reglab/statecodes huggingface dataset:
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33. HEALTH INSURANCE CONTRACTS › Subchapter I. General Provisions › § 3360. Screening of infants and toddlers for developmental delays.

§ 3360. Screening of infants and toddlers for developmental delays.
(a) Definitions. — As used in this section:
(1) “Carrier” means any entity that provides health insurance in this State. For the purposes of this section, “carrier” includes an insurance company, health service corporation, health maintenance organization, and any other entity providing a plan of health insurance or health benefits subject to state insurance regulation. “Carrier” also includes any third-party administrator or other entity that adjusts, administers, or settles claims in connection with health benefit plans.
(2) “Developmental screening” shall mean any developmental screening tool favorably mentioned by the American Academy of Pediatrics Committee on Children with Disabilities in its position paper on “Developmental Surveillance and Screening of Infants and Young Children,” or any program judged by the Department of Health and Social Services to be an equivalent program.
(b) This section shall apply to any health insurance contract that provides coverage for a family member of the insured and is delivered by a carrier or issued by a carrier for delivery in the State.
(c) This section shall not apply to policies that exclusively cover:
(1) Hospital confinement indemnity;
(2) Disability income;
(3) Accident only;
(4) Long-term care;
(5) Medicare supplement;
(6) Specified disease indemnity; or
(7) Sickness or bodily injury or death by accident, or both.
(d) Every health insurance policy covered by this section shall entitle children covered by the policy to receive developmental screenings at ages 9 months, 18 months, and 30 months.
77 Del. Laws, c. 207, §  1;  80 Del. Laws, c. 310, § 1;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33. HEALTH INSURANCE CONTRACTS › Subchapter I. General Provisions › § 3365. School-based health centers.

§ 3365. School-based health centers.
(a) For purposes of this section, a school-based health center (SBHC) is a health clinic that:
(1) Is located in or near a school facility;
(2) Is organized through school and health provider relationships;
(3) Provides through licensed professionals primary health services to children, including comprehensive health assessments, diagnosis, and treatment of minor, acute, and chronic medical conditions, referrals to and follow-up for specialty care and oral and vision health services, mental health and substance use disorder assessments, crisis intervention, counseling, treatment, and referral to a continuum of mental health and substance abuse services including emergency psychiatric care, community support programs, inpatient care, and outpatient programs; and
(4) Is recognized by the State pursuant to relevant regulations and law.
(b) The Delaware Division of Public Health (DPH) shall have sole authority to determine whether a facility is an SBHC as defined in subsection (a) of this section.
(c) Except as noted herein, benefits provided under insurance contracts delivered, issued for delivery, or renewed in this State shall reimburse SBHCs for covered services provided by SBHCs as if those services were provided by a network provider under the relevant contract of insurance. In the absence of an agreement between a carrier and an SBHC on reimbursement, reimbursement for such services shall be at the rate established by the Division of Medicaid and Medical Assistance for those services. Any insurance contract term purporting to exclude otherwise covered services on the basis that they are performed by an SBHC shall be void except as specifically permitted under this chapter.
(d) If DPH has approved an SBHC, that approval shall be deemed sufficient to meet the carrier's standards for inclusion in its network or for being eligible for payment by the carrier.
(e) SBHCs shall not charge co-pays or any other out-of-pocket fees to students for use of SBHC services. Insurance carriers shall not incur any additional financial liability by virtue of this subsection.
(f) The Delaware DPH, in coordination with the State's SBHCs, insurance carriers, and the Department of Insurance, shall issue regulations to ensure that SBHCs are properly integrated into the State's spectrum of health-care providers that provide covered services to youth. These regulations shall include, but are not limited to:
(1) Regulations governing reporting to and interaction with students' primary care providers; and
(2) Regulations regarding promotion of vaccinations among student users of SBHCs.
(g) Nothing in this chapter shall prevent the enforceability of an agreement negotiated between an SBHC and an insurance carrier governing claims submission, reimbursement, quality standards, credentialing and similar matters, provided, however, that in the absence of such agreement the terms of this chapter shall govern.
78 Del. Laws, c. 276, §  1;  80 Del. Laws, c. 310, § 1;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33. HEALTH INSURANCE CONTRACTS › Subchapter I. General Provisions › § 3367. Payment for emergency medical services.

