Health Insurance Contracts

Del. Code tit. 18, ch. 33

in effect

Del. Code tit. 18, § 3301 Scope of chapter.

This chapter shall not apply to or affect: (1) Any policy of liability or workers’ compensation insurance with or without supplementary expense coverage therein; (2) Any group or blanket policy; (3) Life insurance, endowment or annuity contracts, or contracts supplemental thereto which contain only such provisions relating to health insurance as: a. Provide additional benefits in case of death or dismemberment or loss of sight by accident or accidental means; or as b. Operate to safeguard such contracts against lapse, or to give a special surrender value or special benefit or an annuity in the event that the insured or annuitant becomes totally and permanently disabled, as defined by the contract or supplemental contract; (4) Reinsurance.

Del. Code tit. 18, § 3302 Short title.

This subchapter may be cited as the “Uniform Health Policy Provisions Law.”

Del. Code tit. 18, § 3303 Scope, format of policy [For application of this section, see 79 Del. Laws, c. 99, § 19].

No policy of health insurance shall be delivered or issued for delivery to any person in this State unless it otherwise complies with this title and complies with the following: (1) The entire money and other considerations therefor shall be expressed therein; (2) The time when the insurance takes effect and terminates shall be expressed therein; (3) It shall purport to insure only 1 person, except that a policy may insure, originally or by subsequent amendment, upon the application of an adult member of a family, who shall be deemed the policyholder, any 2 or more eligible members of that family, including husband, wife, dependent children or any children under a specified age which shall not exceed 26 years and any other person dependent upon the policyholder; (4) The style, arrangement and overall appearance of the policy shall give no undue prominence to any portion of the text, and every printed portion of the text of the policy and of any endorsements or attached papers shall be plainly printed in light-faced type of a style in general use, the size of which shall be uniform and not less than 10 points with a lower case unspaced alphabet length not less than 120 points (the “text” shall include all printed matter except the name and address of the insurer, name or title of the policy, the brief description, if any, and captions and subcaptions); (5) The exceptions and reductions of indemnity shall be set forth in the policy and, other than those contained in §§ 3305-3326, inclusive, of this title, shall be printed, at the insurer’s option, either included with the benefit provision to which they apply, or under an appropriate caption such as “exceptions,” or “exceptions and reductions,” except that if an exception or reduction specifically applies only to a particular benefit of the policy, a statement of such exception or reduction shall be included with the benefit provision to which it applies; (6) Each such form, including riders and endorsements, shall be identified by a form number in the lower left-hand corner of the first page thereof; and (7) The policy shall contain no provision purporting to make any portion of the charter, rules, constitution or bylaws of the insurer a part of the policy unless such portion is set forth in full in the policy, except in the case of the incorporation of, or reference to, a statement of rates or classification of risks, or short-rate table filed with the Commissioner. (8) The policy shall contain no provision or nondisclosure clause prohibiting physicians or other health-care providers from giving patients information regarding diagnoses, prognoses and treatment options.

Del. Code tit. 18, § 3304 Required provisions; captions; omissions; substitutions.

(a) Except as provided in subsection (b) of this section below, each such policy delivered or issued for delivery to any person in this State shall contain the provisions specified in §§ 3305-3316, inclusive, of this title, in the words in which the same appear; except, that the insurer may, at its option, substitute for 1 or more of such provisions corresponding provisions of different wording approved by the Commissioner which are in each instance not less favorable in any respect to the insured or the beneficiary. Each such provision shall be preceded individually by the applicable caption shown, or, at the option of the insurer, by such appropriate individual or group captions or subcaptions as the Commissioner may approve. (b) If any such provision is in whole or in part inapplicable to or inconsistent with the coverage provided by a particular form of policy, the insurer, with the approval of the Commissioner, shall omit from such policy any inapplicable provision or part of a provision and shall modify any inconsistent provision or part of a provision in such manner as to make the provision as contained in the policy consistent with the coverage provided by the policy.

Del. Code tit. 18, § 3305 Entire contract; changes.

There shall be a provision as follows: “Entire Contract; Changes: This policy, including the endorsements and the attached papers, if any, constitutes the entire contract of insurance. No change in this policy shall be valid until approved by an executive officer of the company and unless such approval be endorsed hereon or attached hereto. No agent has authority to change this policy or to waive any of its provisions.”

Del. Code tit. 18, § 3306 Time limit on certain defenses.

(a) There shall be a provision as follows: “Time Limit on Certain Defenses: (1) After 2 years from the date of issue of this policy, no misstatements, except fraudulent misstatements, made by the applicant in the application for such policy shall be used to void the policy or deny a claim for loss incurred as disability (as defined in the policy) commencing after the expiration of such 2-year period. (2) No claim for loss incurred as disability (as defined in the policy) commencing 2 years from the date of issue of this policy shall be reduced or denied on the ground that a disease or physical condition not excluded from coverage by name or specific description effective on the date of loss had existed prior to the effective date of coverage of this policy.” (b) The policy provision required by paragraph (a)(1) of this section above shall not be so construed as to affect any legal avoidance of a policy or denial of a claim during such initial 2-year period, nor to limit the application of §§ 3318-3320 of this title in the event of misstatement with respect to age or occupation or other insurance. (c) A policy which the insured has the right to continue in force subject to its terms by the timely payment of premium (1) until at least age 50, or (2) in the case of a policy issued after age 44, for at least 5 years from its date of issue, may contain in lieu of the foregoing the following provision (from which the clause in parentheses may be omitted at the insurer’s option) under the caption “Incontestable”: “After this policy has been in force for a period of 2 years during the lifetime of the insured (excluding any period during which the insured is disabled), it shall become incontestable as to any statements, other than fraudulent statements, contained in the application.”

Del. Code tit. 18, § 3307 Grace period.

There shall be a provision as follows: “A grace period of . . . (insert a number not less than “7” for weekly premium policies, “10” for monthly premium policies and “31” for all other policies) days will be granted for the payment of each premium falling due after the first premium, during which grace period the policy shall continue in force.” A policy in which the insurer reserves the right to refuse any renewal shall have, at the beginning of the above provision: “Unless not less than five days prior to the premium due date the company has delivered to the insured or has mailed to his/her last address as shown by the records of the company written notice of its intention not to renew this policy beyond the period for which the premium has been accepted.”

Del. Code tit. 18, § 3308 Reinstatement.

(a) There shall be a provision as follows: “Reinstatement: If any renewal premium be not paid within the time granted the insured for payment, a subsequent acceptance of premium by the insurer or by any agent duly authorized by the company to accept such premium, without requiring in connection therewith an application for reinstatement, shall reinstate the policy, provided, however, that if the company or such agent requires an application for reinstatement and issues a conditional receipt for the premium tendered, the policy will be reinstated upon approval of such application by the company or, lacking such approval, upon the forty-fifth day following the date of such conditional receipt unless the company has previously notified the insured in writing of its disapproval of such application. The reinstated policy shall cover only loss resulting from such accidental injury as may be sustained after the date of reinstatement and loss due to such sickness as may begin more than ten days after such date. In all other respects the insured and company shall have the same rights thereunder as they had under the policy immediately before the due date of the defaulted premium, subject to any provisions endorsed herein or attached hereto in connection with the reinstatement. Any premium accepted in connection with a reinstatement shall be applied to a period for which premium has not been previously paid, but not to any period more than sixty days prior to the date of reinstatement.” (b) The last sentence of the above provision may be omitted from any policy which the insured has the right to continue in force subject to its terms by the timely payment of premiums: (1) Until at least age 50; or (2) In the case of a policy issued after age 44, for at least 5 years from its date of issue.

Del. Code tit. 18, § 3309 Notice of claim.

(a) There shall be a provision as follows: “Notice of Claim: Written notice of claim must be given to the company within twenty days after the occurrence or commencement of any loss covered by the policy, or as soon thereafter as is reasonably possible. Notice given by or on behalf of the insured or the beneficiary to the company at . . . . . . . . . . . . . . (insert the location of such office as the company may designate for the purpose), or to any authorized agent of the company, with information sufficient to identify the insured, shall be deemed notice to the company.” (b) In a policy providing a loss-of-time benefit which may be payable for at least 2 years, an insurer may at its option insert the following between the first and second sentences of the above provision: “Subject to the qualifications set forth below, if the insured suffers loss of time on account of disability for which indemnity may be payable for at least two years, he/she shall, at least once in every six months after having given notice of the claim, give to the company notice of continuance of the disability, except in the event of legal incapacity. The period of six months following any filing of proof by the insured or any payment by the company on account of such claim or any denial of liability in whole or in part by the company shall be excluded in applying this provision. Delay in the giving of such notice shall not impair the insured’s right to any indemnity which would otherwise have accrued during the period of six months preceding the date on which such notice is actually given.”

Del. Code tit. 18, § 3310 Claim.

There shall be a provision as follows: “Claim Forms: The company, upon receipt of a notice of claim, will furnish to the claimant such forms as are usually furnished by it for filing proofs of loss. If such forms are not furnished within fifteen days after the giving of such notice the claimant shall be deemed to have complied with the requirements of this policy as to proof of loss upon submitting, within the time fixed in the policy for filing proofs of loss, written proof covering the occurrence, the character and the extent of the loss for which claim is made. The nonhospital claim form to be used under this provision is the Health Care Financing Administration Form-1500 or its successor. This form requirement shall not apply to medical payments made by the federal government, prescription drug claims, dental claims or claims using an electronic paperless submission process.”

Del. Code tit. 18, § 3311 Proofs of loss.

There shall be a provision as follows: “Proofs of Loss: Written proof of loss must be furnished to the company at its said office in case of claim for loss for which this policy provides any periodic payment contingent upon continuing loss within ninety days after the termination of the period for which the company is liable and in case of claim for any other loss within ninety days after the date of such loss. Failure to furnish such proof within the time required shall not invalidate nor reduce any claim if it was not reasonably possible to give proof within such time, provided such proof is furnished as soon as reasonably possible and in no event, except in the absence of legal capacity, later than one year from the time proof is otherwise required.”

Del. Code tit. 18, § 3312 Time of payment of claims.

There shall be a provision as follows: “Time of Payment of Claims: Indemnities payable under this policy for any loss other than loss for which this policy provides any periodic payment will be paid immediately upon receipt of due written proof of such loss. Subject to due written proof of loss, all accrued indemnities for loss for which this policy provides periodic payment will be paid . . . . . . . . . . . . (insert period for payment which must not be less frequently than monthly) and any balance remaining unpaid upon the termination of liability will be paid immediately upon receipt of due written proof.”

Del. Code tit. 18, § 3313 Payment of claims.

(a) There shall be a provision as follows: “Payment of Claims: Indemnity for loss of life will be payable in accordance with the beneficiary designation and the provisions respecting such payment which may be prescribed herein and effective at the time of payment. If no such designation or provision is then effective, such indemnity shall be payable to the estate of the insured. Any other accrued indemnities unpaid at the insured’s death may, at the option of the company, be paid either to such beneficiary or to such estate. All other indemnities will be payable to the insured.” (b) The following provisions, or either of them, may be included with the foregoing provision at the option of the insurer: (1) “If any indemnity of this policy shall be payable to the estate of the insured, or to an insured or beneficiary who is a minor or otherwise not competent to give a valid release, the company may pay such indemnity, up to an amount not exceeding $. . . . . . . . . . . . (insert an amount which shall not exceed $1,000), to any relative by blood or connection by marriage of the insured or beneficiary who is deemed by the company to be equitably entitled thereto. Any payment made by the company in good faith pursuant to this provision shall fully discharge the company to the extent of such payment.” (2) “Subject to any written direction of the insured in the application or otherwise all or a portion of any indemnities provided by this policy on account of hospital, nursing, medical or surgical services may, at the company’s option and unless the insured requests otherwise in writing not later than the time of filing proofs of such loss, be paid directly to the hospital or person rendering such services, but it is not required that the service be rendered by a particular hospital or person.” (c) There shall be a provision as follows in contracts issued by an insurer, health service corporation or health maintenance organization: “Payment of claims when coverage terminated during a period of hospitalization: If you are in the hospital when this policy nonrenews or terminates for any reason except nonpayment of premium, this policy shall continue coverage for that hospitalization at the same benefit level for a 10-day period from the date of termination.” (d) There shall be a provision as follows in contracts issued by an insurer, health service corporation or health maintenance organization: “If this policy immediately succeeds prior coverage, and if you are in the hospital when this coverage becomes effective, benefits for that hospitalization will start at the end of 10 consecutive days of hospitalization under this policy at the level provided by this policy notwithstanding any preexisting conditions or other similar exclusions for the duration of the single continuing period of hospitalization.” The requirements of this subsection shall not apply to specified accident, specified disease, hospital indemnity, Medicare supplement, long-term care or other limited benefit health insurance policies.

Del. Code tit. 18, § 3314 Physical examination; autopsy.

There shall be a provision as follows: “Physical Examinations and Autopsy: The company at its own expense shall have the right and opportunity to examine the person of the insured when and as often as it may reasonably require during the pendency of a claim hereunder and to make an autopsy in case of death where it is not forbidden by law.”

Del. Code tit. 18, § 3315 Legal actions.

There shall be a provision as follows: “Legal Actions: No action at law or in equity shall be brought to recover on this policy prior to the expiration of sixty days after written proof of loss has been furnished in accordance with the requirements of this policy. No such action shall be brought after the expiration of three years after the time written proof of loss is required to be furnished.”

Del. Code tit. 18, § 3316 Change of beneficiary.

(a) There shall be a provision as follows: “Change of Beneficiary: Unless the insured make an irrevocable designation of beneficiary, the right to change the beneficiary is reserved to the insured and the consent of the beneficiary or beneficiaries shall not be requisite to surrender or assignment of this policy or to any change of beneficiary or beneficiaries, or to any other changes in this policy.” (b) The first clause of this provision, relating to the irrevocable designation of beneficiary, may be omitted at the insurer’s option.

Del. Code tit. 18, § 3317 Optional policy provisions.

Except as provided in § 3304 of this title, no such policy delivered or issued for delivery to any person in this State shall contain provisions respecting the matters set forth in §§ 3318-3325, inclusive, of this title unless such provisions are in the words in which the same appear in the applicable section, except that the insurer may, at its option, use in lieu of any such provision a corresponding provision of different wording approved by the Commissioner which is not less favorable in any respect to the insured or the beneficiary. Any such provision contained in the policy shall be preceded individually by the appropriate caption or at the option of the insurer, by such appropriate individual or group captions or subcaptions as the Commissioner may approve.

Del. Code tit. 18, § 3318 Change of occupation.

There may be a provision as follows: “Change of Occupation: If the insured be injured or contract sickness after having changed his/her occupation to one classified by the company as more hazardous than that stated in this policy or while doing for compensation anything pertaining to an occupation so classified, the company will pay only such portion of the indemnities provided in this policy as the premium paid would have purchased at the rates and within the limits fixed by the company for such more hazardous occupation. If the insured changes his/her occupation to one classified by the company as less hazardous than that stated in this policy, the company, upon receipt of proof of such change of occupation, will reduce the premium rate accordingly and will return the excess pro rata unearned premium from the date of change of occupation or from the policy anniversary date immediately preceding receipt of such proof, whichever is the more recent. In applying this provision, the classification of occupational risk and the premium rates shall be such as have been last filed by the company prior to the occurrence of the loss for which the company is liable or prior to date of proof of change in occupation with the state official having supervision of insurance in the state where the insured resided at the time this policy was issued, but if such filing was not required, then the classification of occupational risk and the premium rates shall be those last made effective by the company in such state prior to the occurrence of the loss or prior to the date of proof of change in occupation.”

