim
82 for payment.
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83 b. Without requiring the appealing pharmacy to reverse and rebill the claims, provide
84 reimbursement for the claim and any subsequent and similar claims under similarly applicable contracts
85 with the pharmacy benefits manager as follows:
86 1. For the original claim, in the first remittance to the pharmacy after the date the appeal
87 was granted.
88 2. For subsequent and similar claims under similarly applicable contracts, in the second
89 remittance to the pharmacy after the date the appeal was granted.
90 (2) For a similarly situated contracted pharmacy in this State, do all of the following:
91 a. Adjust the maximum allowable cost reimbursement for the drug as of the date the appeal was
92 granted.
93 b. Provide notice to the pharmacy or the pharmacy’s contracted agent of all of the following:
94 1. That an appeal was granted.
95 2. That without filing a separate appeal, the pharmacy or the pharmacy’s contracted
96 agent may reverse and rebill a similar claim.
97 (e) A pharmacy benefits manager shall make available provide information on its website information about the
98 appeal process, including all of the following:
99 (1) A telephone number at which the contracted pharmacy may contact the department or office
100 responsible for processing appeals for the pharmacy benefits manager to speak to an individual specifically or
101 leave a message for an individual or office who is responsible for processing appeals.
102 (2) An email address of the department or office responsible for processing appeals to which an
103 individual who is responsible for processing appeals has access.
104 (3) The information required under paragraph (c)(3) of this section.
105 (h) (1) If a pharmacy benefits manager denies an appeal and a contracted pharmacy files an appeal with the
106 Commissioner, the Commissioner shall do all of the following:
107 a. Review the pharmacy benefits manager’s compensation program to ensure that the
108 reimbursement for pharmacy benefits management services paid to the pharmacist or a pharmacy
109 complies with this subchapter and the terms of the contract. the reimbursement requirements under §
110 3372A(7) of this title.
111 b. Based on a determination made by the Commissioner under paragraph (h)(1)a. of this section,
112 do 1 of the following:
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113 1. Deny the appeal.
114 2. Grant the appeal and order the pharmacy benefits manager to pay the claim in
115 accordance with the Commissioner’s findings.
116 (2) All pricing information and data collected by the Commissioner during a review required by
117 paragraph (h)(1) of this section is confidential and not subject to subpoena or the Freedom of Information Act,
118 Chapter 100 of Title 29.
119 (3) The non-prevailing party shall pay the costs incurred by the Department in processing an appeal under
120 this subsection.
121 (4) On request, parties shall provide the Commissioner all mathematical calculations, accounts, records,
122 documents, files, logs, correspondence, or other information necessary to complete the Commissioner’s review of
123 an appeal under this subsection.
124 Section 3. Amend Subchapter III, Chapter 33A, Title 18 of the Delaware Code by making deletions as shown by
125 strike through and insertions as shown by underline as follows:
126 § 3331A. Definitions.
127 For purposes of this subchapter:
128 (3) “Pharmacy benefit benefits manager” means as defined under in § 3302A of this title.
129 § 3333A. Prohibited retaliation due to permitted disclosures.
130 (a) A pharmacy benefits manager may not retaliate against a pharmacist or pharmacy for disclosing information in
131 any proceeding if the pharmacist or pharmacy has reasonable cause to believe that the disclosed information is evidence of
132 a violation of a state or federal law, rule, or regulation. Proceedings under this subsection include information disclosed as
133 follows:
134 (1) To a court.
135 (2) During an administrative investigation or hearing.
136 (3) To a legislative commission or committee.
137 (b) A pharmacy benefits manager may not retaliate against a pharmacist or pharmacy for disclosing information to
138 a government, regulatory, or law enforcement agency, if the pharmacist or pharmacy has reasonable cause to believe that
139 the disclosed information is evidence of a violation of a state or federal law, rule, or regulation.
140 (c) A pharmacist or pharmacy shall, to the extent possible, limit the disclosure of confidential and proprietary
141 information when making a disclosure under subsection (a) or (b) of this section.
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142 (d) Retaliatory actions against a pharmacist or pharmacy include the cancellation or restriction of, the refusal to
143 renew, or the refusal to offer a contract solely because the pharmacy or pharmacist has done 1 or more of the following:
144 (1) Disclosed information under subsection (a) or (b) of this section.
145 (2) Filed complaints with a pharmacy benefits manager.
146 (3) Filed complaints against an insurer or pharmacy benefits manager with the Department.
147 (4) Filed an appeal with the Commissioner under § 3324A(h) of this title.