§ 3367. Payment for emergency medical services.
(a) As used in this section:
(1) “Ambulance” shall have the same definition set forth in § 9702 of Title 16.
(2) “Basic life support” shall have the same definition set forth in § 9702 of Title 16.
(3) “Emergency medical services provider agency” shall have the same definition set forth in § 9802 of Title 16.
(4) “Volunteer fire company” shall mean the duly organized volunteer fire companies in the State.
(b) Notwithstanding any provision precluding an assignment of benefits in any individual health insurance policy, contract, certificate or plan, delivered or issued for delivery in this State by any insurer, health service corporation, or health maintenance organization, when a volunteer fire company or other emergency medical services provider agency certified by the Delaware State Fire Prevention Commission renders covered emergency medical services or supplies, including but not limited to basic life support and ambulance service, any payment or reimbursement made by an insurer, health service corporation or health maintenance organization for such covered emergency medical services or supplies shall be paid directly to the volunteer fire company or other certified emergency medical services provider agency, or their designee, without regard to whether a contract exists between the volunteer fire company or certified emergency medical services provider agency and the insurer, health service corporation or health maintenance organization, and otherwise without regard to whether the volunteer fire company or emergency medical services provider agency is a part of any network maintained by the insurer, health service corporation or health maintenance organization.
(c) The limitations on balance billing provided in § 3348 of this title shall not apply to billing for emergency medical services within the scope of this section provided by volunteer fire companies or emergency medical services provider agencies certified by the Delaware State Fire Prevention Commission.
(d) This section shall apply to all policies, contracts, certificates or plans issued, renewed, modified, altered, amended or reissued on or after July 1, 2013.
(e) Nothing in this section should apply to supplemental health insurance policies that do not provide expense or reimbursement coverage for emergency medical services, basic life support or ambulance services.
79 Del. Laws, c. 76, §  1;  80 Del. Laws, c. 310, § 1;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33. HEALTH INSURANCE CONTRACTS › Subchapter I. General Provisions › § 3368. No lifetime or annual limits [For application of this section, see 79 Del. Laws, c. 99, § 19].

§ 3368. No lifetime or annual limits [For application of this section, see 79 Del. Laws, c. 99, § 19].
(a) (1) Except as provided in subsection (b) of this section, a health insurance issuer offering group or individual health insurance coverage may not establish any lifetime limit on the dollar amount of benefits for any individual.
(2) a. Except as provided in paragraph (a)(2)b., subsections (b) and (d) of this section, a health insurance issuer offering group or individual health insurance coverage may not establish any annual limit on the dollar amount of benefits for any individual.
b. A health flexible spending arrangement (as defined in § 106(c)(2) of the Internal Revenue Code) [26 U.S.C. § 106(c)(2)] is not subject to the requirement in paragraph (a)(2)a. of this section.
(b) (1) The rules of this section do not prevent a health insurance issuer offering group or individual health insurance coverage from placing annual or lifetime dollar limits with respect to any individual on specific covered benefits that are not essential health benefits to the extent that such limits are otherwise permitted under applicable federal or state law.
(2) The rules of this section do not prevent a health insurance issuer offering group or individual health insurance coverage from excluding all benefits for a condition. However, if any benefits are provided for a condition, then the requirements of this section apply. Other requirements of federal or state law may require coverage of certain benefits.
(c) The term “essential health benefits” as used in this section means essential health benefits under § 1302(b) of the Patient Protection and Affordable Care Act [42 U.S.C. § 18022(b)], as the law and its implementing regulations were in effect on January 1, 2018; Delaware law; and applicable state regulations.
(d) (1) With respect to policy years beginning prior to January 1, 2014, a health insurance issuer offering group or individual health insurance coverage may establish, for any individual, an annual limit on the dollar amount of benefits that are essential health benefits, provided the limit is no less than the following amounts:
a. For a policy year beginning on or after September 23, 2010, but before September 23, 2011, $750,000.
b. For a policy year beginning on or after September 23, 2011, but before September 23, 2012, $1,250,000.
c. For policy years beginning on or after September 23, 2012, but before January 1, 2014, $2,000,000.
(2) In determining whether an individual has received benefits that meet or exceed the applicable amount described in paragraph (d)(1) of this section, an issuer must take into account only essential health benefits.
79 Del. Laws, c. 99, §  4;  80 Del. Laws, c. 310, § 1;  82 Del. Laws, c. 186, § 2;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33. HEALTH INSURANCE CONTRACTS › Subchapter I. General Provisions › § 3369. Notification and reasons for cancellation or nonrenewal [For application of this section, see 79 Del. Laws, c. 390, § 8].

§ 3369. Notification and reasons for cancellation or nonrenewal [For application of this section, see 79 Del. Laws, c. 390, § 8].
A notice of cancellation or nonrenewal of health insurance coverage by an insurer due to nonpayment of premiums shall be in writing, shall be delivered to the named policyholder or mailed to the named policyholder at the last known address of the named policyholder, shall state the effective date of the cancellation or nonrenewal and shall be accompanied by a written explanation of the specific reasons for the cancellation or nonrenewal. Proof of mailing of such cancellation or nonrenewal notice shall be retained by the insurer for a period of not less than 1 year. This section shall not apply to any policy issued under the Delaware Healthy Children Program or any long-term care policy where notice provisions regarding cancellations or nonrenewals are specifically addressed elsewhere in this title or in regulations promulgated thereunder.
79 Del. Laws, c. 390, §  3;  80 Del. Laws, c. 310, § 1;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33. HEALTH INSURANCE CONTRACTS › Subchapter I. General Provisions › § 3370B. Coverage for treatment of pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections and pediatric acute onset neuropsychiatric syndrome.