Del. Code tit. 18, § 3319 Misstatement of age.

There may be a provision as follows: “Misstatement of Age: If the age of the insured has been misstated, all amounts payable under this policy shall be such as the premium paid would have purchased at the correct age.”

Del. Code tit. 18, § 3320 Overinsurance; all coverages.

(a) There may be a provision as follows: “Overinsurance: If, with respect to a person covered under this policy, benefits for allowable expense incurred during a claim determination period under this policy together with benefits for allowable expense during such period under all other valid coverage (without giving effect to this provision or to any ‘overinsurance provision’ applying to such other valid coverage), exceed the total of such person’s allowable expense during such period, this company shall be liable only for such proportionate amount of the benefits for allowable expense under this policy during such period as: (1) The total allowable expense during such period bears to (2) The total amount of benefits payable during such period for such expense under this policy and all other valid coverage (without giving effect to this provision or to any ‘overinsurance provision’ applying to such other valid coverage) less in both (1) and (2) any amount of benefits for allowable expense payable under other valid coverage which does not contain an ‘overinsurance provision.’ In no event shall this provision operate to increase the amount of benefits for allowable expense payable under this policy with respect to a person covered under this policy above the amount which would have been paid in the absence of this provision. This company may pay benefits to any insurer providing other valid coverage in the event of overpayment by such insurer. Any such payment shall discharge the liability of this company as fully as if the payment had been made directly to the insured, his/her assignee or his/her beneficiary. In the event that this company pays benefits to the insured, his/her assignee or his/her beneficiary, in excess of the amount which would have been payable if the existence of other valid coverage had been disclosed, this company shall have a right of action against the insured, his/her assignee or his/her beneficiary, to recover the amount which would not have been paid had there been a disclosure of the existence of the other valid coverage. The amount of other valid coverage which is on a provision of service basis shall be computed as the amount the services rendered would have cost in the absence of such coverage. For the purposes of this provision: (1) ‘Allowable expense’ means 110% of any necessary, reasonable and customary item of expense which is covered, in whole or in part, as a hospital, surgical, medical or major medical expense under this policy or under any other valid coverage. (2) ‘Claim determination period’ with respect to any covered person means the initial period of . . . (insert period of not less than 30 days) and each successive period of a like number of days, during which allowable expense covered under this policy is incurred on account of such person. The first such period begins on the date when the first such expense is incurred, and successive periods shall begin when such expense is incurred after expiration of a prior period. or, in lieu thereof: ‘Claim determination period’ with respect to any covered person means each . . . (insert calendar or policy period of not less than a month) during which allowable expense covered under this policy is incurred on account of such person. (3) ‘Overinsurance provision’ means this provision and any other provision which may reduce an insurer’s liability because of the existence of benefits under other valid coverage.” (b) The foregoing policy provisions may be inserted in all policies providing hospital, surgical, medical or major medical benefits. The insurer may make this provision applicable to either or both (1) other valid coverage with other insurers, and (2) other valid coverage with the same insurer. The insurer shall include in this provision a definition of “other valid coverage” approved as to form by the Commissioner. Such term may include hospital, surgical, medical or major medical benefits provided by group, blanket or franchise coverage, individual and family-type coverage, Blue Cross-Blue Shield coverage and other prepayment plans, group practice and individual practice plans, uninsured benefits provided by labor-management trusteed plans, or union welfare plans, or by employer or employee benefit organizations, benefits provided under governmental programs, workers’ compensation insurance or any coverage required or provided by any other statute, and medical payments under automobile liability and personal liability policies. Other valid coverage shall not include payments made under third-party liability coverage as a result of a determination of negligence, but an insurer may at its option include a subrogation clause in its policy. The insurer may require, as part of the proof of claim, the information necessary to administer this provision. (c) If by application of any of the foregoing provisions the insurer effects a material reduction of benefits otherwise payable under the policy, the insurer shall refund to the insured any premium unearned on the policy by reason of such reduction of coverage subject to the insurer’s right to provide in the policy that no such reduction of benefits or refund will be made unless the unearned premium to be so refunded amounts to $5.00 or such larger sum as the insurer may specify.

Del. Code tit. 18, § 3321 Relation of earnings to insurance.

(a) There may be a provision as follows: “After the loss-of-time benefit of this policy has been payable for 90 days, such benefit will be adjusted, as provided below, if the total amount of unadjusted loss-of-time benefits provided in all valid loss-of-time coverage upon the insured should exceed . . . % of the insured’s earned income, provided, however, that if the information contained in the application discloses that the total amount of loss-of-time benefits under this policy and under all other valid loss-of-time coverage expected to be effective upon the insured in accordance with the application for this policy exceeded . . . % of the insured’s earned income at the time of such application, such higher percentage will be used in place of . . . %. Such adjusted loss-of-time benefit under this policy for any month shall be only such proportion of the loss-of-time benefit otherwise payable under this policy as: (1) The product of the insured’s earned income and . . . % (or, if higher the alternative percentage described at the end of the first sentence of this provision) bears to (2) The total amount of loss-of-time benefits payable for such month under this policy and all other valid loss-of-time coverage on the insured (without giving effect to the ‘overinsurance provision’ in this or any other coverage) less in both (1) and (2) any amount of loss-of-time benefits payable under other valid loss-of-time coverage which does not contain an ‘overinsurance provision.’ In making such computation, all benefits and earnings shall be converted to a consistent (insert ‘weekly’ if the loss-of-time benefit of this policy is payable weekly, ‘monthly’ if such benefit is payable monthly, etc.) basis. If the numerator of the foregoing ratio is zero or is negative, no benefit shall be payable under this policy. In no event shall this provision (i) operate to reduce the total combined amount of loss-of-time benefits for such month payable under this policy and all other valid loss-of-time coverage below the lesser of $300 and the total combined amount of loss-of-time benefits determined without giving effect to any ‘overinsurance provision,’ nor (ii) operate to increase the amount of benefits payable under this policy above the amount which would have been paid in the absence of this provision, nor (iii) take into account or operate to reduce any benefit other than the loss-of-time benefit. For purposes of this provision: (A) ‘Earned income’, except where otherwise specified, means the greater of the monthly earnings of the insured at the time disability commences and his/her average monthly earnings for a period of two years immediately preceding the commencement of such disability and shall not include any investment income or any other income not derived from the insured’s vocational activities. (B) ‘Overinsurance provision’ shall include this provision and any other provision with respect to any loss-of-time coverage which may have the effect of reducing an insurer’s liability if the total amount of loss-of-time benefits under all coverage exceeds a stated relationship to the insured’s earnings.” (b) The foregoing provision may be included only in a policy which provides a loss-of-time benefit which may be payable for at least 52 weeks, which is issued on the basis of selective underwriting of each individual application, and for which the application includes a question designed to elicit information necessary either to determine the ratio of the total loss-of-time benefits of the insured to the insured’s earned income or to determine that such ratio does not exceed the percentage of earnings, not less than 60% selected by the insurer and inserted in lieu of the blank factor above. The insurer may require, as part of the proof of claim, the information necessary to administer this provision. If the application indicates that other loss-of-time coverage is to be discontinued, the amount of such other coverage shall be excluded in computing the alternative percentage in the first sentence of the overinsurance provision. The policy shall include a definition of “valid loss-of-time coverage,” approved as to form by the Commissioner, which definition may include coverage provided by governmental agencies and by organizations subject to regulation by insurance law and by insurance authorities of this or any other state of the United States or of any other country or subdivision thereof, coverage provided for such insured pursuant to any disability benefits statute or any workers’ compensation or employer’s liability statute, benefits provided by labor-management trusteed plans or union welfare plans or by employer or employee benefit organizations, or by salary continuance or pension programs, and any other coverage the inclusion of which may be approved by the Commissioner. (c) If by application of any of the foregoing provisions the insurer effects a material reduction of benefits otherwise payable under the policy, the insurer shall refund to the insured any premium unearned on the policy by reason of such reduction of coverage, subject to the insurer’s right to provide in the policy that no such reduction of benefits or refund will be made unless the unearned premium to be so refunded amounts to $5.00 or such larger sum as the insurer may so specify.

Del. Code tit. 18, § 3322 Unpaid premiums.

There may be a provision as follows: “Unpaid Premium: Upon the payment of a claim under this policy, any premium then due and unpaid or covered by any note or written order may be deducted therefrom.”

Del. Code tit. 18, § 3323 Conformity with state statutes.

There may be a provision as follows: “Conformity with State Statutes: Any provision of this policy which, on its effective date is in conflict with the statutes of the state in which the insured resides on such date is hereby amended to conform to the minimum requirements of such statutes.”

Del. Code tit. 18, § 3324 Illegal occupation.

There may be a provision as follows: “Illegal Occupation: The company shall not be liable for any loss to which a contributing cause was the insured’s commission of or attempt to commit a felony or to which a contributing cause was the insured’s being engaged in an illegal occupation.”

Del. Code tit. 18, § 3325 Intoxicants and narcotics.

There may be a provision as follows: “Intoxicants and Narcotics: The company shall not be liable for any loss sustained or contracted in consequence of the insured’s being intoxicated or under the influence of any narcotic unless administered on the advice of a physician.”

Del. Code tit. 18, § 3326 Renewability.

Health insurance policies, other than accident insurance only policies, in which the insurer reserves the right to refuse renewal on an individual basis, shall provide in substance in a provision thereof or in an endorsement thereon or rider attached thereto that subject to the right to terminate the policy upon nonpayment of premium when due, such right to refuse renewal may not be exercised so as to take effect before the renewal date occurring on, or after and nearest, each policy anniversary (or in the case of lapse and reinstatement, at the renewal date occurring on, or after and nearest, each anniversary of the last reinstatement), and that any refusal of renewal shall be without prejudice to any claim originating while the policy is in force. (The parenthetic reference to lapse and reinstatement may be omitted at the insurer’s option.)

Del. Code tit. 18, § 3327 Order of certain provisions.

The provisions which are the subject of §§ 3305-3326, inclusive, of this title, or any corresponding provisions which are used in lieu thereof in accordance with such sections shall be printed in the consecutive order of the provisions in such sections or, at the option of the insurer, any such provision may appear as a unit in any part of the policy, with other provisions to which it may be logically related, provided that the resulting policy shall not be in whole or in part unintelligible, uncertain, ambiguous, abstruse, or likely to mislead a person to whom the policy is offered, delivered or issued.

Del. Code tit. 18, § 3328 Third-party ownership.

The word “insured,” as used in this subchapter, shall not be construed as preventing a person other than the insured with a proper insurable interest from making application for and owning a policy covering the insured or from being entitled under such a policy to any indemnities, benefits, and rights provided therein.

Del. Code tit. 18, § 3329 Requirements of other jurisdictions.

(a) Any policy of a foreign or alien insurer, when delivered or issued for delivery to any person in this State, may contain any provision which is not less favorable to the insured or the beneficiary than the provisions of this chapter and which is prescribed or required by the law of the state or country under which the insurer is organized. (b) Any policy of a domestic insurer may, when issued for delivery in any other state or country, contain any provision permitted or required by the laws of such other state or country.

Del. Code tit. 18, § 3330 Policies issued for delivery in another state.

If any policy is issued by a domestic insurer for delivery to a person residing in another state, and if the insurance commissioner or corresponding public official of such other state has informed the Commissioner that any such policy is not subject to approval or disapproval by such official, the Commissioner may by ruling require that the policy meet the standards set forth in §§ 3303-3329, inclusive, of this title.

Del. Code tit. 18, § 3331 Conforming to statute.

(a) No policy provision which is not subject to this chapter shall make a policy, or any portion thereof, less favorable in any respect to the insured or the beneficiary than the provisions thereof which are subject to this chapter. (b) A policy delivered or issued for delivery to any person in this State in violation of this chapter shall be held valid but shall be construed as provided in this chapter. When any provision in a policy subject to this chapter is in conflict with any provision of this chapter, the rights, duties, and obligations of the insurer, the insured and the beneficiary shall be governed by the provisions of this chapter.

Del. Code tit. 18, § 3332 Age limit.

If any such policy contains a provision establishing, as an age limit or otherwise, a date after which the coverage provided by the policy will not be effective, and if such date falls within a period for which premium is accepted by the insurer or if the insurer accepts a premium after such date, the coverage provided by the policy will continue in force until the end of the period for which the premium has been accepted. In the event the age of the insured has been misstated and if, according to the correct age of the insured, the coverage provided by the policy would not have become effective, or would have ceased prior to the acceptance of such premium or premiums, then the liability of the insurer shall be limited to the refund, upon request, of all premiums paid for the period not covered by the policy.

Del. Code tit. 18, § 3333 Filing of rates.

Each insurer issuing health insurance policies for delivery in this State shall, before use thereof, file with the Commissioner its premium rates and classification of risks pertaining to such policies. The insurer shall adhere to its rates and classifications as filed with the Commissioner. The insurer may change such filings from time to time as it deems proper. The filing of rates shall be made pursuant to and under the requirements of Chapter 25 of this title.

Del. Code tit. 18, § 3334 Franchise health insurance law.

Health insurance on a franchise plan is hereby declared to be that form of health insurance issued to: (1) Three or more employees of any corporation, copartnership, or individual employer or any governmental corporation, agency or department thereof; or (2) Ten or more members, employees or employees of members of any trade or professional association or of a labor union or of any other association having had an active existence for at least 2 years where such association or union has a constitution or bylaws and is formed in good faith for purposes other than that of obtaining insurance; where such persons with or without their dependents are issued the same form of an individual policy varying only as to amounts and kinds of coverage applied for by such persons under an arrangement whereby the premiums on such policies may be paid to the insurer periodically by the employer, with or without payroll deductions, or by the association or union for its members, or by some designated person acting on behalf of such employer or association or union. The term “employees” as used herein may be deemed to include the officers, managers and employees and retired employees of the employer and the individual proprietor or partners if the employer is an individual proprietor or partnership.

Del. Code tit. 18, § 3335 Newborn children.

(a) All individual and group health insurance policies providing coverage on an expense-incurred basis, and individual and group service or indemnity-type contracts issued by a nonprofit corporation, which provide coverage for a family member of the insured or subscriber, shall, as to such family members’ coverage, also provide that the health insurance benefits applicable for children shall be payable with respect to a newly born child of the insured or subscriber from the moment of birth. (b) The coverage for newly born children shall consist of coverage for injury or sickness, including the necessary care and treatment of medically diagnosed congenital defects and birth abnormalities as well as routine care furnished any infant from the moment of birth. (c) If payment of a specific premium or subscription fee is required to provide coverage for a child, the policy or contract may require that notification of the birth of a newly born child, and payment of the required premium or fees, must be furnished to the insurer or nonprofit service or indemnity corporation within 31 days after the date of birth in order to have the coverage continued beyond such 31-day period.

Del. Code tit. 18, § 3336 Midwife services reimbursement.

