In this section, the following words have the meanings indicated:

(1) “Adverse determination” means a benefit denial, reduction or termination, or determination that an admission or continued stay, or course of treatment, or other covered health service does not satisfy the insurance policy’s clinical requirements for appropriateness, necessity, health-care setting and/or level of care.

(2) “Clean pre-authorization” means when a submission is made to satisfy any pre-authorization in which the relevant data is provided as called for by the utilization review entity. Any request submitted by a provider or covered person that includes an unspecified, unclassified or miscellaneous code or data element to constitute a clean request shall also include appropriate supporting documentation or narrative which explains the unspecified, unclassified or miscellaneous code and describes the diagnosis and treatment rendered.

(3) “Clinical criteria” means the written policies, written screening procedures, drug formularies or lists of covered drugs, determination rules, determination abstracts, clinical protocols, practice guidelines, medical protocols and any other criteria or rationale used by the utilization review entity to determine the necessity and appropriateness of health-care services.

(4) “Covered person” means an individual and/or family who has entered into a contractual arrangement, or on whose behalf a contractual arrangement has been entered into, with a carrier, pursuant to which the carrier provides health insurance for such person or persons.

(5) “Electronic pre-authorization” [ePA] means a submission of information via a website, the Delaware Health Information Network, or other method via the Internet as delineated by regulation and as accepted by the utilization review entity. Electronic pre-authorization does not include any form of request that is transmitted to the utilization review entity through facsimile.

(6) “Emergency health-care services” means those services identified in §§ 3349 and 3565 of this title.

(7) “Health-care service” means any services or supplies included in the furnishing to any individual of medical care, or hospitalization or incidental to the furnishing of such care or hospitalization, as well as the furnishing to any individual of any and all other services for the purpose of preventing, alleviating, curing or healing human illness, injury, disability or disease.

(8) “Medically necessary” or “medical necessity” means providing of health-care services or products that a prudent physician would provide to a patient for the purpose of diagnosing or treating an illness, injury, disease or its symptoms in a manner that is all of the following:

a. In accordance with generally accepted standards of medical practice;

b. Consistent with the symptoms or treatment of the condition;

c. Not solely for anyone’s convenience; and

d. Not including investigational or experimental health-care services.

(9) “NCPDP SCRIPT standard” means the most recent standard adopted of the National Council for Prescription Drug Programs SCRIPT adopted by the United States Department of Health and Human Services. To fall within this definition, any version released subsequent to passage of this section must be compatible to the current version adopted by the United States Department of Health and Human Services.

(10) “Pre-authorization” means a requirement by a carrier or health-insurance plan that providers submit a treatment plan, service request, or other prior notification to the carrier for evaluation of appropriateness of the plan or if the service is medically necessary before treatment is rendered. Pre-authorization lets the insured and provider know in advance which procedures and pharmaceuticals are considered by the insurer to be medically necessary.

(11) “Step therapy exception determination” means a determination as to whether a step therapy protocol should apply in a particular situation, or whether the step therapy protocol should be overridden in favor of immediate coverage of the health-care provider’s selected prescription drug. This determination is based on a review of the request for an override, along with supporting rationale and documentation.

(12) “Step therapy protocol” means a protocol or program that establishes the specific sequence in which prescription drugs for a specified medical condition and medically appropriate for a particular patient are covered by an insurer or health plan.

(13) “Utilization review entity” means an individual or entity which performs pre-authorization or step therapy protocol review for 1 or more of the following entities:

a. An employer with employees who are covered under a health-benefit plan or health-insurance policy or contract issued for delivery in this State or delivered in this State which does not fall under the Employee Retirement Income Security Act (ERISA) [29 U.S.C. § 1001 et seq.];

b. An insurer, health-benefit plan, or health-service corporation that writes health-insurance policies, performs pre-authorization, performs step therapy protocol review or an entity to which these capabilities have been delegated;

c. A preferred-provider organization, managed-care organization, or health-maintenance organization;

d. Any other individual or entity that provides, offers to provide, or administers hospital, outpatient, medical, or other health benefits to a person treated by a health-care provider in Delaware under a policy, plan, or contract;

e. This definition does not include accident-only, credit, dental, vision, long-term care or disability income insurance, coverage issued as a supplement to liability insurance, worker’s compensation, similar insurance or automobile medical payment insurance, or any coverage under state or federal governmental plans.