§ 3370B. Coverage for treatment of pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections and pediatric acute onset neuropsychiatric syndrome.
(a) All individual health insurance policies, contracts, or certificates that are delivered, issued for delivery, renewed, extended, or modified in this State by any health insurer, health service corporation, or health maintenance organization shall provide coverage for treatment of pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections and pediatric acute onset neuropsychiatric syndrome, including the use of intravenous immunoglobulin therapy.
(b) At any time that the State determines it is required under federal law to defray the cost of any coverage for pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections and pediatric acute onset neuropsychiatric syndrome required under subsection (a) of this section, the requirements under subsection (a) of this section are inoperative and the State may not assume any obligation for the cost of coverage for pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections and pediatric acute onset neuropsychiatric syndrome.
81 Del. Laws, c. 400, § 1;  84 Del. Laws, c. 233, § 38;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33. HEALTH INSURANCE CONTRACTS › Subchapter I. General Provisions › § 3370C. Time of submitting claim for reimbursement.

§ 3370C. Time of submitting claim for reimbursement.
(a) For purposes of this section:
(1) “Carrier” means any entity that provides health insurance in this State. “Carrier” includes an insurance company, health service corporation, health maintenance organization, and any other entity providing a plan of health insurance or health benefits subject to state insurance regulation. “Carrier” also includes any third-party administrator or other entity that adjusts, administers, or settles claims in connection with health benefit plans.
(2) “Carrier” does not mean an entity that provides a plan of health insurance or health benefits designed for issuance to persons eligible for coverage under Titles XVIII, XIX, and XXI of the Social Security Act (42 U.S.C. §§ 1395 et seq., 1396 et seq. and 1397 et seq.), known as Medicare, Medicaid, or any other similar coverage under state or federal governmental plans.
(b) Regardless of network status, a carrier shall permit a provider a minimum of 180 days from the date a covered service is rendered to submit a claim for reimbursement. Any contract between a carrier and provider that prohibits a provider from submitting a claim beyond the minimum time limit required under this section shall not be deemed a violation of this section.
82 Del. Laws, c. 111, § 3;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33. HEALTH INSURANCE CONTRACTS › Subchapter I. General Provisions › § 3370D. Coverage for epinephrine autoinjectors.

§ 3370D. Coverage for epinephrine autoinjectors.
(a) For purposes of this section, “epinephrine autoinjector” means a single-use device used for the automatic injection of a premeasured dose of epinephrine into the human body.
(b) All individual health insurance policies, contracts, or certificates that are delivered, issued for delivery, renewed, extended, or modified in this State shall provide coverage for medically-necessary epinephrine autoinjectors by including at least 1 formulation of epinephrine autoinjectors on the lowest tier of the drug formulary developed and maintained by the carrier.
(c) Nothing in this section prevents the operation of a policy provision required by this section as a deductible, coinsurance, allowable charge limitation, coordination of benefits, or a provision restricting coverage to services by a licensed, certified, or carrier-approved provider or facility.
(d) (1) For individuals who are 18 years of age or under, this section applies to all policies, contracts, or certificates issued, renewed, modified, altered, amended, or reissued after December 31, 2021.
(2) For individuals who are more than 18 years of age, this section applies to all policies, contracts, or certificates issued, renewed, modified, altered, amended, or reissued after December 31, 2024.
(e) This section does not apply to accident-only, specified disease, hospital indemnity, Medicare supplement, long-term care, disability income, or other limited benefit health insurance policies.
83 Del. Laws, c. 42, § 1;  83 Del. Laws, c. 283, § 26;  84 Del. Laws, c. 36, § 1;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33. HEALTH INSURANCE CONTRACTS › Subchapter II. Pre-Authorization Transparency › § 3372. . . Disclosure and review of pre-authorization requirements.

§ 3372. . Disclosure and review of pre-authorization requirements.
(a) A utilization review entity shall make any current pre-authorization requirements and restrictions readily accessible on its website and in written or electronic form upon request for covered persons, health-care providers, and others with access to the website. Information from a utilization review entity that is not an insurer, health-benefit plan, or health-service corporation shall make this information available at an electronic pre-authorization portal that is accessible in real time. Requirements shall be described in detail but also in clear, easily-understandable language. Clinical criteria shall be described in language easily understandable by a health-care provider practicing in the same clinical area.
(b) If an insurer, health-benefit plan, or health-service corporation intends either to implement a new pre-authorization requirement or restriction, or amend an existing requirement or restriction, they shall ensure that the new or amended requirement is not implemented unless their website has been updated to reflect the new or amended requirement or restriction. This shall not extend to expansion of coverage for new health-care services.
(c) If an insurer, health-benefit plan, or health-service corporation intends either to implement a new pre-authorization requirement or restriction, or amend an existing requirement or restriction, they shall provide covered persons who are currently authorized by the utilization review entity for coverage of the affected health-care service and all contracted health-care providers who provide affected health-care service or services of written notice of the new or amended requirement or amendment no less than 60 days before the requirement or restriction is implemented. Such notice may be delivered electronically or by other means.
(d) Insurers, health-benefit plans, and health-service corporations utilizing pre-authorization shall report de-identified statistics regarding pre-authorization approvals, denials, and appeals to the Delaware Health Information Network in a format and frequency, no less than twice annually, of the Delaware Health Information Network's request. The Department may also request this data at any time. The statistics shall include, but may be expanded upon or further delineated by regulation, categories for all of the following:
(1) For denials, the aggregated reasons for denials such as, but not limited to, medical necessity or incomplete pre-authorization submission.
(2) For appeals:
a. Practitioner specialty;
b. Medication, diagnostic test, or diagnostic procedure;
c. Indication offered;
d. Reason for underlying denial; and
e. Number of denials overturned upon appeal.
80 Del. Laws, c. 310, § 1;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33. HEALTH INSURANCE CONTRACTS › Subchapter II. Pre-Authorization Transparency › § 3373. . . Utilization review entity's obligations with respect to pre-authorizations in nonemergency circumstances.