(a) This section shall apply to every individual policy, contract or certificate issued thereunder, of health or sickness or accident insurance delivered or issued for delivery within the State which meets the requirements of subsection (d) of this section. (b) This section shall apply to all such policies, contracts, certificates or programs issued, renewed, modified, altered, amended or reissued on or after September 9, 1988. (c) This section shall apply to all private and public programs for health services and facilities reimbursement, including but not limited to any such reimbursement programs operated by the State. (d) Whenever an insurance policy, contract or certificate or health services reimbursement program provides for reimbursement for any health-care service which is within those areas of practice for which a midwife may be licensed pursuant to § 122 of Title 16 or pursuant to statute in the state where the service is delivered, or for the cost of birthing facilities, the insured or any other person covered by the policy, contract or certificate, or health services or facilities reimbursement program shall be entitled to reimbursement for such service or use of the facilities performed by a duly licensed certified nurse midwife practicing within those areas for which the certified nurse midwife is licensed in the state where the licensed certified nurse midwife is practicing. Whenever such service is performed by a licensed certified nurse midwife and reimbursed by a professional health services plan corporation, the licensed certified nurse midwife shall be granted such rights of participation, plan admission and registration as may be granted by the professional health services plan corporation, to a physician or osteopath performing such a service. When payment is made for health-care services performed by a licensed certified nurse midwife, no payment or reimbursement shall be payable to a physician or osteopath for the services performed by the licensed certified nurse midwife. (e) For the purposes of this section, “midwifery” shall only include those having the following qualifications: (1) Age of 21 years or older; (2) Licensed as a registered professional nurse in the State; (3) Possesses a valid certification by the American College of Nurse Midwives; (4) Submits a sworn statement that he or she has not been convicted of a felony; been professionally penalized or convicted of substance addiction; had a professional nursing license suspended or revoked in this or another state; been professionally penalized or convicted of fraud; is physically and mentally capable of engaging in the practice of midwifery; and (5) Has formed an alliance which is defined as a relationship between a midwife and a physician(s) licensed to practice medicine or osteopathy in Delaware whereby medical consultation and referral, available on a 24-hour basis, is agreed upon in writing, signed by both parties, and filed with the Department of Health and Social Services.

Del. Code tit. 18, § 3337 Lead poisoning screening reimbursement [For application of this section, see 83 Del. Laws, c. 75, § 9].

(a) All individual health insurance policies which are delivered or issued for delivery in this State by any health insurer, health service corporation, health maintenance organization, or any health services and facilities reimbursement program operated by the State and which provide a benefit for outpatient services shall provide a benefit for a baseline lead poisoning screening or testing, as defined in § 2601 of Title 16. (b) Benefits must also be provided for lead poisoning screening, testing, diagnostic evaluations, screening and testing supplies, and home-visits for children who are at high risk for lead poisoning under guidelines and criteria established by the Division of Public Health. (c) The benefits required under subsections (a) and (b) of this section are a covered service, notwithstanding any policy exclusions for services which are part of or related to annual or routine examinations. (d) Nothing in this section prevents the operation of policy provisions such as deductibles, coinsurance allowable charge limitations, coordination of benefits, or provisions restricting coverage to services rendered by licensed, certified, or carrier-approved providers or facilities. (e) This section does not apply to accident-only, specified disease, hospital indemnity, Medicare supplement, long-term care, or other limited health insurance policies.

Del. Code tit. 18, § 3338 Coverage of ovarian cancer monitoring and screening tests [For application of this section, see 84 Del. Laws, c. 254, § 4].

(a) Every individual health, sickness or accident insurance policy, contract or certificate, which is delivered or issued for delivery in this State by any health insurer, health service corporation or health maintenance organization, and which provides benefits for outpatient services, shall provide to covered persons residing in this State a benefit for monitoring tests for ovarian cancer subsequent to treatment and annual screening tests for women at risk for ovarian cancer. Such monitoring or screening tests shall be deemed a covered service. The terms of such coverage, including cost-sharing requirements, shall be no less favorable than the terms of coverage, including cost-sharing requirements, applicable to screening mammography for breast cancer. (b) This section does not apply to any of the following: (1) Accident-only, specified disease, hospital indemnity, Medicare supplement, long-term care, disability income, or other limited benefit health insurance policies. (2) A high deductible health plan if providing coverage under subsection (a) of this section would cause the plan to fail to be treated as a high deductible health plan under § 223(c)(2) of the Internal Revenue Code [26 U.S.C. § 223(c)(2)]. (3) A catastrophic health plan if providing coverage under subsection (a) of this section would cause the plan to fail to be treated as a catastrophic plan under § 1302(e) of the Patient Protection and Affordable Care Act, 42 U.S.C. § 18022(e). (c) If, at any time, the State is required under federal law to defray the cost of any coverage required under this section, the requirements under this section are inoperative and the State does not assume any obligation for the cost of coverage. (d) For purposes of this section: (1) “At risk for ovarian cancer” means any of the following: a. Having a family history of any of the following: 1. One or more first- or second-degree relatives with ovarian cancer. 2. Clusters of women relatives with breast cancer. 3. Nonpolyposis colorectal cancer. 4. Breast cancer in a male relative. b. Testing positive for any of the following genetic mutations: 1. BRCA1 or BRCA2. 2. Lynch syndrome. c. Having a personal history of any of the following: 1. Ovarian cancer. 2. Endometriosis. 3. Unexplained infertility. 4. Uterine fibroids. 5. Polycystic ovarian syndrome. (2) “Cost-sharing requirement” means a deductible, coinsurance, or copayment and any maximum limitation on the application of such a deductible, coinsurance, payment, or similar out-of-pocket expense. (3) “Monitoring tests” and “screening tests” mean tests and examinations for ovarian cancer using any of the following methods that are recommended by a patient’s physician: a. Tumor marker tests supported by national clinical guidelines, national standards of care, or peer-reviewed medical literature. b. Transvaginal ultrasound. c. Pelvic examination. d. Other screening tests supported by national clinical guidelines, national standards of care, or peer reviewed medical literature.

Del. Code tit. 18, § 3338A Equal reimbursement for oral and intravenous anticancer medication.

(a) Every individual policy or contract of health insurance, or certificate issued thereunder, which is delivered, issued for delivery, renewed, modified, altered, or amended in this State on or after January 1, 2013, and which provides medical, major medical, or similar comprehensive-type coverage, and provides coverage for prescription drugs, and which also provides coverage for anticancer medication, must provide coverage for a prescribed, orally administered anticancer medication used to kill or slow the growth of cancerous cells, and must apply the lower cost sharing of either: (1) Anticancer medication under the prescription drug benefit; or (2) Intravenous or injected anticancer medications. For purposes of this section, the term “cost sharing” may include co-pays, coinsurance, and deductibles, as considered appropriate by the Commissioner. (b) An insurer who provides coverage under this section and any participating entity through which the insurer offers health services may not: (1) Vary the terms of the policy for the purpose of or with the effect of avoiding compliance with this section; (2) Provide incentives, monetary or otherwise, to encourage a covered person to accept less than the minimum protections available under this section; (3) Penalize in any way or reduce or limit the compensation of a healthcare practitioner for recommending or providing care to a covered person in accordance with this section; (4) Provide incentives, monetary or otherwise, to a healthcare practitioner relating to the services provided pursuant to this section, intended to induce or have the effect of inducing the practitioner to provide care to a covered person in a manner inconsistent with this section; or (5) Achieve compliance with this section by imposing an increase in cost sharing for an oral, intravenous, or injected anticancer medication covered under the policy on and following May 1, 2012. (c) Nothing in this section may be interpreted to prohibit an insurer from requiring prior authorization for any anticancer treatment. (d) Nothing in this section may be interpreted to require coverage for anticancer medication.

Del. Code tit. 18, § 3338B Coverage of drugs approved for treatment of certain cancers [For application of this section, see 81 Del. Laws, c. 180, §§ 3 and 4; 84 Del. Laws, c. 338, 3].

(a) No individual policy or contract of health insurance, or certificate issued thereunder, which is delivered, issued for delivery, renewed, modified, altered, or amended in this State by any health insurer, health service corporation or health maintenance organization that directly or indirectly covers the treatment of cancer shall limit or exclude coverage for a drug approved by the United States Food and Drug Administration by mandating that the insured shall first be required to fail to successfully respond to a different drug or drugs or prove a history of failure of a different drug or drugs; provided, however that the use of such drug or drugs is consistent with best practices for the treatment of stage 4 advanced, metastatic cancer or, in the case of other cancers, the use of the drug is supported by national clinical guidelines, national standards of care, or peer reviewed medical literature for the treatment of the cancer, or in the case of targeted therapy, the target at issue. (b) No individual policy or contract of health insurance, or certificate issued thereunder, which is delivered, issued for delivery, renewed, modified, altered, or amended in this State by any health insurer, health service corporation, or health maintenance organization that directly or indirectly cover the associated conditions of metastatic cancer shall limit or exclude coverage for drugs approved by the United States Food and Drug Administration by mandating that the insured shall first be required to fail to successfully respond to a different drug or drugs or prove a history of failure of a different drug or drugs; provided, however that the use of such drug is consistent with best practices for the treatment of the associated conditions of metastatic cancer and is supported by national clinical guidelines, national standards of care, or peer reviewed medical literature. (c) For purposes of this section, “associated conditions” mean the symptoms or side effects associated with metastatic cancer or its treatment and which, in the judgment of the health-care practitioner, further jeopardizes the health of a patient if left untreated.

Del. Code tit. 18, § 3339 Refusal to contract.

(a) An insurer shall not refuse to contract with or compensate for covered services a participating or contracting healthcare provider solely because that provider has in good faith communicated with 1 or more of the provider’s current, former or prospective patients regarding the provisions, terms or requirements of the insurer’s products or services as they relate to the needs of that provider’s patients. (b) An insurer that proposes to terminate or not renew a contract with a professional health-care provider shall give a minimum of 60 days written notice thereof to the provider prior to the effective date of the termination of the contract. This notice shall include a statement of the provider’s right to request a written explanation and to request an internal administrative review within 20 days. For purposes of this section, “provider” shall mean a health-care professional licensed pursuant to Title 24. (c) Upon the request of a provider who has received notice pursuant to subsection (b) of this section, an insurer shall provide written explanation by certified or registered mail of the reasons for the proposed termination or nonrenewal (unless such explanation has already been provided), and an opportunity for an internal administrative review of the decision to terminate. The provider’s request for written explanation and administrative review must be made within 20 days after receipt of the insurer’s notice of termination or nonrenewal. The insurer shall provide the written explanation and administrative review not less than 20 days after receipt of the provider’s request for same. (d) A provider who reasonably believes than an insurer’s decision to terminate or not renew a contract was solely based on reasons prohibited pursuant to subsection (a) of this section may request that this concern be addressed in the written explanation and administrative review provided by the insurer. Upon request, such a provider shall submit to the insurer a list of the insurer’s enrollees with whom the provider has communicated and upon whom the provider relies to support his or her belief and a statement of the nature of the information provided to each enrollee that is protected by this section. (e) If an insurer collects and maintains professional profiling data and the written explanation provided pursuant to subsection (c) of this section states that the insurer used such data to evaluate the performance or practice of the provider, this data shall be provided to the provider and be discussed during the administrative review pursuant to subsection (c) of this section. Data provided by an insurer pursuant to this section shall be confidential and shall not be disclosed by a provider or an insurer to third parties without the consent of the other party, except such data may be disclosed to a party’s attorney or as otherwise required by law. (f) This section shall not apply to a decision by an insurer to terminate or renew a provider’s contract because of breach of contract, loss of professional liability insurance, indictment or arrest or conviction for a felony or crime of moral turpitude, final internal disciplinary action (excluding judicial appeals) by a hospital, licensing board or other governmental agency that impairs the provider’s ability to practice or clinical privileges, failure to meet the minimum requirements for participation in the insurer’s plan, as previously disclosed to the provider, adjudication of fraud or in cases involving imminent harm to patient care. (g) Nothing in this section shall be construed to prohibit an insurer from terminating or not renewing a provider’s contract with or without cause for economic reasons or any other reason not prohibited by subsection (a) of this section, but a written explanation of the reasons for the proposed termination or nonrenewal must be provided pursuant to subsection (c) of this section. (h) This section shall not be deemed to create a private cause of action as a result of an insurer’s termination or nonrenewal of a provider’s contract. This subsection shall not abrogate any cause of action or remedy to which a provider may have a right pursuant to contract. (i) Any insurer who violates the provisions of this section may be subject to the administrative orders and penalties imposable for a violation of Chapter 23 of this title as specified in § 2308(a)(1) and (a)(2) of Title 18. (j) Providers, insurers and their respective employees, agents, attorneys and other representatives who have acted in good faith while participating in the written explanation or administrative review provided pursuant to subsection (c) of this section, shall have immunity and shall not be held liable as a result of any such participation in a case alleging slander, libel, defamation or in any other private cause of action. Such persons shall be presumed to have acted in good faith in the absence of evidence of malice or wilful misconduct.

Del. Code tit. 18, § 3340 Child abuse or neglect — Individual coverage.

No individual policy or contract, or certificate issued thereunder, of health insurance which provides medical coverage for a child and which (1) covers a child who resides in this State, or (2) is delivered or issued for delivery within the State, shall limit medical insurance coverage for any child referred by the Division of Family Services or law enforcement agency for suspected child abuse or neglect, including requiring referral by a primary physician.

Del. Code tit. 18, § 3341 Newborns and mothers health protection.

A carrier offering a health benefit plan shall comply with the provisions of 42 U.S.C. § 300gg-51 and any subsequent changes in federal law.

Del. Code tit. 18, § 3342 Obstetrical and gynecological coverage.