80 Del. Laws, c. 310, § 1;  82 Del. Laws, c. 44, § 1; 

(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; 

(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; 

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; 

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; 

(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; 

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; 

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; 

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; 

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; 

(a) When coverage of a prescription drug for the treatment of any medical condition is restricted for use by an insurer, health plan, or utilization review entity through the use of a step therapy protocol, the patient and prescribing practitioner shall have access to a clear, readily accessible and convenient process to request a step therapy exception determination. An insurer, health service corporation, health plan, or utilization review entity may use its existing medical exceptions process to satisfy this requirement. The process shall be made easily accessible via the insurer’s, health plan’s, or utilization review entity’s website. A step therapy exception determination shall be expeditiously granted in any one of the following circumstances:

(1) The required prescription drug is contraindicated or will likely cause an adverse reaction by or physical or mental harm to the patient.

(2) The required prescription drug is expected to be ineffective based on the known clinical characteristics of the patient and the known characteristics of the prescription drug regimen.

(3) The patient has tried the required prescription drug while under the patient’s current or previous health insurance or health benefit plan, or another prescription drug in the same pharmacologic class or with the same mechanism of action, and such prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event.

(4) The required prescription drug is not in the best interest of the patient, based on medical necessity.

(5) The patient is stable, for the medical condition under consideration, on a prescription drug prescribed by the patient’s health-care provider or while the patient was insured by the patient’s current or a previous insurance or health benefit plan.

(b) (1) The insurer, health services corporation, health plan, or utilization review entity shall grant or deny a step therapy exception request, which shall be from a health-care provider, and which shall state the circumstance which qualifies the patient for a step therapy exception pursuant to subsection (a) of this section, within 2 business days of receipt of such request. A step therapy exception determination not granted or denied in writing at the end of 2 days shall be deemed granted.

(2) During a step therapy exception determination under (a)(5) of this section, a determination will be deemed granted until the insurer, health services corporation, health plan, or utilization review entity issues a step therapy exception determination.

(c) In cases where emergency circumstances exist, as outlined in § 3349 of this title, an insurer, health plan, or utilization review entity shall grant or deny a step therapy exception request within 24 hours of receipt of a request, which shall be from a health care provider, and which shall state the circumstance which qualifies the patient for a step therapy exception pursuant to subsection (a) of this section. A request shall be deemed granted if the required response is not received by the requesting or appealing party within the times set forth in this subsection.

(d) Upon the granting of a step therapy exception determination, the insurer, health plan, or utilization review entity shall authorize coverage for the prescription drug prescribed by the patient’s treating health-care provider.

(e) This section shall not be construed to prevent any of the following:

(1) An insurer, health plan, or utilization review entity from requiring a patient to try an AB-rated generic equivalent prior to providing coverage for the equivalent branded prescription drug.

(2) A health-care provider from prescribing a prescription drug that is determined to be medically necessary.

(f) Clinical criteria used to establish a step therapy protocol shall be based on clinical criteria that:

(1) Recommend that the prescription drugs be taken in the specific sequence required by the step therapy protocol.

(2) Developed and endorsed by a multidisciplinary panel of experts that manages conflicts of interest among the members of the writing and review groups by:

a. Requiring members to disclose any potential conflict of interests with entities, including insurers, health plans, and pharmaceutical manufacturers and recuse themselves of voting if they have a conflict of interest.

b. Using a methodologist to work with writing groups to provide objectivity in data analysis and ranking of evidence through the preparation of evidence tables and facilitating consensus.

(3) Offer opportunities for public review and comments.

(4) Based on peer reviewed studies, research, and medical practice.

(5) Created by an explicit and transparent process that:

a. Minimizes biases and conflicts of interest.

b. Explains the relationship between treatment options and outcomes.

c. Rates the quality of the evidence supporting recommendations.

d. Considers relevant patient subgroups and preferences.

e. Continually updated through a review of new evidence, research and newly developed treatments.

(6) When establishing a step therapy protocol, a utilization review entity shall also take into account the needs of atypical patient populations and diagnoses when establishing clinical criteria.

(7) This section shall not be construed to require insurers, health plans or the state to set up a new entity to develop clinical review criteria used for step therapy protocols.

(g) Any step therapy exception determination as defined by this subsection shall be eligible for appeal by an insured or their authorized representative, as outlined in Chapter 3 and Chapter 64 of this title.

82 Del. Laws, c. 44, § 1;