§ 3373. . Utilization review entity's obligations with respect to pre-authorizations in nonemergency circumstances.
(a) If a utilization review entity requires pre-authorization of a pharmaceutical, the utilization review entity must complete its process or render an adverse determination and notify the covered person's health-care provider within 2 business days of obtaining a clean pre-authorization or of using services described in § 3377 of this title.
(b) If a utilization review entity requires pre-authorization of a health-care service, the utilization review entity must grant a pre-authorization or issue an adverse determination and notify the covered person's health-care provider of the determination within 8 business days of receipt of a clean pre-authorization not submitted through electronic pre-authorization. For purposes of this subsection, a clean pre-authorization includes the results of any face-to-face clinical evaluation or second opinion that may be required.
(c) If a utilization review entity requires pre-authorization of a health-care service, the utilization review entity must grant a pre-authorization or issue an adverse determination and notify the covered person's health-care provider of the determination within 5 business days of receipt of a clean pre-authorization through electronic pre-authorization. For purposes of this subsection, a clean pre-authorization includes the results of any face-to-face clinical evaluation or second opinion that may be required.
80 Del. Laws, c. 310, § 1;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33. HEALTH INSURANCE CONTRACTS › Subchapter II. Pre-Authorization Transparency › § 3374. Utilization review entity's obligations with respect to pre-authorization concerning emergency health-care services.

§ 3374. Utilization review entity's obligations with respect to pre-authorization concerning emergency health-care services.
A utilization review entity must follow all emergency procedures and mandates as delineated in §§ 3349 and 3565 of this title.
80 Del. Laws, c. 310, § 1;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33. HEALTH INSURANCE CONTRACTS › Subchapter II. Pre-Authorization Transparency › § 3375. Retrospective denial.

§ 3375. Retrospective denial.
The utilization review entity may not revoke, limit, condition or restrict a pre-authorization on ground of medical necessity after the date the health-care provider received the pre-authorization. Any language attempting to disclaim payment for services on the basis of changes to medical necessity that have been pre-authorized and delivered while under coverage shall be null and void. A proper notification of policy changes validly delivered as per § 3372 of this title may void a pre-authorization if received after pre-authorization but before delivery of the service.
80 Del. Laws, c. 310, § 1;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33. HEALTH INSURANCE CONTRACTS › Subchapter II. Pre-Authorization Transparency › § 3376. Length of pre-authorization.

§ 3376. Length of pre-authorization.
(a) A pre-authorization for pharmaceuticals shall be valid for 1 year from the date the health-care provider receives the pre-authorization, subject to confirmation of continued coverage and eligibility and to policy changes validly delivered as per § 3372 of this title and except as otherwise set by evidence-based treatment protocol.
(b) A pre-authorization for a health-care service shall be valid for a period of time that is reasonable and customary for the specific service, but no less than 60 days, from the date the health-care provider receives the pre-authorization, subject to confirmation of continued coverage and eligibility and to policy changes validly delivered as per § 3372 of this title.
80 Del. Laws, c. 310, § 1;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33. HEALTH INSURANCE CONTRACTS › Subchapter II. Pre-Authorization Transparency › § 3377. Electronic standards for pharmaceutical pre-authorization.

§ 3377. Electronic standards for pharmaceutical pre-authorization.
No later than January 1, 2018, the insurer must accept and respond to pre-authorization requests under the pharmacy benefit through a secure electronic transmission using the NCPDP SCRIPT standard ePA transactions. Facsimile, proprietary payer portals, and electronic forms shall not be considered electronic transmission.
80 Del. Laws, c. 310, § 1;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33. HEALTH INSURANCE CONTRACTS › Subchapter II. Pre-Authorization Transparency › § 3378. Health-care services deemed preauthorized if a utilization review entity fails to comply with the requirements of this subchapter.

§ 3378. Health-care services deemed preauthorized if a utilization review entity fails to comply with the requirements of this subchapter.
Any failure by a utilization review entity to comply with the deadlines and other requirements specified in this subchapter will result in any health-care services subject to review to be automatically deemed preauthorized.
80 Del. Laws, c. 310, § 1;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33. HEALTH INSURANCE CONTRACTS › Subchapter II. Pre-Authorization Transparency › § 3379. Waiver prohibited.