(a) This section applies to every individual policy or contract of health insurance, or certificate issued thereunder, which is delivered or issued for delivery in this State that requires an insured, participant, policyholder, subscriber, or beneficiary to designate a participating primary care provider. (b) Any such policy or contract shall permit each female enrolled insured, participant, policyholder, subscriber or beneficiary to designate a participating, in-network, obstetrician-gynecologist as the enrollee’s primary care provider if: (i) the obstetrician-gynecologist meets the standards established by the insurance plan for primary care providers; (ii) the obstetrician-gynecologist requests that the insurer makes the obstetrician-gynecologist available for designation as a primary care provider; (iii) the obstetrician-gynecologist agrees to accept the payment terms applicable under the plan to primary care providers for services other than obstetrician-gynecological services; and (iv) the obstetrician-gynecologist agrees to abide by all other terms and conditions applicable to primary care physicians under the plan generally. (c) If a female enrolled insured, participant, policyholder, subscriber or beneficiary has designated a primary care provider who is not an obstetrician-gynecologist, then the policy or contract shall not require as a condition to the coverage of the services of a participating in-network obstetrician-gynecologist that a female enrollee first obtain a referral from another primary care physician, and shall permit the female enrolled insured, participant, policyholder, subscriber or beneficiary to have direct access to the health-care services of an in-network obstetrician-gynecologist participating in the plan, within the benefits provided under that plan. In such cases the obstetrician-gynecologist shall consult with the primary care physician with respect to the care given and any follow-up care, and the plan may require a visit to the primary care physician, if necessary, before the patient may be directed to another specialty provider, or for inpatient hospitalization or outpatient surgical procedures. (d) For purposes of this section, “health-care services” means the full scope of medically necessary services provided by the participating obstetrician-gynecologist within the benefits provided under that plan. (e) This section shall not be construed to require an individual obstetrician-gynecologist to accept primary care physician status if the obstetrician-gynecologist does not wish to be designated as a primary care physician, nor to interfere with the credentialing and other selection criteria usually applied by a health benefit plan with respect to other physicians within its network. (f) Any such policy or contract may not impose a copayment, coinsurance requirement, or deductible for directly accessed obstetric and gynecologic services as required in this section, unless such additional cost sharing is imposed for access to health-care practitioners for other types of health-care services. (g) If a policy or contract limits an insured’s access to a network of participating providers for other health-care services, then it may limit access for obstetric and gynecologic services, but the policy or contract shall include in all its provider networks sufficient numbers of obstetrician-gynecologists to accommodate the direct access needs of their female enrollees. (h) Each such policy or contract shall provide notice to female enrolled participants, policyholders, subscribers and beneficiaries regarding the coverage required by this section. The notice shall be in writing, printed in type not less than 8-point, and prominently positioned in any literature or correspondence, including benefit handbooks and enrollment materials. Policies or contracts shall include an explanation of any voluntary process of preauthorization of services available to female enrollees and obstetrician-gynecologists. The enrollee handbook explanation shall include information regarding any limitation to direct access, including, but not limited to, a closed network of providers, or any limitation on access to an obstetrician-gynecologist based on a female’s choice of primary care provider. (i) (1) For purposes of this subsection: a. “Iatrogenic infertility” means an impairment of fertility due to surgery, radiation, chemotherapy, or other medical treatment. b. “Infertility” means a disease or condition that results in impaired function of the reproductive system whereby an individual is unable to procreate or to carry a pregnancy to live birth, including the following: 1. Absent or incompetent uterus. 2. Damaged, blocked, or absent fallopian tubes. 3. Damaged, blocked, or absent male reproductive tract. 4. Damaged, diminished, or absent sperm. 5. Damaged, diminished, or absent oocytes. 6. Damaged, diminished, or absent ovarian function. 7. Endometriosis. 8. Hereditary genetic disease or condition that would be passed to offspring. 9. Adhesions. 10. Uterine fibroids. 11. Sexual dysfunction impeding intercourse. 12. Teratogens or idiopathic causes. 13. Polycystic ovarian syndrome. 14. Inability to become pregnant or cause pregnancy of unknown etiology. 15. Two or more pregnancy losses, including ectopic pregnancies. 16. Uterine congenital anomalies, including those caused by diethylstilbestrol (“DES”). c. “Standard fertility preservation services” means procedures consistent with established medical practices and professional guidelines published by professional medical organizations, including the American Society for Clinical Oncology and the American Society for Reproductive Medicine. (2) 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 and that provide for medical or hospital expenses shall include coverage for fertility care services, including in vitro fertilization services for individuals who suffer from a disease or condition that results in the inability to procreate or to carry a pregnancy to live birth and standard fertility preservation services for individuals who must undergo medically necessary treatment that may cause iatrogenic infertility. Such benefits must be provided to covered individuals, including covered spouses and covered nonspouse dependents, to the same extent as other pregnancy-related benefits and include the following: a. Intrauterine insemination. b. Assisted hatching. c. Cryopreservation and thawing of eggs, sperm, and embryos. d. Cryopreservation of ovarian tissue. e. Cryopreservation of testicular tissue. f. Embryo biopsy. g. Consultation and diagnostic testing. h. Fresh and frozen embryo transfers. i. Six completed egg retrievals per lifetime, with unlimited embryo transfers in accordance with the guidelines of the American Society for Reproductive Medicine, using single embryo transfer (“SET”) when recommended and medically appropriate. j. In vitro fertilization (“IVF”), including IVF using donor eggs, sperm, or embryos, and IVF where the embryo is transferred to a gestational carrier or surrogate. k. Intra-cytoplasmic sperm injection (“ICSI”). l . Medications. m. Ovulation induction. n. Storage of oocytes, sperm, embryos, and tissue. o. Surgery, including microsurgical sperm aspiration. p. Medical and laboratory services that reduce excess embryo creation through egg cryopreservation and thawing in accordance with an individual’s religious or ethical beliefs. (3) An individual qualifies for coverage under this subsection if all of the following requirements are met: a. A board-certified or board-eligible obstetrician-gynecologist, subspecialist in reproductive endocrinology, oncologist, urologist, or andrologist verifies that the covered individual is diagnosed with infertility or is at risk of iatrogenic infertility. b. When the covered individual is diagnosed with infertility, the covered individual has not been able to obtain a successful pregnancy through reasonable effort with less costly infertility treatments covered by the policy, contract, or certificate, except as follows: 1. No more than 3 treatment cycles of ovulation induction or intrauterine inseminations may be required before in vitro fertilization services are covered. 2. If IVF is medically necessary, no cycles of ovulation induction or intrauterine inseminations may be required before in vitro fertilization services are covered. 3. IVF procedure must be performed at a practice that conforms to American Society for Reproductive Medicine and American Congress of Obstetricians and Gynecologists guidelines. c. For IVF services, retrievals are completed before the individual is 45 years old and transfers are completed before the individual is 50 years old. (4) A policy, contract, or certificate may not impose any exclusions, limitations, or other restrictions on coverage of fertility medications that are different from those imposed on any other prescription medications, nor may it impose deductibles, copayments, coinsurance, benefit maximums, waiting periods, or any other limitations on coverage for required fertility care services, which are different from those imposed upon benefits for services not related to infertility. (5) A policy, contract, or certificate is not required to cover experimental fertility care services, monetary payments to gestational carriers or surrogates, or the reversal of voluntary sterilization undergone after the covered individual successfully procreated with the covered individual’s partner at the time the reversal is desired.

Del. Code tit. 18, § 3342A Contraceptive coverage.

(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) “FDA” means the Food and Drug Administration. (3) a. “Health benefit plan” means any hospital or medical policy or certificate, major medical expense insurance, health service corporation subscriber contract, or health maintenance organization subscriber contract. “Health benefit plan” does not include accident-only, credit, dental, vision, Medicaid plans, long-term care or disability income insurance, coverage issued as a supplement to liability insurance, worker’s compensation or similar insurance, or automobile medical payment insurance. b. “Health benefit plan” does not include policies or certificates of specified disease, hospital confinement indemnity, or limited benefit health insurance, if the carrier offering such policies or certificates has done the following: 1. Filed on or before March 1 of each year a certification with the Commissioner that contains the following statement and information: A. A statement from the carrier certifying that policies or certificates described in this paragraph are being offered and marketed as supplemental health insurance and not as a substitute for hospital or medical expense insurance or major medical expense insurance. B. A summary description of each policy or certificate described in this paragraph, including the average annual premium rates or range of premium rates in cases where premiums vary by age, gender, or other factors charged for such policies and certificates in this State. 2. In the case of a policy or certificate that is described in this paragraph (a)(3)b. and that is offered for the first time in this State on or after January 1, 1999, the carrier files with the Commissioner the information and statement required in this paragraph (a)(3)b. at least 30 days prior to the date such a policy or certificate is issued or delivered in this State. (4) “Therapeutic equivalent” means a contraceptive drug, device, or product that is all of the following: a. Approved as safe and effective. b. Pharmaceutically equivalent to another contraceptive drug, device, or product in that it contains an identical amount of the same active drug ingredient in the same dosage form and route of administration and meets compendial or other applicable standards of strength, quality, purity, and identity. c. Assigned, by the FDA, the same therapeutic equivalence code as another contraceptive drug, device, or product. (b) Carriers shall provide coverage for contraceptive methods in all health benefit plans delivered or issued for delivery in this State. Coverage for contraceptive methods must include all of the following: (1) All FDA-approved contraceptive drugs, devices, and other products as follows: a. If the FDA has approved 1 or more therapeutic equivalents of a contraceptive drug, device, or product, the health benefit plan is not required to include all such therapeutically equivalent versions in its formulary as long as at least 1 is included and covered without cost-sharing and in accordance with this section. b. If there is a therapeutic equivalent of a drug, device, or other product for an FDA-approved contraceptive method, the health benefit plan may provide coverage for more than 1 drug, device, or other product and may impose cost-sharing requirements as long as at least 1 drug, device, or other product for that method is available without cost-sharing. If, however, an individual’s attending provider recommends a particular FDA-approved contraceptive based on a medical determination with respect to that individual, regardless of whether the contraceptive has a therapeutic equivalent, the health benefit plan shall provide coverage for the prescribed contraceptive drug, device, or product without cost-sharing. c. The health benefit plan is not required to provide coverage for male condoms. (2) FDA-approved contraception available over-the-counter, including emergency contraception, whether with or without a prescription, or dispensed consistent with the requirements of Chapter 25 of Title 24. (3) A prescription for contraceptives intended to last for no more than a 12-month period which may be dispensed all at once or over the course of the 12-month period, regardless of whether the covered individual was enrolled in the health benefit plan under this chapter at the time the prescription contraceptive was first dispensed. (4) Voluntary female sterilization procedures. (5) Patient education and counseling on contraception. (6) Follow-up services related to the drugs, devices, products, and procedures covered under this subsection, including management of side effects, counseling for continued adherence, and device insertion and removal. (7) Immediate postpartum insertion of long-acting reversible contraception. (c) (1) Coverage provided under this section is not subject to any deductible, coinsurance, copayment, or any other cost-sharing requirement, except under paragraph (b)(1) of this section or as otherwise required under federal law. Coverage offered under this section may not impose unreasonable restrictions or delays in the coverage, except that reasonable medical management techniques may be applied to coverage within a method category, as defined by the FDA, but not across types of methods. (2) Coverage provided to a covered individual under this section shall be the same for the covered individual’s covered spouse and covered dependents. (d) This section does not preclude coverage for contraceptive drugs, devices, products, and procedures as prescribed by a provider for reasons other than contraceptive purposes, including decreasing the risk of ovarian cancer, eliminating symptoms of menopause, or providing contraception that is necessary to preserve the life or health of the covered individual. (e) The plan is not required under this section to cover experimental or investigational treatments.

Del. Code tit. 18, § 3342B Primary care coverage [For application of this section, see 81 Del. Laws, c. 392, § 12].

(a) For purposes of this section: (1) a. “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. b. “Carrier” does not mean 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 1397aa. et seq.), known as Medicare, Medicaid, or any other similar coverage under state or federal governmental plans. (2) “Chronic care management” means the services in the Chronic Care Management Services Program, as administered by the Centers for Medicare and Medicaid Services, and includes Current Procedural Terminology (“CPT”) codes 99487, 99489, and 99490. (3) “Medicare” means the federal Medicare Program (U.S. Public Law 89-87, as amended) (42 U.S.C. § 1395 et seq.). (4) “Primary care” means health care provided by a physician or an individual licensed under Title 24 to provide health care, with whom the patient has initial contact and by whom the patient may be referred to a specialist and includes family practice, pediatrics, internal medicine, and geriatrics. (b) (1) A carrier shall provide coverage for chronic care management and primary care at a reimbursement rate that is not less than the Medicare reimbursement for comparable services. (2) This subsection applies to an individual health insurance policy, plan, or contract that is delivered, issued for delivery, or renewed by a carrier on or after January 1, 2019. (3) A carrier shall do the following: a. By 2022, spend at least 7% of its total cost of medical care on primary care. b. By 2023, spend at least 8.5% of its total cost of medical care on primary care. c. By 2024, spend at least 10% of its total cost of medical care on primary care. d. By 2025, spend at least 11.5% of its total cost of medical care on primary care. e. By 2026 and each year thereafter, spend at least 11.5%, 5% of which must be via prospective primary care management payments, of its total cost of medical care on primary care. (c) Coverage for chronic care management must not be subject to patient deductibles, copayments, or fees. (d) If a comparable Medicare reimbursement rate is not available, a carrier shall reimburse for services at the rates generally available under Medicare for services such as office visits and prolonged preventive services, which may be further delineated by regulation. (e) (1) The Department shall arbitrate disagreements regarding rates under this section. The parties must pay the cost of the arbitration. (2) The Department shall adopt regulations to implement the requirements of this subsection no later than March 31, 2019. (f) The provisions of this section may not be waived by contract. Any contractual arrangement in conflict with the provisions of this section or that purports to waive any requirements of this section is void. (g) (1) A carrier shall offer value-based care programs that meet the program design element requirements issued by the Department by the first full plan year following the Department’s promulgation of regulations pursuant to § 334 of this title. (2) A carrier may not deny a contracted provider the opportunity to participate in an offered value-based care program if the provider is willing to accept the terms and conditions established for other providers as a condition of program participation. (h) In calculating total cost of medical care for purposes of this section, the Commissioner shall, by regulation, authorize the exclusion of high-cost claims and may authorize the exclusion of other costs actually incurred by carriers.

Del. Code tit. 18, § 3343 Insurance coverage for serious mental illness [For application of this section, see 81 Del. Laws, c. 29, § 3; and 82 Del. Laws, c. 199, § 3] [Effective until Jan. 1, 2028].