148 (e) If a contract entered into, amended, extended, or renewed after December 31, 2026, includes a provision that
149 prohibits a disclosure permitted under this section, that provision is against public policy and is void and unenforceable.
150 Section 4. Amend Subchapter IV, Chapter 33A, Title 18 of the Delaware Code by making deletions as shown by
151 strike through and insertions as shown by underline as follows and by redesignating accordingly:
152 § 3335A. Definitions.
153 As used in For purposes of this subchapter:
154 (1) “Chronic or long-term condition” means any of the following:
155 a. A “complex or chronic medical condition” as defined in § 3364(a) of this title.
156 b. A “rare medical condition” as defined in § 3364(a) of this title.
157 (1) “Emergency” (2) “Emergency medical condition” means a situation that will result in loss of life, limb or
158 organ function. as defined in § 3349(e) of this title.
159 (2) (3) “Pharmacy benefit benefits manager” has the meaning given means as defined in § 3302A of this title.
160 § 3336A. Prior authorization of emergency prescriptions.
161 A pharmacy benefit benefits manager may not require prior authorization for coverage of a 72-hour supply of
162 medication that is for a noncontrolled substance in prescribed for an emergency situation. medical condition.
163 § 3337A. Prior authorization of prescriptions for chronic or long-term conditions.
164 (a) A prior authorization form for a prescription medication shall must include a question regarding whether the
165 prescription medication is for a chronic or long-term condition for which the prescription medication may be necessary for
166 the life of the patient.
167 (b) If a prescriber indicates on a prior authorization form that the prescription medication is for a chronic or long-
168 term condition for which the prescription medication may be necessary for the life of the patient, the pharmacy benefit
169 benefits manager may not request a reauthorization for the same prescription medication more frequently than every 12
170 months.
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171 (c) In the same communication in which a pharmacy benefit benefits manager or the pharmacy benefit benefits
172 manager’s agent requests a prior authorization for a prescription medication that has therapeutically equivalent medications
173 that do not require a prior authorization from a prescriber, the pharmacy benefit benefits manager or the pharmacy benefit
174 benefits manager’s agent shall provide the prescriber with a list of alternative prescription medications of the same class
175 and family as the requested medication.
176 (d) Prescribers that utilize e-prescribing shall receive alternate medications from the pharmacy benefit benefits
177 manager for prescription medications that do not require a prior authorization before the completion of the e-prescribing
178 transaction.
179 (e) A pharmacy benefit benefits manager or the pharmacy benefit manager’s agent shall provide alternative
180 medications for therapeutically equivalent medications to the pharmacy that require prior authorization on the National
181 Council for Prescription Drug Programs response transaction to a denied claim for prior authorization.
182 Section 5. Amend Subchapter VI, Chapter 33A, Title 18 of the Delaware Code by making deletions as shown by
183 strike through and insertions as shown by underline as follows and by redesignating accordingly:
184 § 3363A. Reports.
185 (b) A pharmacy benefits manager shall report to the Commissioner on a quarterly basis all of the following
186 information to the Commissioner for each insurer:
187 (1) The On an annual basis, no later than March 31, all of the following:
188 a. The itemized amount of pharmacy benefits manager revenue sources, including professional
189 fees, administrative fees, processing fees, audits, direct and indirect renumeration fees, or any other fees.
190 (2) The aggregate amount of rebates distributed to the appropriate insurer. [Transferred.]
191 (3) The aggregate amount of rebates passed on to insureds of each insurer at the point of sale that reduced
192 the insureds’ applicable deductible, copayment, coinsurance, or other cost-sharing amount. [Transferred.]
193 (4) b.The individual and aggregate amount the insurer paid to the pharmacy benefits manager for
194 pharmacy goods or services provided in this State, itemized by all of the following:
195 a. 1. Pharmacy.
196 b. 2. Product.
197 c. 3, Goods and services.
198 (5) c. The individual and aggregate amount a pharmacy benefits manager paid for pharmacy
199 goods or services provided in this State, itemized by all of the following:
200 a. 1. Pharmacy.
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201 b. 2. Product.
202 c. 3. Goods and services.
203 (2) On an annual basis, all of the following:
204 a. The aggregate amount of the rebates distributed to the appropriate insurer.
205 b. The aggregate amount of the rebates passed on to insureds of each insurer at the point of sale
206 that reduced the insureds’ applicable deductible, copayment, coinsurance, or other cost-sharing amount.
207 (c) The information provided under subsection (b) of this section is confidential and not subject to subpoena or the
208 Freedom of Information Act, Chapter 100 of Title 29.
209 Section 6. Amend Subchapter VII, Chapter 33A, Title 18 of the Delaware Code by making deletions as shown by
210 strike through and insertions as shown by underline as follows and by redesignating accordingly:
211 § 3371A. Definitions.