§ 3379. Waiver prohibited.
The provisions of this subchapter cannot be waived by contract issued or renewed after January 1, 2017. Any contractual arrangement in conflict with the provisions of this subchapter or that purports to waive any requirements of this subchapter is null and void.
80 Del. Laws, c. 310, § 1;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33. HEALTH INSURANCE CONTRACTS › Subchapter II. Pre-Authorization Transparency › § 3380. Exemptions.

§ 3380. Exemptions.
This subchapter shall not apply to policies or contracts designed for issuance to persons eligible for coverage under Titles XVIII, XIX, and XXI of the Social Security Act [42 U.S.C. § 1395 et seq., § 1396 et seq. and § 1397aa. et seq.], known as Medicare, Medicaid, or any other similar coverage under state or federal governmental plans.
80 Del. Laws, c. 310, § 1;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33A. Pharmacy Benefits Managers [For application of this chapter, see 80 Del. Laws, c. 245, §? 2] › Subchapter I. Pharmacy Audit Integrity Program [For application of this subchapter, see 80 Del. Laws, c. 245, § 2] › § 3301A. Pharmacy Audit Integrity Program [For application of this section, see 80 Del. Laws, c. 245, § 2].

§ 3301A. Pharmacy Audit Integrity Program [For application of this section, see 80 Del. Laws, c. 245, § 2].
The Pharmacy Audit Integrity Program is established to provide standards for an audit of pharmacy records carried out by a pharmacy benefits manager or any entity that represents pharmacy benefits managers.
80 Del. Laws, c. 65, §  1;  80 Del. Laws, c. 245, § 1;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33A. Pharmacy Benefits Managers [For application of this chapter, see 80 Del. Laws, c. 245, §? 2] › Subchapter I. Pharmacy Audit Integrity Program [For application of this subchapter, see 80 Del. Laws, c. 245, § 2] › § 3302A. Definitions [For application of this section, see 80 Del. Laws, c. 245, § 2; and 83 Del. Laws, c. 256, § 15].

§ 3302A. Definitions [For application of this section, see 80 Del. Laws, c. 245, § 2; and 83 Del. Laws, c. 256, § 15].
For purposes of this subchapter:
(1) “Entity” means a pharmacy benefits manager or any person or organization that represents these companies, groups, or organizations.
(2) “Pharmacy benefits manager” or “PBM” means an entity that contracts with pharmacists or pharmacies on behalf of a person to do any of the following:
a. Process claims for prescription drugs or medical supplies or provide retail network management for pharmacies or pharmacists.
b. Pay pharmacies or pharmacists for prescription drugs or medical supplies.
c. Negotiate rebates with manufacturers for drugs paid for or procured as described in this chapter.
(3) “Plan sponsor” means as defined under § 4405 of this title.
80 Del. Laws, c. 65, §  1;  80 Del. Laws, c. 245, § 1;  83 Del. Laws, c. 256, § 1;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33A. Pharmacy Benefits Managers [For application of this chapter, see 80 Del. Laws, c. 245, §? 2] › Subchapter I. Pharmacy Audit Integrity Program [For application of this subchapter, see 80 Del. Laws, c. 245, § 2] › § 3303A. Pharmacy benefit manager contract [For application of this section, see 80 Del. Laws, c. 245, §  2].

§ 3303A. Pharmacy benefit manager contract [For application of this section, see 80 Del. Laws, c. 245, §  2].
An amendment to pharmacy audit terms in a contract between a PBM and a pharmacy must be disclosed to the pharmacy at least 60 days prior to the effective date of the proposed change.
80 Del. Laws, c. 65, §  1;  80 Del. Laws, c. 245, § 1;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33A. Pharmacy Benefits Managers [For application of this chapter, see 80 Del. Laws, c. 245, §? 2] › Subchapter I. Pharmacy Audit Integrity Program [For application of this subchapter, see 80 Del. Laws, c. 245, § 2] › § 3305A. Requirements for recoupment or chargeback [For application of this section, see 80 Del. Laws, c. 245, §  2].

§ 3305A. Requirements for recoupment or chargeback [For application of this section, see 80 Del. Laws, c. 245, §  2].
For recoupment or chargeback, the following criteria apply:
(1) Audit parameters must consider consumer-oriented parameters based on manufacturer listings.
(2) The reimbursable cost for a compounded medication shall be reflective of the ingredients, supplies and professional time reasonably required to create the finished product.
(3) A finding of overpayment or underpayment must be based on the actual overpayment or underpayment and not a projection based on the number of patients served having a similar diagnosis or on the number of similar orders or refills for similar drugs.
(4) The entity conducting the audit shall not use extrapolation in calculating the recoupment or penalties for audits unless required by state or federal law or regulations.
(5) Calculations of overpayments must not include dispensing fees unless a prescription was not actually dispensed, the prescriber denied authorization, the prescription dispensed was a medication error by the pharmacy, or the identified overpayment is solely based on an extra dispensing fee.
(6) An entity may not consider any clerical or record-keeping error, such as a typographical error, scrivener's error, or computer error regarding a required document or record as fraud, however such errors may be subject to recoupment.
(7) In the case of errors that have no actual financial harm to the patient or plan, the PBM must not assess any chargebacks. Errors that are a result of the pharmacy failing to comply with a formal corrective action plan may be subject to recovery.
(8) Interest may not accrue during the audit period for either party, beginning with the notice of the audit and ending with the final audit report.
80 Del. Laws, c. 65, §  1;  80 Del. Laws, c. 245, § 1;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33A. Pharmacy Benefits Managers [For application of this chapter, see 80 Del. Laws, c. 245, §? 2] › Subchapter I. Pharmacy Audit Integrity Program [For application of this subchapter, see 80 Del. Laws, c. 245, § 2] › § 3306A. Documentation [For application of this section, see 80 Del. Laws, c. 245, §  2].