(a) Definitions. — For purposes of this section: (1) “ASAM criteria” means the comprehensive set of guidelines for placement, continued stay, and transfer or discharge of patients with addiction established by the American Society of Addiction Medicine (“ASAM”) for use in determining medically necessary treatment. (2) “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. (3) “Drug and alcohol dependencies” means substance abuse disorder or the chronic, habitual, regular, or recurrent use of alcohol, inhalants, or controlled substances as identified in Chapter 47 of Title 16. (4) “FDA” means the U.S. Food and Drug Administration. (5) “Health benefit plan” means any hospital or medical policy or certificate, major medical expense insurance, health service corporation subscriber contract, or health maintenance organization subscriber contract. Health benefit plan does not include accident-only, credit, dental, vision, Medicaid plans, long-term care or disability income insurance, coverage issued as a supplement to liability insurance, worker’s compensation or similar insurance, or automobile medical payment insurance. “Health benefit plan” shall not include policies or certificates of specified disease, hospital confinement indemnity, or limited benefit health insurance, provided that the carrier offering such policies or certificates complies with the following: a. The carrier files on or before March 1 of each year a certification with the Commissioner that contains the statement and information described in paragraph (a)(5)b. of this section. b. The certification required in paragraph (a)(5)a. of this section shall contain the following: 1. A statement from the carrier certifying that policies or certificates described in this paragraph are being offered and marketed as supplemental health insurance and not as a substitute for hospital or medical expense insurance or major medical expense insurance. 2. A summary description of each policy or certificate described in this paragraph, including the average annual premium rates (or range of premium rates in cases where premiums vary by age, gender, or other factors) charged for such policies and certificates in this State. c. In the case of a policy or certificate that is described in this paragraph and that is offered for the first time in this State on or after January 1, 1999, the carrier files with the Commissioner the information and statement required in paragraph (a)(5)b. of this section at least 30 days prior to the date such a policy or certificate is issued or delivered in this State. (6) “Medication-assisted treatment” means the use of FDA-approved medications, in combination with counseling and behavioral therapies, to provide a whole patient approach to the treatment of drug and alcohol dependencies. (7) “Serious mental illness” means any of the following biologically based mental illnesses: schizophrenia, bipolar disorder, obsessive-compulsive disorder, major depressive disorder, panic disorder, anorexia nervosa, bulimia nervosa, schizo affective disorder, and delusional disorder. The diagnostic criteria set out in the most recent edition of the Diagnostic and Statistical Manual of Mental Disorders shall be utilized to determine whether a beneficiary of a health benefit plan is suffering from a serious mental illness. (b) Coverage of serious mental illnesses and drug and alcohol dependencies. — (1) a. Carriers shall provide coverage for serious mental illnesses and drug and alcohol dependencies in all health benefit plans delivered or issued for delivery in this State. Coverage for serious mental illnesses and drug and alcohol dependencies must provide all of the following: 1. Inpatient coverage for the diagnosis and treatment of drug and alcohol dependencies. 2. Unlimited medically necessary treatment for drug and alcohol dependencies as required by the Mental Health Parity and Addiction Equity Act of 2008 (29 U.S.C. § 1185a) and determined by the use of the full set of ASAM criteria, in all of the following: A. Treatment provided in residential setting. B. Intensive outpatient programs. C. Inpatient withdrawal management. b. Subject to subsections (a), (c) through (f), and (h) of this section, no carrier may issue for delivery, or deliver, in this State any health benefit plan containing terms that place a greater financial burden on an insured for covered services provided in the diagnosis and treatment of a serious mental illness and drug and alcohol dependency than for covered services provided in the diagnosis and treatment of any other illness or disease covered by the health benefit plan, including terms for deductibles, co-pays, monetary limits, coinsurance factors, limits in the numbers of visits, limits in the length of inpatient stays, durational limits, or limits in the coverage of prescription medicines. (2) a. A health benefit plan that provides coverage for prescription drugs must provide coverage for the treatment of serious mental illnesses and drug and alcohol dependencies that includes immediate access, without prior authorization, to a 5-day emergency supply of prescribed medications covered under the health benefit plan for the medically necessary treatment of serious mental illnesses and drug and alcohol dependencies where an emergency medical condition, as defined in § 3349(e) of this title, exists, including a prescribed drug or medication associated with the management of opioid withdrawal or stabilization, except where otherwise prohibited by law. b. Coverage of an emergency supply of prescribed medications must include medication for opioid overdose reversal otherwise covered under the health benefit plan prescribed to a covered person. c. Coverage provided under this paragraph (b)(2) of this section may be subject to copayments, coinsurance, and annual deductibles that are consistent with those imposed on other benefits within the health benefit plan; provided, however, a health benefit plan must not impose an additional copayment or coinsurance on a covered person who received an emergency supply of the same medication in the same 30-day period in which the emergency supply of medication was dispensed. d. This paragraph (b)(2) of this section does not preclude the imposition of a copayment or coinsurance on the initial emergency supply of medication in an amount that is less than the copayment or coinsurance otherwise applicable to a 30-day supply of such medication, provided that the total sum of copayments or coinsurance for an entire 30-day supply of the medication does not exceed the copayment or coinsurance otherwise applicable to a 30-day supply of such medication. (3) A health benefit plan that provides coverage for prescription drugs must place at least 1 formulation of a medication-assisted treatment on the lowest tier of the drug formulary developed and maintained by the carrier, including each of the following: a. Buprenorphine. b. Naltrexone. c. Naloxone. d. A product containing both buprenorphine and naloxone. (4) A health benefit plan that provides coverage for prescription drugs must cover the fees associated with the administration or dispensing of methadone dispensed at an opioid treatment program as defined under 42 C.F.R. § 8.2. (c) Eligibility for coverage. — (1) Subject to the limitations under subsection (d) of this section, a health benefit plan may condition coverage of services provided in the diagnosis and treatment of a serious mental illness and drug and alcohol dependency on any of the following requirements: a. That the services must be rendered by a mental health professional licensed or certified by the State Board of Licensing including, but not limited to, psychologists, psychiatrists, social workers, and other such mental health professionals, or a drug and alcohol counselor who has been certified by the Delaware Certified Alcohol and Drug Counselors Certification Board, or in a mental health facility licensed by the State or in a treatment facility approved by the Department of Health and Social Services or the Bureau of Alcoholism and Drug Abuse as set forth in Chapter 22 of Title 16, or substantially similar licensing entities in other states. b. That the services must be medically necessary. c. That the services must be covered services subject to any administrative requirements of the health benefit plan. (2) A health benefit plan may further condition coverage of services provided in the diagnosis and treatment of a serious mental illness and drug and alcohol dependency in the same manner and to the same extent as coverage for all other illnesses and diseases is conditioned. Such conditions include precertification and referral requirements. (d) Benefit management. — (1) A carrier may, directly or by contract with another qualified entity, manage the benefit prescribed by subsection (b) of this section in order to limit coverage of services provided in the diagnosis and treatment of a serious mental illness and drug and alcohol dependency to those services that are deemed medically necessary as follows: a. The management of benefits for serious mental illnesses and drug and alcohol dependencies may be by methods used for the management of benefits provided for other medical conditions, or may be by management methods unique to mental health benefits, including pre-admission screening, prior authorization of services, utilization review, and the development and monitoring of treatment plans. b. A carrier may not impose precertification, prior authorization, pre-admission screening, or referral requirements for the diagnosis and medically necessary treatment of drug and alcohol dependencies, including inpatient treatment or on a prescription medication under paragraph (b)(3) of this section. c. The benefit prescribed by paragraph (b)(1) of this section may not be subject to concurrent utilization review during the first 14 days of any inpatient admission to a facility approved by a nationally recognized health-care accrediting organization or the Division of Substance Abuse and Mental Health, 30 days of intensive outpatient program treatment, or 5 days of inpatient withdrawal management, provided that the facility notifies the carrier of both the admission and the initial treatment plan within 48 hours of the admission. The facility shall perform daily clinical review of the patient, including the periodic consultation with the carrier to ensure that the facility is using the evidence-based and peer reviewed clinical review tool utilized by the carrier which is designated by the American Society of Addiction Medicine (“ASAM”) or, if applicable, any state-specific ASAM criteria, and appropriate to the age of the patient, to ensure that the inpatient treatment is medically necessary for the patient. d. Any utilization review of treatment provided under paragraph (b)(1) of this section may include a review of all services provided during such inpatient treatment, including all services provided during the first 14 days of such inpatient treatment, 30 days of intensive outpatient program treatment, or 5 days of inpatient withdrawal management; provided, however, the carrier may only deny coverage for any portion of the initial 14-day inpatient treatment on the basis that such treatment was not medically necessary if such inpatient treatment was contrary to the evidence-based and peer reviewed clinical review tool utilized by the carrier which is designated by ASAM or, if applicable, any state-specific ASAM criteria. e. A covered person does not have any financial obligation to the facility for any treatment under paragraph (b)(1) of this section other than any copayment, coinsurance, or deductible otherwise required under the health benefit plan. f. A carrier must authorize coverage of prescription medicine without imposing a step therapy requirement for at least 1 formulation of each prescription medication for medication-assisted treatment that is on each tier of the drug formulary developed and maintained by the carrier. (2) This section shall not be interpreted to require a carrier to employ the same benefit management procedures for serious mental illnesses and drug and alcohol dependencies that are employed for the management of other illnesses or diseases covered by the health benefit plan or to require parity or equivalence in the rate, or dollar value of, claims denied. (e) Exclusions. — This section does not apply to plans or policies not within the definition of health benefit plan, as set out in subsection (a) of this section. (f) Out of network services. — Where a health benefit plan provides benefits for the diagnosis and treatment of serious mental illnesses and drug and alcohol dependencies within a network of providers and where a beneficiary of the health benefit plan obtains services consisting of diagnosis and treatment of a serious mental illness and drug and alcohol dependency outside of the network of providers, this section shall not apply. The health benefit plan may contain terms and conditions applicable to out of network services without reference to this section. (g) Reporting requirements. — Each carrier must submit a report to the Delaware Health Information Network in conjunction with the Commissioner on or before July 1 2019, and any year thereafter during which the carrier makes significant changes to how it designs and applies its medical management protocols; the report must contain the following information: (1) A description of the process used to develop or select the medical necessity criteria for mental illness and drug and alcohol dependencies benefits and the process used to develop or select the medical necessity criteria for medical and surgical benefits. (2) Identification of all nonquantitative treatment limitations (NQTLs) that are applied to mental illness and drug and alcohol dependencies benefits and medical and surgical benefits within each classification of benefits; there may be no separate NQTLs that apply to mental illness and drug and alcohol dependencies benefits that do not also apply to medical and surgical benefits within any classification of benefits. (3) The results of an analysis that demonstrates that for the medical necessity criteria described in paragraph (g)(1) of this section and for each NQTL identified in paragraph (g)(2) of this section, as written and in operation, the processes, strategies, evidentiary standards, or other factors used in applying the medical necessity criteria and each NQTL to mental illness and drug and alcohol dependencies benefits within each classification of benefits are comparable to, and are applied no more stringently than, the processes, strategies, evidentiary standards, or other factors used in applying the medical necessity criteria and each NQTL to medical and surgical benefits within the corresponding classification of benefits; at a minimum, the results of the analysis shall: a. Identify the factors used to determine that an NQTL will apply to a benefit, including factors that were considered but rejected. b. Identify and define the specific evidentiary standards used to define the factors and any other evidence relied upon in designing each NQTL. c. Provide the comparative analyses, including the results of the analyses, performed to determine that the processes and strategies used to design each NQTL, as written, for mental illness and drug and alcohol dependencies benefits are comparable to, and are applied no more stringently than, the processes and strategies used to design each NQTL, as written, for medical and surgical benefits. d. Provide the comparative analyses, including the results of the analyses, performed to determine that the processes and strategies used to apply each NQTL, in operation, for mental illness and drug and alcohol dependencies benefits are comparable to, and applied no more stringently than, the processes or strategies used to apply each NQTL, in operation, for medical and surgical benefits. e. Disclose the specific findings and conclusions reached by the carrier that the results of the analyses above indicate that the carrier is in compliance with this section and the Mental Health Parity and Addiction Equity Act of 2008 [P.L. 104-204] and its implementing regulations, which includes 45 C.F.R. 146.136, 45 C.F.R. 147.160, and any other related federal regulations found in the Code of Federal Regulations. (4) Any information submitted to the Delaware Health Information Network and the Commissioner by a carrier that is considered proprietary by the carrier shall not be made public record. (5) The Insurance Commissioner shall retain the authority to enforce the provisions of this section. The provisions of this section shall not give rise to a private cause of action. (h) Nothing in this section shall be construed to limit or reduce any benefit, entitlement, or coverage conferred by § 3366 of this title including, but not limited to, provider and service eligibility. (i) This section does not apply to plans 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 1397aa et seq., known as Medicare, Medicaid, or any other coverage under a state or federal government plan.

Del. Code tit. 18, § 3344 Insurance coverage for diabetes.

(a) Every individual or group hospital service corporation contract, individual or group medical service corporation contract, individual or group health service corporation contract, individual health insurance policy, group health insurance policy and contract for health-care services that provides hospital services, outpatient services or medical expense benefits, provides coverage for prescription drugs; and is delivered, issued, executed or renewed in this State pursuant to Title 18 or is approved for issuance or renewal in this State by the Insurance Commissioner shall provide benefits to any subscriber or other person covered thereunder for expenses incurred for the following equipment and supplies for the treatment of diabetes, if recommended in writing or prescribed by a physician: insulin pumps, blood glucose meters and strips, urine testing strips, insulin, syringes, and pharmacological agents for controlling blood sugar. (b) The benefits required by this section shall be provided to the same extent as for any other sickness under the contract. (c) This section shall apply to all hospital service corporation contracts in which the hospital service corporation has reserved the right to change the premium. (d) The Insurance Commissioner may promulgate and periodically update a list of additional diabetes equipment and related supplies that are medically necessary for the treatment of diabetes and for which benefits shall be provided according to the provisions of this section. (e) This section shall apply to all contracts and policies issued, renewed, modified, altered, amended or reissued 90 days and thereafter from the date of enactment. (f) Nothing in this section shall apply to accident-only, specified disease, hospital indemnity, Medicare supplement long-term care, disability income or other limited benefit health insurance policies.

Del. Code tit. 18, § 3344B Cost sharing in prescription insulin drugs.

(a) For purposes of this section, “prescription insulin drug” means a drug containing insulin that is dispensed under Chapter 47 of Title 16 for the treatment of diabetes. (b) An individual health insurance policy, contract, or certificate that is delivered, issued for delivery, renewed, extended, or modified in this State that provides coverage for prescription insulin drugs must do all of the following: (1) Cap the total amount that a covered individual is required to pay for covered prescription insulin drugs at no more than $100 per month for each enrolled individual, regardless of the amount or types of insulin needed to fill the covered individual’s prescriptions. The $100 per month cap includes deductible payments and cost-sharing amounts charged once a deductible is met. (2) Include at least 1 formulation of each of the following types of prescription insulin drugs on the lowest tier of the drug formulary developed and maintained by the carrier: a. Rapid-acting. b. Short-acting. c. Intermediate-acting. d. Long-acting. (3) For purposes of paragraph (b)(2) of this section, the “lowest tier of the drug formulary” means either of the following: a. If the prescription insulin drug is a generic drug, the lowest tier for generic drugs. b. If the prescription insulin drug is a brand-name drug, the lowest tier for brand-name drugs. (c) Except as provided under paragraph (b)(1) of this section, 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) This section applies to all policies, contracts, or certificates issued, renewed, modified, altered, amended, or reissued after December 31, 2020.

Del. Code tit. 18, § 3344C Coverage for insulin pumps.

(a) For purposes of this section, “insulin pump” means a small, portable medical device that is approved by the U.S. Food and Drug Administration to provide continuous subcutaneous insulin infusion. (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 a medically-necessary insulin pump at no cost to a covered individual, including deductible payments and cost-sharing amounts charged once a deductible is met. (c) Except as provided under subsection (b) of this section, 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) This section does not apply to any of the following: (1) Accident-only, specified disease, hospital indemnity, Medicare supplement, long-term care, disability income, or other limited benefit health insurance policies. (2) A high deductible health plan if providing coverage under subsection (b) of this section would cause the plan to fail to be treated as a high deductible health plan under § 223(c)(2) of the Internal Revenue Code [26 U.S.C. § 223(c)(2)]. (3) A catastrophic health plan if providing coverage under subsection (b) of this section would cause the plan to fail to be treated as a catastrophic plan under § 1302(e) of the Patient Protection and Affordable Care Act, 42 U.S.C. § 18022(e). (e) This section applies to all policies, contracts, or certificates issued, renewed, modified, altered, amended, or reissued after December 31, 2021.

Del. Code tit. 18, § 3344D Cost sharing in diabetes equipment and supplies.