212 For purposes of this subchapter:
213 (9) “Purchaser” means as defined in § 3351A of this title.
214 (9) (10) “Spread pricing” means the model of prescription drug pricing in which the pharmacy benefits manager
215 charges a health benefit plan purchaser a contracted price for prescription drugs, and the contracted price for the
216 prescription drugs differs from the amount the pharmacy benefits manager directly or indirectly pays the pharmacist or
217 pharmacy for pharmacy goods or services.
218 § 3372A. Prohibited practices.
219 A pharmacy benefits manager or representative of a pharmacy benefits manager may not do any of the following:
220 (7) Pay or reimburse a pharmacy or pharmacist for the ingredient drug product component of pharmacist
221 services less than the national average drug acquisition cost that was in effect on the date of service. or if If the
222 national average drug acquisition cost is unavailable, the wholesale acquisition cost. cost should be applied. The
223 wholesale acquisition cost price must be the price published in effect on the date of service for the drug claim.
224 (10) Amend a contract between a pharmacy benefits manager and a pharmacy or pharmacist without
225 providing at least 60 days’ notice to the affected pharmacy or pharmacist.
226 (11) Require pharmacists to break open unit-of-use items beyond manufacturer recommendations if the
227 only commercially available package size exceeds the minimum days’ supply. Packaging labeled “for single-
228 patient-use only” shall be deemed to be the smallest package size available.
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229 (12) Require a pharmacy to dispense a therapeutically equivalent or therapeutically alternative drug that
230 costs the enrollee more out-of-pocket than the prescribed drug, unless the substitution is made for medical reasons
231 that benefit the enrollee.
232 (13) Transfer or share prescription information containing enrollee-identifiable or prescriber-identifiable
233 data to an affiliated pharmacy for any commercial purpose other than the purposes of facilitating pharmacy
234 reimbursement, formulary compliance, or utilization review.
235 Section 7. This Act applies to contracts between pharmacy benefits managers and pharmacies or pharmacists that
236 are entered into, renewed, amended, or extended after December 31, 2026.
SYNOPSIS
This Act strengthens procedural protections for pharmacies, pharmacists, and consumers related to regulation of a
pharmacy benefits manager by doing all of the following:
Adds definitions for the terms “chronic or long-term condition”, “net amount”, “purchaser”, “recoupment”,
“similarly situated contracted pharmacy”, and “wholesale invoice audit.”
Applies audit notice requirements uniformly and ensures access to an appropriate point of contact. Requires a
pharmacy benefits manager to provide a list of records that the auditing entity seeks to audit at least 5 business days before
an audit. Limits activities to once every 12 months and sets standards for wholesale invoice audits. Ensures audit costs are
borne solely by the pharmacy benefits manager.
Clarifies that a pharmacy can appeal the amount of any reimbursement and that a contracted pharmacy’s
representative can take actions and receive notices related to appeals on behalf of a pharmacy. Extends pharmacies’ ability
to appeal from 10 days to 40 days to account for entities that complete retroactive billing. When an appeal is denied,
requires the parties to provide a detailed reason for the denial and specific information about how the pharmacy can appeal
the denial to the Department of Insurance.
Prohibits retaliation by a pharmacy benefits manager when a pharmacist or pharmacy discloses information to a
government agency or during a proceeding if the person who disclosed the information had reasonable cause to believe that
the disclosed information is evidence of a violation of a state or federal law.
Requires that a pharmacy benefits manager must provide at least 60 days’ notice before amending a contract with
a pharmacy or pharmacist.
Clarifies that the prohibition against spread pricing applies to all purchasers contracting with pharmacy benefits
managers.
Changes the reporting requirements for rebates so that pharmacy benefits managers must file the required reports
annually instead of quarterly. This change will reduce the amount of incorrect or unclear reporting because rebates are
aggregated and reported at the end of the period of time under each contract.
Amends national drug acquisition cost compliance to refer to the date of service. Prohibits pharmacy benefit
managers from unit-of-use requirements inconsistent with smallest package size availability and manufacturer
recommendations. Requires that pharmacy benefit managers may not require pharmacies to dispense therapeutically
equivalent or alternative drugs that cost the enrollee more out of pocket than the prescribed drug except for medical
reasons. Ensures that enrollee-identifiable or prescriber-identifiable information is not transferred to or shared with
affiliated pharmacies for any commercial purpose other than those defined.
This Act also makes technical corrections to conform existing law to the standards of the Delaware Legislative
Drafting Manual.
Author: Senator Sokola
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