§ 3306A. Documentation [For application of this section, see 80 Del. Laws, c. 245, §  2].
(a) To validate the pharmacy record and delivery, the pharmacy may use authentic and verifiable statements or records including medication administration records of a nursing home, assisted living facility, hospital, physician, or other authorized practitioner or additional audit documentation parameters located in the provider manual.
(b) Any legal prescription that meets the requirements in this subchapter may be used to validate claims in connection with prescriptions, refills, or changes in prescriptions, including medication administration records, faxes, e-prescriptions, or documented telephone calls from the prescriber or the prescriber's agents.
80 Del. Laws, c. 65, §  1;  80 Del. Laws, c. 245, § 1;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33A. Pharmacy Benefits Managers [For application of this chapter, see 80 Del. Laws, c. 245, §? 2] › Subchapter I. Pharmacy Audit Integrity Program [For application of this subchapter, see 80 Del. Laws, c. 245, § 2] › § 3307A. Appeals process [For application of this section, see 80 Del. Laws, c. 245, §  2].

§ 3307A. Appeals process [For application of this section, see 80 Del. Laws, c. 245, §  2].
The entity conducting the audit must establish a written appeals process which must include appeals of preliminary reports and final reports.
80 Del. Laws, c. 65, §  1;  80 Del. Laws, c. 245, § 1;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33A. Pharmacy Benefits Managers [For application of this chapter, see 80 Del. Laws, c. 245, §? 2] › Subchapter I. Pharmacy Audit Integrity Program [For application of this subchapter, see 80 Del. Laws, c. 245, § 2] › § 3308A. Audit information and reports [For application of this section, see 80 Del. Laws, c. 245, §  2].

§ 3308A. Audit information and reports [For application of this section, see 80 Del. Laws, c. 245, §  2].
(a) A preliminary audit report must be delivered to the pharmacy within 30 days after the conclusion of the audit. The preliminary audit report shall contain claim level information for any discrepancy and an estimated recovery amount.
(b) A pharmacy must be allowed at least 45 days following receipt of the preliminary audit to provide documentation to address any discrepancy found in the audit.
(c) A final audit report must be delivered to the pharmacy within 120 days after receipt of the preliminary audit report or final appeal, whichever is later.
(d) An entity shall remit any money due to a pharmacy or pharmacist as a result of an underpayment of a claim within 45 days after the appeals process has been exhausted and the final audit report has been issued.
80 Del. Laws, c. 65, §  1;  80 Del. Laws, c. 245, § 1;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33A. Pharmacy Benefits Managers [For application of this chapter, see 80 Del. Laws, c. 245, §? 2] › Subchapter I. Pharmacy Audit Integrity Program [For application of this subchapter, see 80 Del. Laws, c. 245, § 2] › § 3309A. Disclosures to plan sponsor [For application of this section, see 80 Del. Laws, c. 245, §  2].

§ 3309A. Disclosures to plan sponsor [For application of this section, see 80 Del. Laws, c. 245, §  2].
Where contractually required, an auditing entity must provide a copy to the plan sponsor of its claims that were included in the audit, and any recouped money shall be returned to the plan sponsor.
80 Del. Laws, c. 65, §  1;  80 Del. Laws, c. 245, § 1;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33A. Pharmacy Benefits Managers [For application of this chapter, see 80 Del. Laws, c. 245, §? 2] › Subchapter I. Pharmacy Audit Integrity Program [For application of this subchapter, see 80 Del. Laws, c. 245, § 2] › § 3310A. Applicability of other laws and regulations [For application of this section, see 80 Del. Laws, c. 245, § 2].

§ 3310A. Applicability of other laws and regulations [For application of this section, see 80 Del. Laws, c. 245, § 2].
This subchapter does not apply to any investigative audit that involves suspected fraud, wilful misrepresentation, abuse, or any audit completed by the State.
80 Del. Laws, c. 65, §  1;  80 Del. Laws, c. 245, § 1;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33A. Pharmacy Benefits Managers [For application of this chapter, see 80 Del. Laws, c. 245, §? 2] › Subchapter II. Maximum Allowable Cost Pricing for Prescription Drugs and Reimbursement for and Provision of Pharmacy Goods or Services [For application of this subchapter, see 80 Del. Laws, c. 245, § 2; and 83 Del. Laws, c. 256, § 15] › § 3321A. Definitions [For application of this section, see 80 Del. Laws, c. 245, § 2].