(a) For purposes of this section, “diabetes equipment and supplies” means blood glucose meters and strips, urine testing strips, syringes, continuous glucose monitors and supplies, and insulin pump supplies. (b) An individual health insurance policy, contract, or certificate that is delivered, issued for delivery, renewed, extended, or modified in this State that provides coverage for any diabetes equipment or supplies must cap the total amount that a covered individual is required to pay for diabetes equipment and supplies at no more than $35 per month for each enrolled individual, regardless of the amount or types of diabetes equipment or supplies needed to fill the individual’s prescriptions. The $35 per month cap includes deductible payments and cost-sharing amounts charged once a deductible is met, except that the $35 cap does not apply to deductible payments charged by high deductible health plans or catastrophic health plans. (c) Except as provided under subsection (b) of this section, 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) This section does not apply to any of the following: (1) Accident-only, specified disease, hospital indemnity, Medicare supplement, long-term care, disability income, or other limited benefit health insurance policies. (2) A high deductible health plan if providing coverage under subsection (b) of this section would cause the plan to fail to be treated as a high deductible health plan under § 223(c)(2) of the Internal Revenue Code (26 U.S.C. § 223(c)(2)). (3) A catastrophic health plan if providing coverage under subsection (b) of this section would cause the plan to fail to be treated as a catastrophic plan under § 1302(e) of the Patient Protection and Affordable Care Act, 42 U.S.C. § 18022(e). (e) This section applies to all policies, contracts, or certificates issued, renewed, modified, altered, amended, or reissued after December 31, 2023.

Del. Code tit. 18, § 3345 Annual pap smear coverage reimbursement.

All individual health insurance policies which are delivered or issued for delivery in this State by any health insurer, health service corporation, health maintenance organization or any health services and facilities reimbursement program operated by the State and which provide a benefit for outpatient services shall also provide a benefit for an annual benefit for 1 cervical cancer screening, known as a “pap smear,” for all females aged 18 and over. This section shall apply to all policies, contracts, certificates or programs issued, renewed, modified, altered, amended or reissued on or after January 1, 2001.

Del. Code tit. 18, § 3346 Colorectal cancer screening.

(a) Every individual health, sickness or accident insurance policy contract or certificate which is delivered or issued for delivery in this State by any health insurer, health service corporation or health maintenance organization shall provide coverage for colorectal cancer screening under any such policy, contract or plan delivered, issued for delivery, or renewed in this State on or after January 1, 2001. The terms “health, sickness or accident insurance policy contract or certificate” shall not include, unless specifically provided in the policy, the following types of insurance or combination thereof: accident only, fixed or hospital confinement indemnity, limited benefit, credit, vision, specified disease, Medicare supplement, Champus supplement, long-term care, disability income workers compensation or automobile medical payment. (b) Colorectal cancer screening covered by this section shall include: (1) For persons 50 years of age or older screening with an annual fecal occult blood test, flexible sigmoidoscopy or colonoscopy, or in appropriate circumstances radiologic imaging or other screening modalities, shall be provided as determined by the Secretary of Health and Social Services of this State after consideration of recommendations of the Delaware Cancer Consortium and the most recently published recommendations established by the American College of Gastroenterology, the American Cancer Society, the United States Preventive Task Force Services, for the ages, family histories and frequencies referenced in such recommendations and deemed appropriate by the attending physician. (2) For persons who are deemed at high risk for colon cancer because of: a. Family history of familial adenomatous polyposis; b. Family history of hereditary nonpolyposis colon cancer; c. Chronic inflammatory bowel disease; d. Family history of breast, ovarian, endometrial or colon cancer or polyps; or e. A background, ethnicity or lifestyle such that the health-care provider treating the participant or beneficiary believes that person is at elevated risk; screening with an annual fecal occult blood test, flexible sigmoidoscopy or colonoscopy, or in appropriate circumstances radiologic imaging or other screening modalities, shall be provided as determined by the Secretary of Health and Social Services of this State after consideration of recommendations of the Delaware Cancer Consortium and the most recently published recommendations established by the American College of Gastroenterology, the American Cancer Society, the United States Preventive Task Force Services for the ages, family histories and frequencies referenced in such recommendations and deemed appropriate by the attending physician. (3) For all persons covered pursuant to paragraph (b)(1) or (b)(2) of this section, colorectal cancer screening shall include the use of anesthetic agents, including general anesthesia, in connection with colonoscopies and endoscopies performed in accordance with generally-accepted standards of medical practice and all applicable patient safety laws and regulations, if the use of such anesthetic agents is medically necessary in the judgment of the treating physician.

Del. Code tit. 18, § 3346A Prostate cancer screening [For application of this section, see 84 Del. Laws, c. 511, § 4].

(a) For purposes of this section, “prostate screening” means a medically-necessary and clinically-appropriate method for the detection and diagnosis of prostate cancer, including a digital rectal exam and prostate specific antigen test, and associated laboratory work. (b) All individual health insurance policies, contracts, or certificates that are delivered, issued for delivery, renewed, extended, or modified in this State after December 31, 2025, shall provide coverage for prostate screenings at no cost to a covered individual, including deductible payments and cost-sharing amounts charged once a deductible is met. In accordance with the American Cancer Society guidelines, coverage shall begin at: (1) Age 50 for men at average risk of developing prostate cancer. (2) Age 45 for men at high risk for developing prostate cancer, including African American men and men who have a first-degree relative diagnosed with prostate cancer. (3) Age 40 for men at even higher risk for prostate cancer, including men who have more than 1 first-degree relative diagnosed with prostate cancer. (c) Except as provided under subsection (b) of this section, 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) 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. (2) The cost-sharing limitation under subsection (b) of this section does not apply to a catastrophic health plan to the extent this cost-sharing limitation would cause the plan to fail to be treated as a catastrophic plan under § 1302(e) of the Patient Protection and Affordable Care Act, 42 U.S.C. § 18022(e). (3) a. The cost-sharing limitation under subsection (b) of this section does not apply to a high deductible health plan to the extent this cost-sharing limitation would cause the plan to fail to be treated as a high deductible health plan under § 223(c)(2) of the Internal Revenue Code [26 U.S.C. § 223(c)(2)]. b. If the cost-sharing limitation under subsection (b) of this section would result in an enrollee becoming ineligible for a health savings account under federal law, this cost-sharing limitation only applies to a qualified high deductible health plan after the enrollee’s deductible has been met.

Del. Code tit. 18, § 3347 Required coverage for reconstructive surgery following mastectomies.

(a) All individual health insurance policies, contracts or certificates that are delivered or issued for delivery in this State by any health insurer, health service corporation or managed care organization which provide medical and surgical benefits with respect to a mastectomy shall provide, in a case of an insured, participant, policyholder, subscriber, and beneficiary who is receiving benefits in connection with such mastectomy, in a manner determined in consultation with the attending physician and the patient, coverage for: (1) All stages of reconstruction of the breast on which the mastectomy has been performed; (2) Surgery and reconstruction of the other breast to produce a symmetrical appearance; and (3) Prostheses and physical complications of mastectomy, including lymphedemas. Such coverage may be subject to annual deductibles and coinsurance provisions as may be deemed appropriate and as are consistent with those established for other benefits under the plan of coverage. Written notice of the availability of such coverage shall be delivered to the insured, participant, policyholder, subscriber and beneficiary upon enrollment and annually thereafter. (b) All individual health benefit plans shall provide notice to each insured, participant, policyholder, subscriber and beneficiary under such plan regarding the coverage required by this section in accordance herewith. Such notice shall be in writing and prominently positioned in any literature or correspondence made available or distributed by the plan and shall be transmitted: (1) In the next mailing made by the plan to the insured, participant, policyholder, subscriber and beneficiary; (2) As part of any yearly informational packet sent to the insured, participant, policyholder, subscriber and beneficiary; or (3) Not later than June 30, 2001, whichever is earliest. (c) An individual health benefit plan may not deny to a patient eligibility or continued eligibility to enroll or to renew coverage under the terms of the plan solely for the purpose of avoiding the requirements of this section, and may not penalize or otherwise reduce or limit the reimbursement of an attending provider, or provide incentives (monetary or otherwise) to an attending provider, or induce such provider to provide care to an individual insured, participant, policyholder, subscriber and beneficiary in a manner inconsistent with this section. (d) Nothing in this section shall be construed to prevent a health benefit plan from negotiating the level and type of reimbursement with a provider for care provided in accordance with this section.

Del. Code tit. 18, § 3348 Referrals.

(a) This section applies to every policy or contract of health insurance which is delivered or issued for delivery in this State, including each policy or contract issued by a health service corporation, and which designates network physicians or providers or preferred physicians or providers (hereinafter referred to collectively as “network providers”). In such circumstances, the non-network provider may not balance bill the insured. (b) All individual and group health insurance policies shall provide that if medically necessary covered services are not available through network providers, or the network providers are not available within a reasonable period of time, the insurer, on the request of a network provider, within a reasonable period, shall allow referral to a non-network physician or provider and shall reimburse the non-network physician or provider at a previously agreed-upon or negotiated rate. In such circumstances, the non-network physician or provider may not balance bill the insured. Such a referral shall not be refused by the insurer absent a decision by a physician in the same or a similar specialty as the physician to whom a referral is sought that the referral is not reasonably related to the provision of medically necessary services. (c) All individual and group health insurance policies which do not allow insureds to have direct access to health-care specialists shall establish and implement a procedure by which insureds can obtain a standing referral to a health-care specialist. (d) The procedure established under subsection (c) of this section: (1) Shall provide for a standing referral to a specialist if the insured’s network provider determines that the insured needs continuing care from the specialist; and (2) May require the insurer’s approval of an initial treatment plan designed by the specialist containing (i) a limit on the number of visits to the specialist, (ii) a time limit on the duration of the referral, and (iii) mandatory updates on the insured’s condition. Such approval shall not be withheld absent a decision by a qualified physician that the treatment sought in the treatment plan is not reasonably related to the appropriate treatment of the insured’s condition. Within the treatment period referred to in paragraph (d)(2) of this section, the specialist shall be permitted to treat the insured without a further referral from the insured’s network provider and may authorize such further referrals, procedures, tests and other medical services as the individual’s network provider would otherwise be permitted to provide or authorize, provided that such further referrals, procedures, tests and other medical services are part of treating the patient for the condition for which the patient was referred to the specialist. Referrals, procedures, tests, and other medical services referred to in this subsection shall be provided by network providers unless such services are not available through network providers, or the network providers are not available within a reasonable period of time. If services are not available through network providers, or the network providers are not available within a reasonable period of time, the out-of-network provider shall be reimbursed at an agreed-upon or negotiated rate. In such circumstances, the non-network provider may not balance bill the insured. (e) Nothing in this section shall prevent the operation of policy provisions involving deductibles or copayments.

Del. Code tit. 18, § 3349 Emergency care.

(a) This section applies to every policy or contract of health insurance, including each policy or contract issued by a health service corporation, which is delivered or issued for delivery in this State, and which designates network physicians or providers or preferred physicians or providers (hereinafter referred to collectively as “network providers”). However, this section applies only to conditions for which coverage is provided by those policies or contracts. (b) All individual and group health insurance policies shall provide that persons covered under those policies will be insured for emergency care services performed by nonnetwork providers at an agreed-upon or negotiated rate, regardless of whether the physician or provider furnishing the services has a contractual or other arrangement with the insurer to provide items or services to persons covered under the policies. In the event that the provider of emergency services and the insurer cannot agree upon the appropriate rate, the provider shall be entitled to those charges and rates allowed by the Insurance Commissioner or the Commissioner’s designee following an arbitration of the dispute. The Insurance Commissioner shall adopt regulations concerning the arbitration of such disputes. In such circumstances, the nonnetwork provider may not balance bill the insured. (c) Prior to a determination by the Insurance Commissioner (or the Commissioner’s designee) of those charges and rates allowed by the providers of emergency services pursuant to subsection (b) of this section, the insurer will pay directly to the non-network emergency care provider the highest allowable charge for each emergency care service allowed by the insurer for any other network or non-network emergency care provider during the full 12-month period immediately prior to the date of each emergency care service performed by the non-network provider. The Insurance Commissioner is authorized to adopt regulations concerning the provisions of this subsection (c). (d) Plans described in subsections (a) and (b) of this section shall cover: (1) Any medical screening examination or other evaluation medically required to determine whether an emergency medical condition exists; (2) Necessary emergency care services, including treatment and stabilization of an emergency medical condition; and (3) Services originated in a hospital emergency facility or comparable facility following treatment or stabilization of an emergency medical condition as approved by the insurer with respect to services performed by non-network providers, provided that the insurer is required to approve or disapprove coverage of poststabilization care as requested by a treating physician or provider within the time appropriate to the circumstances relating to the delivery of services and the condition of the patient, but in no case to exceed 1 hour from the time of the request. (e) Nothing in this section shall prevent the operation of policy provisions involving deductibles or copayments. As used in this section “emergency medical condition” means a medical or behavioral condition the onset of which is sudden, that manifests itself by symptoms of sufficient severity, including, but not limited to, severe pain, that a prudent layperson, possessing an average knowledge of medicine and health, could reasonably expect the absence of immediate medical attention to result in: (1) Placing the health of the person afflicted with such condition in serious jeopardy, or in the case of a behavioral condition, placing the health of such person or others in serious jeopardy; (2) Serious impairment to such person’s bodily functions; (3) Serious impairment or dysfunction of any bodily organ or part of such person; or (4) Serious disfigurement of such person. (f) This section shall not apply to services provided by a volunteer fire department recognized as such by the State Fire Prevention Commission. (g) The Insurance Commissioner shall establish a schedule of fees for arbitration. The nonprevailing party at arbitration shall reimburse the Commissioner for the expenses related to the arbitration process. Funds paid to the Insurance Commissioner under this subsection shall be placed in the arbitration fund and shall be used exclusively for the payment of appointed arbitrators. The Insurance Commissioner may, in the Commissioner’s discretion, impose a schedule of maximum fees that can be charged by an arbitrator for a given type of arbitration.

Del. Code tit. 18, § 3349A Required coverage for volunteer ambulance company services.

(a) For the purpose of this section: (1) “Ambulance run” means a volunteer ambulance company response to dispatched calls for service. (2) “Basic life support (BLS)” shall have the same meaning as set forth in § 9702 of Title 16. (3) “Volunteer ambulance company” means a nonprofit ambulance company that is certified by the State Fire Prevention Commission and is providing basic life support (BLS) services. (b) Every individual health insurance policy, contract, certificate, or plan which is delivered or issued for delivery in this State by any health insurer, health service corporation, health maintenance organization, or managed care organization shall include coverage of not less than the cost of every ambulance run and associated basic life support (BLS) services provided by a volunteer ambulance company, inclusive of an allowance for uncompensated service, whether in the form of: (1) An allowable charge; (2) Through 100% payment; or (3) Any combination of the foregoing. (c) In the event that the volunteer ambulance company and the health insurer, health service corporation, health maintenance organization, or managed care organization cannot agree upon the allowable charge or the amount of payment to be made for an ambulance run and associated basic life support (BLS) services, then the volunteer ambulance company shall be entitled to those charges and rates allowed by the Insurance Commissioner or the Commissioner’s designee following an arbitration of the dispute. (1) The Insurance Commissioner shall adopt regulations concerning the arbitration of such disputes. (2) The Insurance Commissioner shall establish a schedule of fees for arbitration. The nonprevailing party at arbitration shall reimburse the Commissioner for the expenses related to the arbitration process. Funds paid to the Insurance Commissioner under this subsection shall be placed in the arbitration fund and shall be used exclusively for the payment of appointed arbitrators. The Insurance Commissioner may, in the Commissioner’s discretion, impose a schedule of maximum fees that can be charged by an arbitrator for a given type of arbitration. (d) Prior to the determination by the Insurance Commissioner, or the Commissioner’s designee, of the allowable charge or the amount of payment to be made for an ambulance run and associated basic life support (BLS) services, the health insurer, health service corporation, health maintenance organization, or managed care organization will pay directly to the volunteer ambulance company the charge assessed by the volunteer ambulance company for the run and basic life support (BLS) services provided, which shall not be subject to reimbursement after the Commissioner’s determination. The Insurance Commissioner is authorized to adopt regulations concerning the provisions of this subsection. (e) Nothing in this section shall prevent the operation of policy provisions involving deductibles or copayments. (f) This section shall not apply to policies that exclusively cover the following, and do not provide expense or reimbursement coverage for ambulance runs and associated basic life support (BLS) services provided by a volunteer ambulance company: (1) Hospital confinement indemnity; (2) Disability income; (3) Long-term care; (4) Medicare supplement; (5) Specified disease indemnity; (6) Individual and group supplemental health insurance; or (7) Other limited benefit policies, to the extent the policies do not cover ambulance runs and associated basic life support (BLS) services provided by a volunteer ambulance company. (g) Notwithstanding subsections (a)-(e) of this section, managed care organizations that contract with the State shall be exempt from this section with regard to that portion of their plans that serve Medicaid and Delaware Health Children Program recipients. (h) This section shall apply to all policies, contracts, certificates, or plans issued, renewed, modified, altered, amended, or reissued on or after January 1, 2015.