§ 3321A. Definitions [For application of this section, see 80 Del. Laws, c. 245, § 2].
As used in this subchapter:
(1) “Claim” means a request from a pharmacy or pharmacist to be reimbursed for the cost of filling or refilling a prescription for a drug or for providing a medical supply or device.
(2) “Contracted pharmacy” means a pharmacy that participates in the network of a pharmacy benefits manager through a contract with a pharmacy benefits manager, a pharmacy services administration organization, or a group purchasing organization.
(3) “Drug shortage list” means a list of drug products listed on the federal Food and Drug Administration's Drug Shortages website.
(4) “Insurer” means any entity that provides health insurance coverage in this State as defined in § 903 of this title.
(5) “Maximum allowable cost” means the maximum amount that a pharmacy benefits manager will reimburse a pharmacist or pharmacy for the cost of a multi-sourced drug, medical product, or device.
(6) “Maximum allowable cost list” means the multi-source generic drugs, medical products, and devices for which a maximum allowable cost has been established by a pharmacy benefits manager or a purchaser.
(7) “Network providers” means those pharmacists and pharmacies who provide covered health-care services or supplies to an insured or a member pursuant to a contract with an insurer or pharmacy benefits manager.
(8) “Pharmacist” means as defined under § 2502 of Title 24.
(9) “Pharmacy” means as defined under § 2502 of Title 24.
(10) “Pharmacy benefits management services” means as defined under § 3351A of this title.
(11) “Pharmacy benefits manager” means as defined under § 3302A of this title.
(12) “Purchaser” means as defined under § 3351A of this title.
80 Del. Laws, c. 245, § 1;  82 Del. Laws, c. 115, § 1;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33A. Pharmacy Benefits Managers [For application of this chapter, see 80 Del. Laws, c. 245, §? 2] › Subchapter II. Maximum Allowable Cost Pricing for Prescription Drugs and Reimbursement for and Provision of Pharmacy Goods or Services [For application of this subchapter, see 80 Del. Laws, c. 245, § 2; and 83 Del. Laws, c. 256, § 15] › § 3322A. Exclusions [For application of this section, see 80 Del. Laws, c. 245, § 2].

§ 3322A. Exclusions [For application of this section, see 80 Del. Laws, c. 245, § 2].
This subchapter does not apply to the Department of Health and Human Services in the performance of its duties in administering fee-for-service Medicaid under Titles XIX and XXI of the Social Security Act [42 U.S.C. §§ 1396 et seq., 1397aa et seq.].
80 Del. Laws, c. 245, § 1;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33A. Pharmacy Benefits Managers [For application of this chapter, see 80 Del. Laws, c. 245, §? 2] › Subchapter II. Maximum Allowable Cost Pricing for Prescription Drugs and Reimbursement for and Provision of Pharmacy Goods or Services [For application of this subchapter, see 80 Del. Laws, c. 245, § 2; and 83 Del. Laws, c. 256, § 15] › § 3325A. Reimbursement for and provision of pharmacy goods or services For application of this section, see 83 Del. Laws, c. 256, § 15].

§ 3325A. Reimbursement for and provision of pharmacy goods or services For application of this section, see 83 Del. Laws, c. 256, § 15].
(a) For purposes of this section:
(1) “Affiliate” means a pharmacy or pharmacist that directly or indirectly, through 1 or more intermediaries, owns or controls, is owned or controlled by, or is under common ownership or control with, a pharmacy benefits manager.
(2) “Pharmaceutical wholesaler” means a person that sells and distributes a pharmaceutical product and offers regular and private delivery to a pharmacy.
(3) “Pharmacy acquisition cost” means the amount that a pharmaceutical wholesaler charges for a pharmaceutical product as listed on the pharmacy's billing invoice.
(4) “Pharmacy goods or services” means 1 or more of the following provided by a pharmacist or pharmacy:
a. A single-sourced drug, multi-sourced drug, or compounded drug.
b. A medical product.
c. A medical device.
d. A service.
(b) A pharmacy benefits manager may not reimburse a pharmacist or pharmacy for pharmacy goods or services in an amount less than the amount the pharmacy benefits manager reimburses itself or an affiliate for the same pharmacy goods or services.
(c) If the amount reimbursed by a pharmacy benefits manager for pharmacy goods or services is less than the pharmacy acquisition cost for the same pharmacy goods or services, a pharmacist or pharmacy may decline to provide the pharmacy goods or services to a patient.
(d) A pharmacist or pharmacy acting under subsection (c) of this section shall do all of the following:
(1) Inform the patient that the pharmacist or pharmacy has made the decision not to provide pharmacy goods or services to the patient under subsection (c) of this section because of the costs associated with providing the pharmacy goods or services.
(2) Provide the patient with a list of pharmacies in the area that may provide the pharmacy goods or services.
83 Del. Laws, c. 256, § 5;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33A. Pharmacy Benefits Managers [For application of this chapter, see 80 Del. Laws, c. 245, §? 2] › Subchapter III. Permitted Disclosures Related to Prescription Drugs [For application of this subchapter, see 81 Del. Laws, c. 378, § 2]. › § 3331A. Definitions [For application of this section, see 81 Del. Laws, c. 378, § 2; and 83 Del. Laws, c. 256, § 15].