Del. Code tit. 18, § 3350 Prescription medication.

(a) This section applies to every policy or contract of health insurance, including each policy or contract issued by a health service corporation, which is delivered or issued for delivery in this State and which provides coverage for outpatient prescription drugs. (b) Every policy or contract of health insurance described in subsection (a) of this section shall provide coverage for any outpatient drug prescribed to treat a covered person for a covered chronic, disabling or life-threatening illness if the drug: (1) Has been approved by the Food and Drug Administration for at least 1 indication; and (2) Is recognized for treatment of the indication for which the drug is prescribed in: a. A prescription drug reference compendium approved by the Insurance Commissioner for purposes of this section; or b. Substantially accepted peer reviewed medical literature. (c) Coverage of a drug required by this section shall include coverage of medically necessary services associated with administration of the drug. (d) This section does not require coverage for: (1) Medication that may be obtained without a physician’s prescription; (2) Experimental drugs not otherwise approved for the proposed use or indication by the Food and Drug Administration; or (3) Any disease, condition, service or treatment that is excluded from coverage under the policy. (e) Nothing in this section shall prevent the operation of policy provisions involving deductibles, coinsurance, allowable charge limitations, maximum dollar policy limitations or coordination of benefits.

Del. Code tit. 18, § 3350B Copayment or coinsurance for prescription drugs limited [For application of this section, see 82 Del. Laws, c. 57, § 3 and 83 Del. Laws, c. 522, § 4].

(a) Definitions. — (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. (2) “Contract price” means the lowest price a pharmacy is paid for the acquisition of a prescription drug based on a contract that a pharmacy has with a carrier or pharmacy benefits manager. “Contract price” includes a dispensing fee set by a contract between a pharmacy and a carrier or pharmacy benefits manager. (3) “Cost-sharing requirement” means any copayment, coinsurance, deductible, or annual limitation on cost-sharing (including a limitation subject to 42 U.S.C. §§ 18022(c) and 300gg-6(b)), required by or on behalf of an enrollee in order to receive a specific health care service, including a prescription drug, covered by a health benefit plan. (4) “Health benefit plan” means as defined in § 3343 of this title. (5) “Health care service” means an item or service furnished to any individual for the purpose of preventing, alleviating, curing, or healing human illness, injury, or physical disability. (6) “Person” means as defined in § 102 of this title. (7) “Pharmacy” means as defined in § 2502 of Title 24. (8) “Pharmacy benefit manager” means as defined under § 3302A of this title. (b) Application. — This section applies to a carrier that provides coverage, either directly or through a pharmacy benefits manager, for prescription drugs under a health insurance policy, health benefit plan, or contract that is issued or delivered in this State. (c) A carrier subject to this section may not impose a copayment or coinsurance requirement for a covered prescription drug that exceeds the lesser of one of the following: (1) The applicable copayment or coinsurance that would apply for the prescription drug in the absence of this section. (2) The amount an individual would pay for the prescription drug if the individual were paying the usual and customary price. (3) The contract price for the prescription drug. (d) Cost-sharing calculation. — When calculating an enrollee contribution to any applicable cost-sharing requirement, a carrier shall include any cost-sharing amounts paid by the enrollee or on behalf of the enrollee by another person. If under federal law, application of this requirement would result in health savings account ineligibility under § 223 of the federal Internal Revenue Code [26 U.S.C. § 223], this requirement shall apply for health savings account-qualified high deductible health plans with respect to the deductible of such a plan after the enrollee has satisfied the minimum deductible under [26 U.S.C.] § 223, except with respect to items or services that are preventive care pursuant to [26 U.S.C.] § 223(c)(2)(C) of the federal Internal Revenue Code, in which case the requirements of this subsection shall apply regardless of whether the minimum deductible under [26 U.S.C.] § 223 has been satisfied. (e) Rule-making. — The Insurance Commissioner may promulgate rules and regulations as may be necessary or appropriate to implement and administer this section.

Del. Code tit. 18, § 3351 Clinical trials.

(a) This section applies to every policy or contract of health insurance, including each policy or contract issued by a health service corporation, which is delivered or issued for delivery in this State. (b) Definitions. — (1) “Clinical trials,” for purposes of this section, include clinical trials that are approved or funded by use of the following entities: a. One of the National Institutes of Health (NIH); b. An NIH cooperative group or center which is a formal network of facilities that collaborate on research projects and have an established NIH-approval peer review program operating within the group, including, but not limited to, the NCI Clinical Cooperative Group and the NCI Community Clinical Oncology Program; c. The federal Departments of Veterans’ Affairs or Defense; d. An institutional review board of an institution in this State that has a multiple project assurance contract approval by the Office of Protection for the Research Risks of the NIH; and e. A qualified research entity that meets the criteria for NIH Center Support grant eligibility. (2) “Routine patient care costs,” as used in this section, include all items and services that are otherwise generally available to a qualified individual that are provided in the clinical trial except: a. The investigational items or service itself; b. Items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patients; and c. Items and services customarily provided by the research sponsors free of charge for any enrollee in the trial. (3) Any clinical trial receiving coverage for routine costs under this section must meet the following requirements: a. The subject or purpose of the trial must be the evaluation of an item or service that falls within the covered benefits of the policy and is not specifically excluded from coverage. b. The trial must not be designed exclusively to test toxicity or disease pathophysiology. c. The trial must have therapeutic intent. d. Trials of therapeutic interventions must enroll patients with diagnosed disease. e. The principal purpose of the trial is to test whether the intervention potentially improves the participant’s health outcomes. f. The trial is well supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use. g. The trial does not unjustifiably duplicate existing studies. h. The trial is in compliance with federal regulations relating to the protection of human subjects. (c) Every policy described in subsection (a) of this section, including each policy or contract issued by a health service corporation, shall provide coverage for routine patient care costs as defined in paragraph (b)(2) of this section for covered persons engaging in clinical trials for treatment of life-threatening diseases. Nothing in this section, however, independently requires coverage for expense of such clinical trials which are otherwise not covered under the policy or contract.

Del. Code tit. 18, § 3351B Experimental treatment coverage.

(a) No individual policy or contract of health insurance, or certificate issued thereunder, which is delivered, issued for delivery, or renewed in this State by any health insurer, health service corporation, or health maintenance organization shall deny coverage, payment, or reimbursement for a National Coverage Determination Service on the basis that the service, item, test, or treatment is experimental or investigational. (b) “National Coverage Determination Service” as used in this section shall mean a service, item, test, or treatment which has been determined to be covered nationally by the Secretary of the U.S. Department of Health and Human Services pursuant to the Social Security Act, § 1869 (f) [42 U.S.C. § 1395ff].

Del. Code tit. 18, § 3352 Newborn and infant hearing screening; coverage and reimbursement.

(a) Any individual health insurance policy which is delivered, issued for delivery, renewed, extended, or modified in this State by any health-care insurer and which provides coverage for a child shall be deemed to provide coverage for hearing loss screening tests of newborns and infants provided by a hospital before discharge. (b) The amount of reimbursement for newborn or infant hearing screening provided under such a policy shall be consistent with reimbursement of other medical expenses under the policy, including the imposition of co-payment, coinsurance, deductible, or any dollar limit or other cost-sharing provisions otherwise applicable under the policy.

Del. Code tit. 18, § 3353 Use of social security numbers on insurance cards.

(a) As used in this section, “insurance card” means a card that a person or entity provides to an individual so that the individual may present the card to establish the eligibility of the individual or the individual’s dependents to receive health, dental, optical, or accident insurance benefits, prescription drug benefits, or benefits under a managed care plan or a plan provided by a health maintenance organization, a health services plan corporation, or a similar entity. (b) No person or entity which provides an insurance card shall use an individual’s social security number as the identification number on that insurance card.

Del. Code tit. 18, § 3354 Supplemental coverage for children of insureds [For application of this section, see 79 Del. Laws, c. 99, § 19].

(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) “Covered person” means a person who claims to be entitled to receive benefits from a carrier. (3) “Dependent” means a covered person’s child by blood or by law who is less than 26 years of age. (b) If a carrier’s contract with a subscriber provides coverage for a covered person’s dependent under which coverage of the dependent terminates at a specific age before the dependent’s twenty-sixth birthday, the contract must nevertheless provide coverage to the dependent after that specific age until the dependent’s twenty-sixth birthday. (c) Subsection (b) of this section may not be construed to require: (1) Coverage for services provided to a dependent prior to May 30, 2007; (2) That an employer pay all or part of the cost of coverage for a dependent as provided pursuant to this section; or (3) Coverage for services rendered prior to a dependent’s election pursuant to subsection (e) of this section and payment of premium required under subsection (g) of this section. (d) A dependent covered by a covered person’s contract, where coverage under the contract’s language would terminate at a specific age before the dependent’s twenty-sixth birthday, may make a written election for coverage as a dependent pursuant to this section, until the dependent’s twenty-sixth birthday. The election must be made: (1) Within 30 days prior to the termination of coverage at the specific age provided in the contract’s language; (2) Within 30 days after meeting the requirements for dependent status as set forth in subsection (a) of this section, when coverage for the dependent under the contract’s language had previously terminated; or (3) During an open enrollment period, as provided pursuant to the contract, if the dependent meets the requirements for dependent status as set forth in subsection (a) of this section during the open enrollment period. Coverage for a dependent who makes a written election for coverage may not be conditioned upon or discriminate on the basis of lack of evidence of insurability. (e) Notwithstanding the time limitations imposed by subsection (d) of this section, until May 30, 2008, a dependent who qualifies for dependent status as set forth in subsection (a) of this section, but whose coverage as a dependent under a covered person’s contract terminated under the terms of the contract prior to May 30, 2007, may make a written election to reinstate coverage under that contract as a dependent pursuant to this section. (f) Coverage for a dependent who makes a written election for coverage pursuant to subsection (d) of this section consists of coverage which is identical to the coverage that would have been provided to that dependent had that dependent not been terminated from the contract due to the dependent’s age. (g) A covered person’s contract may require payment of a premium by the covered person or dependent, subject to any approvals required by Delaware law, for any period of coverage relating to a dependent’s written election for coverage pursuant to subsection (d) of this section. The payment may not exceed 102% of the applicable portion of the premium previously paid for that dependent’s coverage under the contract prior to the termination of coverage at the specific age provided in the contract. (h) The applicable portion of the premium previously paid for a dependent’s coverage under subsection (g) of this section is determined pursuant to regulations promulgated by the Department of Insurance, based upon the difference between the contract’s rating tiers for adult and dependent coverage or family coverage, as appropriate, and single coverage, or based upon any other formula or dependent rating tier which provides a substantially similar result and is considered appropriate by the Department of Insurance. (i) Coverage for a dependent provided pursuant to this section must be provided until the earlier of the following: (1) The dependent is no longer a dependent as defined in subsection (a) of this section; (2) The date on which coverage ceases under the contract by reason of a failure to make a timely payment of any premium required under the contract by the covered person or dependent for coverage provided pursuant to this section. The payment of any premium is considered to be timely if made within 30 days after the due date or within a longer period as provided for by the contract; or (3) The date upon which the employer under whose contract coverage is provided to a dependent ceases to provide coverage to the covered person. (j) Prominent notice regarding coverage for a dependent as provided pursuant to this section must be provided to a covered person by the carrier: (1) In the certificate of coverage prepared for covered persons by the carrier on or about the date of commencement of coverage; and (2) Upon each renewal, but at least once annually; and (3) By June 29, 2007.

Del. Code tit. 18, § 3355 Phenylketonuria (PKU) and other inherited metabolic diseases.

(a) Definitions. — In this section the following words shall have the meanings indicated: (1) “Inherited metabolic diseases” shall mean diseases caused by an inherited abnormality of biochemistry. The words “inherited metabolic diseases” shall also include any diseases for which the State screens newborn babies. (2) a. “Low protein modified formula or food product” means a formula or food product that is: 1. Specially formulated to have less than 1 gram of protein per serving; and 2. Intended to be used under the direction of a physician for the dietary treatment of an inherited metabolic disease. b. “Low protein modified food product” does not include a natural food that is naturally low in protein. (3) “Medical formula or food” means a formula or food that is: a. Intended for the dietary treatment of an inherited metabolic disease for which nutritional requirements and restrictions have been established by medical research; and b. Formulated to be consumed or administrated enterally under the direction of a physician. (b) Application of this section. — The provisions of this section shall apply to any health insurance contract that: (1) Provides coverage for a family member of the insured; (2) Is delivered or issued for delivery in the State. (c) A health insurance contract shall, under the family member coverage, include coverage for medical formulas and foods and low protein modified formulas and modified food products for the treatment of inherited metabolic diseases, if such medical formulas and foods or low protein modified formulas and food products are: (1) Prescribed as medically necessary for the therapeutic treatment of inherited metabolic diseases; and (2) Administered under the direction of a physician.

Del. Code tit. 18, § 3356 Required coverage for scalp hair prosthesis.

(a) Every individual health insurance policy, contract or certificate that is delivered or issued for delivery in this State by any health insurer, health service corporation or managed care organization which provide for medical or hospital expenses and also provide coverage for other prostheses, shall provide coverage for expenses for a scalp hair prosthesis worn for hair loss suffered as a result of alopecia areata, resulting from an autoimmune disease. Such coverage shall be subject to the same limitations and guidelines as other prostheses, provided that such coverage for alopecia areata shall not exceed $500 per year. (b) For purposes of this section: (1) “Prostheses” means artificial appliances used to replace lost natural structures. Prostheses include, but are not limited to, artificial arms, legs, breasts, or glass eyes. (2) “Scalp hair prosthesis” means an artificial substitute for scalp hair that is made specifically for a specific individual. (c) Such coverage may be subject to annual deductibles and co-insurance provisions as may be deemed appropriate and as are consistent with those established for other benefits under the plan of coverage. Written notice of the availability of such coverage shall be delivered to the insured, participant, policyholder, subscriber and beneficiary upon enrollment and annually thereafter. (d) All group and blanket health benefit plans shall provide notice to each insured, participant, policyholder, subscriber and beneficiary under such plan regarding the coverage required by this section in accordance herewith. Such notice shall be in writing and prominently positioned in any literature or correspondence made available or distributed by the plan and shall be transmitted as part of any yearly informational packet sent to the insured, participant, policyholder, subscriber and beneficiary.