§ 3331A. Definitions [For application of this section, see 81 Del. Laws, c. 378, § 2; and 83 Del. Laws, c. 256, § 15].
For purposes of this subchapter:
(1) “Pharmacist” means as defined in § 2502 of Title 24.
(2) “Pharmacy” means as defined in § 2502 of Title 24.
(3) “Pharmacy benefit manager” means as defined under § 3302A of this title.
(4) “Substitute” means as defined in § 2502 of Title 24.
81 Del. Laws, c. 378, § 1;  83 Del. Laws, c. 256, § 6;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33A. Pharmacy Benefits Managers [For application of this chapter, see 80 Del. Laws, c. 245, §? 2] › Subchapter III. Permitted Disclosures Related to Prescription Drugs [For application of this subchapter, see 81 Del. Laws, c. 378, § 2]. › § 3332A. Permitted disclosures related to prescription drugs [For application of this section, see 81 Del. Laws, c. 378, § 2; and 81 Del. Laws, c. 256, §  15].

§ 3332A. Permitted disclosures related to prescription drugs [For application of this section, see 81 Del. Laws, c. 378, § 2; and 81 Del. Laws, c. 256, §  15].
A contract between a pharmacy benefits manager and a pharmacy may not prohibit a pharmacy or pharmacist from doing any of the following:
(1) Providing a patient with information regarding the retail price of a prescription drug or the amount of the cost share for which the patient is responsible for a prescription drug.
(2) Discussing with a patient information regarding the retail price of a prescription drug or the amount of the cost share for which the patient is responsible for a prescription drug.
(3) If a more affordable substitute is available, selling the more affordable substitute to the patient.
81 Del. Laws, c. 378, § 1;  83 Del. Laws, c. 256, § 7;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33A. Pharmacy Benefits Managers [For application of this chapter, see 80 Del. Laws, c. 245, §? 2] › Subchapter IV. Prior Authorization of Emergency Prescriptions and Prescriptions for Chronic or Long-Term Conditions › § 3335A. Definitions.

§ 3335A. Definitions.
As used in this subchapter:
(1) “Emergency” means a situation that will result in loss of life, limb or organ function.
(2) “Pharmacy benefit manager” has the meaning given in § 3302A of this title.
(3) “Prior authorization” means a requirement by a carrier or health-insurance plan that providers submit a request or other prior notification to the carrier for evaluation of appropriateness of the request or if the prescription is medically necessary before treatment is rendered. Prior authorization lets the insured and provider know in advance which pharmaceuticals are considered by the insurer to be medically necessary.
81 Del. Laws, c. 379, § 1;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33A. Pharmacy Benefits Managers [For application of this chapter, see 80 Del. Laws, c. 245, §? 2] › Subchapter IV. Prior Authorization of Emergency Prescriptions and Prescriptions for Chronic or Long-Term Conditions › § 3336A. Prior authorization of emergency prescriptions.

§ 3336A. Prior authorization of emergency prescriptions.
A pharmacy benefit manager may not require prior authorization for coverage of a 72-hour supply of medication that is for a noncontrolled substance in an emergency situation.
81 Del. Laws, c. 379, § 1;
2023 Delaware Code › Title 18 - Insurance Code › Chapter 33A. Pharmacy Benefits Managers [For application of this chapter, see 80 Del. Laws, c. 245, §? 2] › Subchapter IV. Prior Authorization of Emergency Prescriptions and Prescriptions for Chronic or Long-Term Conditions › § 3337A. Prior authorization of prescriptions for chronic or long-term conditions.

§ 3337A. Prior authorization of prescriptions for chronic or long-term conditions.
(a) A prior authorization form for a prescription medication shall include a question regarding whether the prescription medication is for a chronic or long-term condition for which the prescription medication may be necessary for the life of the patient.
(b) If a prescriber indicates on a prior authorization form that the prescription medication is for a chronic or long-term condition for which the prescription medication may be necessary for the life of the patient, the pharmacy benefit manager may not request a reauthorization for the same prescription medication more frequently than every 12 months.
(c) In the same communication in which a pharmacy benefit manager or the pharmacy benefit manager's agent requests a prior authorization for a prescription medication that has therapeutically equivalent medications that do not require a prior authorization from a prescriber, the pharmacy benefit manager or the pharmacy benefit manager's agent shall provide the prescriber with a list of alternative prescription medications of the same class and family as the requested medication.
(d) Prescribers that utilize e-prescribing shall receive alternate medications from the pharmacy benefit manager for prescription medications that do not require a prior authorization before the completion of the e-prescribing transaction.
(e) A pharmacy benefit manager or the pharmacy benefit manager's agent shall provide alternative medications for therapeutically equivalent medications to the pharmacy that require prior authorization on the National Council for Prescription Drug Programs response transaction to a denied claim for prior authorization.
81 Del. Laws, c. 379, § 1;