Del. Code tit. 18, § 3357 Hearing aid coverage.

(a) For purposes of this section, the term “hearing aid” means any nonexperimental, wearable instrument or device designed for the ear and offered for the purpose of aiding or compensating for impaired human hearing, but excluding batteries, cords, and other assistive listening devices such as FM systems. (b) Every individual health insurance contract, including each policy or contract issued by a health service corporation, which is delivered, issued for delivery, or renewed in this State on or after January 1, 2009, shall provide coverage of up to $1000 per individual hearing aid, per ear, every 3 years, for children less than 24 years of age, covered as a dependent by the policy holder. (c) The insured may choose a hearing aid exceeding $1,000 and pay the difference in cost above the amount of coverage required by this section. Reimbursement shall be provided according to the respective principles and policies of the insurer. The insurer may require the policyholder to provide a prescription or show proof through other suitable documentation of the need for a hearing aid and nothing contained in this section shall preclude the insurer from conducting managed care, medical necessity, or utilization review or prevent the operation of such policy provisions as deductibles, coinsurance, allowable charge limitations, coordination of benefits or provisions restricting coverage to services by licensed, certified or carrier-approved providers or facilities. (d) This section does not apply to insurance coverage providing benefits for: (1) Hospital confinement indemnity; (2) Disability income; (3) Accident only; (4) Long-term care; (5) Medicare supplement; (6) Limited benefit health; (7) Specified diseased indemnity; (8) Sickness or bodily injury or death by accident, or both; and (9) Other limited benefit policies.

Del. Code tit. 18, § 3358 Dental services for children with a severe disability.

(a) Definitions. — As used in this section: (1) “Child with a severe disability” means a person under the age of 21 who, due to a significant mental or physical condition, illness, or disease, is likely to require specialized treatment or supports to secure effective access to dental care. The written certification of a child’s treating physician, advanced practice nurse, or licensed psychologist shall be sufficient to qualify a person as a “child with a severe disability.” (2) “Dental services” means the full range of diagnostic and treatment services within the scope of benefits available under the health insurance contract or policy. (b) Application of section. — This section applies to every individual health insurance contract, including each policy or contract issued by a health service corporation, which is delivered, issued for delivery, or renewed in this State which provides coverage for dental services for a child. (c) Payment authorization. — Every contract or policy described in subsection (b) of this section shall authorize payment to a licensed practitioner for dental services to a child with a severe disability irrespective of lack of contractual or network status. Unless otherwise negotiated with the practitioner in advance, such payment shall be in an amount at least equal to the insurer’s reasonable and customary compensation for the same or similar services in the same geographical area. A nonnetwork practitioner accepting payment under this section may not balance bill the insured. (d) Preservation of contract limits. — Nothing in this section shall prevent the application of contract or policy provisions involving deductibles, coinsurance, maximum dollar limitations or coordination of benefits, provided that such limits shall be applied using in-network standards. (e) Waiver. — The Commissioner may establish, by regulation, standards authorizing the issuance of a waiver to an insurer from application of this section. At a minimum, such waiver standards shall only permit a time-limited, renewable waiver upon submission of clear and convincing documentation of the numerical and geographical availability of in-network practitioners willing and able to effectively treat a child with a severe disability.

Del. Code tit. 18, § 3359 Health insurance; pharmacies; electronic reimbursement.

(a) This section shall apply to: (1) Insurers and nonprofit health service plans that provide, directly or through a pharmacy benefit manager, coverage for prescription drugs under health insurance policies or contracts that are issued or delivered in this State; and (2) Health maintenance organizations that provide, directly or through a pharmacy benefit manager, coverage for prescription drugs under contracts that are issued or delivered in this State. (b) If an entity subject to this section requires a pharmacy to submit a request for payment electronically, then the pharmacy or its designated agent may choose to be reimbursed electronically, and in that event the entity shall electronically reimburse such pharmacy and shall provide the appropriate payment data electronically, provided that the electing pharmacy agrees to, and can accept claims details for the payments electronically and provide accurate electronic funds transfer information to the entity making payments. (c) An entity subject to this section may not impose on a pharmacy a processing fee for the electronic reimbursement or for providing payment data electronically. (d) Subsequent to January 6, 2010, any pharmacy that requires electronic reimbursement under this section shall allow an entity 45 days to become compliant herewith from the date of the pharmacy’s initial request to commence electronic reimbursement between the parties.

Del. Code tit. 18, § 3359B Electronic medical (non-pharmaceutical) claims.

(a) This section shall apply to all claims for healthcare services that are submitted and are not covered by § 3359 of this title. (b) 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. (c) A carrier shall accept primary and secondary claims electronically from providers regardless of network status. (d) A carrier shall permit a provider to receive electronic remittance advice (ERA/835) files for claims payments upon the completion of the necessary agreements required by the carrier. (e) Any electronic claim shall be acknowledged by the carrier electronically no later than 2 business days following receipt of the claim to the entity submitting the claim.

Del. Code tit. 18, § 3360 Screening of infants and toddlers for developmental delays.

Del. Code tit. 18, § 3361 Limitations on preexisting condition limitations for minor children [Repealed].

Del. Code tit. 18, § 3362 Reimbursement for orthotic and prosthetic services.

(a) Definitions. — For purposes of this section: (1) “Federal reimbursement rates” means the current listed fee schedule from the Centers for Medicare and Medicaid Services, listing the current Healthcare Common Procedure Coding System (HCPCS) and the corresponding reimbursement rates. (2) “Orthosis” means a custom fabricated brace or support that is designed based on medical necessity. Orthosis does not include prefabricated or direct-formed orthotic devices or any of the following assistive technology devices: commercially available knee orthoses used following injury or surgery; spastic muscle-tone inhibiting orthoses; upper extremity adaptive equipment; finger splints; hand splints; wrist gauntlets; face masks used following burns; wheelchair seating that is an integral part of the wheelchair and not worn by the patient independent of the wheelchair; fabric or elastic supports; corsets; low-temperature formed plastic splints; trusses; elastic hose; canes; crutches; cervical collars; dental appliances; and any other similar devices, as determined Secretary of the Department of Health and Social Services, commonly carried in stock by a pharmacy, department store, or surgical supply facility. (3) “Orthotics” means the science and practice of evaluating, measuring, designing, fabricating, assembling, fitting, adjusting, or servicing, as well as providing the initial training necessary to accomplish the fitting of, an orthosis for the support, correction, or alleviation of neuromuscular or musculoskeletal dysfunction, disease, injury, or deformity. The practice of orthotics encompasses evaluation, treatment, and consultation; with basic observational gait and postural analysis, orthotists assess and design orthoses to maximize function and provide not only the support but also the alignment necessary to either prevent or correct a deformity or to improve the safety and efficiency of mobility, locomotion, or both. Orthotic practice includes providing continuing patient care in order to assess its effect on the patient’s tissues and to assure proper fit and function of the orthotic device through periodic evaluation. (4) “Prosthesis” means an artificial limb that is alignable or, in lower-extremity applications, capable of weight bearing. “Prosthesis” means an artificial medical device that is not surgically implanted and that is used to replace a missing limb, appendage, or other external human body part including an artificial limb, hand, or foot. The term does not include artificial eyes, ears, noses, dental appliances, ostomy products, or devices such as eyelashes or wigs. (5) “Prosthetics” means the science and practice of evaluation, measuring, designing, fabricating, assembling, fitting, aligning, adjusting, or servicing, as well as providing the initial training necessary to accomplish the fitting of, a prosthesis through the replacement of external parts of a human body lost due to amputation, congenital deformities, or abscesses. The practice of prosthetics also includes the generation of an image, form, or mold that replicates the patient’s body or body segment and that requires rectification of dimensions, contours, and volumes for use in the design and fabrication of a socket to accept a residual anatomic limb to, in turn, create an artificial appendage that is designed either to support body weight or to improve or restore function or cosmesis, or both. Involved in the practice of prosthetics is observational gait analysis and clinical assessment of the requirements necessary to refine and mechanically fix the relative position of various parts of the prosthesis to maximize function, stability, and safety of the patient. The practice of prosthetics includes providing and continuing patient care in order to assess the prosthetic device’s effect on the patient’s tissues and to assure proper fit and function of the prosthetic device through periodic evaluation. (b) Every individual health insurance contract, plan, or policy which is delivered, issued for delivery, or renewed in this State on or after January 1, 2012, and which provides medical coverage that includes coverage for physician services in a physician’s office, and every policy which provides major medical or similar comprehensive type coverage, shall provide reimbursement for orthotic and prosthetic devices at least equal to federal reimbursements rates provided for under federal laws for health insurance for the aged and disabled pursuant to 42 U.S.C. §§ 1395k, 1395l, and 1395m and 42 C.F.R. §§ 414.202, 414.210, 414.228, and 410.100, as applicable to this section. (c) A health insurance contract, plan, or policy may require prior authorization for orthotic and prosthetic devices in the same manner that prior authorization is required for any other covered benefit. (d) Covered benefits for orthotic or prosthetic devices shall be limited to the most appropriate model that adequately meets the medical needs of the patient. (e) The repair and replacement of orthotic or prosthetic devices also shall be covered subject to co-payments and deductibles, unless necessitated by misuse or loss. (f) An insurer may require, if coverage is provided through a managed care plan, that benefits mandated pursuant to this section be covered benefits only if the orthotic or prosthetic devices are provided by a vendor, and orthotic or prosthetic services are rendered by a provider, who is licensed by the State to provide orthotics and prosthetics. (g) 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) Limited benefit health; (7) Specified disease indemnity; (8) Sickness or bodily injury or death by accident or both; or (9) Other limited benefit policies.

Del. Code tit. 18, § 3363 Recommended immunizations and preventive services.

(a) This section applies to any health carrier providing coverage under an individual or group health benefit plan. (1) This section does not apply to grandfathered plan coverage. (2) For purposes of this section, “grandfathered plan coverage” means coverage provided by a health carrier in which an individual was enrolled on March 23, 2010, for as long as it maintains that status in accordance with federal regulations. (b) A health carrier shall provide coverage for the following items and services. A health carrier shall not impose any costs, such as a copayment, coinsurance or deductible with respect to the following items and services: (1) Except as otherwise provided in this section, evidence-based items or services that had a rating of “A” or “B” in the recommendations of the United States Preventive Services Task Force that were in effect on January 1, 2025, with respect to the individual involved. (2) Immunizations for routine use in children, adolescents and adults that were recommended by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention in effect on January 1, 2025, or other immunizations that were supported by national clinical guidelines or national standards of care in effect on January 1, 2025, with respect to the individual involved. For purposes of this paragraph, a recommendation from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention is considered in effect after it has been adopted by the Director of the Centers for Disease Control and Prevention, and a recommendation is considered to be for routine use if it is listed on the Immunization Schedules of the Centers for Disease Control and Prevention. (3) With respect to infants, children and adolescents, evidence-informed preventive care, and screenings provided for in comprehensive guidelines supported by the Health Resources and Services Administration in effect on January 1, 2025. (4) With respect to women, to the extent not described in paragraph (b)(1) of this section, evidence-informed preventive care and screenings provided for in comprehensive guidelines supported by the Health Resources and Services Administration in effect on January 1, 2025. (c) [Repealed.] (d) Other provisions of state or federal law may apply in connection with a health carrier’s ceasing to provide coverage for any such items or services including § 2715(d)(4) of the Public Health Service Act [42 U.S.C. § 300gg-15(d)(4)], which requires a health carrier to give 60 days’ advance notice to a covered person before any material modification will become effective. (e), (f) [Repealed.] (g) A health carrier may impose cost-sharing requirements with respect to an office visit if an item or service described in this section is billed separately or is tracked as individual encounter data separately from the office visit. (h) A health carrier shall not impose cost-sharing requirements with respect to an office visit if an item or service described in this section is not billed separately or is not tracked as individual encounter data separately from the office visit and the primary purpose of the office visit is the delivery of the item or service. (i) A health carrier may impose cost-sharing requirements with respect to an office visit if an item or service described in this section is not billed separately or is not tracked as individual encounter data separately from the office visit and the primary purpose of the office visit is not the delivery of the item or service. (j) Nothing in this section requires a health carrier that has a network of providers to provide benefits for items and services described herein that are delivered by an out-of-network provider. (k) Nothing in this section precludes a health carrier that has a network of providers from imposing cost-sharing requirements for items or services described herein that are delivered by an out-of-network provider. ( l ) Nothing in this section prohibits a health carrier from using reasonable medical management techniques to determine the frequency, method, treatment or setting for an item or service described herein to the extent not specified in the recommendation or guideline. (m) Nothing in this section prohibits a health carrier from providing coverage for items and services in addition to those recommended by the United States Preventive Services Task Force or the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention, or provided by guidelines supported by the Health Resources and Services Administration. A health carrier may impose cost-sharing requirements for a treatment not described in this section even if the treatment results from an item or service described herein.

Del. Code tit. 18, § 3364 Specialty tier prescription coverage.

(a) Unless otherwise specifically provided, the definitions herein apply throughout this section. (1) “Class of drugs” means a group of medications having similar actions designed to treat a particular disease process. (2) “Coinsurance” means a cost-sharing amount set as a percentage of the total cost of the drug. (3) “Commissioner” means the Insurance Commissioner of this State. (4) “Copayment” means a cost-sharing amount set as a dollar value. (5) “Nonpreferred drug” means a specialty drug formulary classification for certain specialty drugs deemed nonpreferred and therefore subject to limits on eligibility for coverage or to higher cost-sharing amounts than preferred specialty drugs. (6) “Preferred drug” means a specialty drug formulary classification for certain specialty drugs deemed preferred and therefore not subject to limits on eligibility for coverage or not subject to higher cost-sharing amounts than nonpreferred specialty drugs. (7) “Specialty drug” means a prescription drug that: a. Is prescribed for a person with: 1. A complex or chronic medical condition, defined as a physical, behavioral, or developmental condition that may have no known cure and/or is progressive and/or can be debilitating or fatal if left untreated or under-treated, such as multiple sclerosis, hepatitis C, and rheumatoid arthritis; or 2. A rare medical condition, defined as any disease or condition that affects fewer than 200,000 persons in the United States, or about 1 in 1,500 people, such as cystic fibrosis, hemophilia, and multiple myeloma; and b. The total monthly cost of the prescription is $600 or more; and c. The drug is not stocked at a majority of retail pharmacies; and d. The drug has 1 or more of the following characteristics: 1. It is an oral, injectable, or infusible drug product. 2. It has unique storage or shipment requirements, such as refrigeration. 3. Patients receiving the drug require education and support beyond traditional dispensing activities. (8) “Specialty drug formulary” means a specialty drug benefit design that distinguishes for purposes of eligibility for coverage or for cost sharing between preferred drugs and nonpreferred drugs. (9) “Specialty drug tier” means a tier of cost sharing designed for specialty drugs that imposes a cost-sharing obligation for specialty drugs that exceeds the amount for nonspecialty drugs and such a cost-sharing amount is based on a coinsurance. (b) A health plan that provides coverage for prescription drugs and utilizes a specialty drug tier shall ensure that any required copayment or coinsurance applicable to specialty drugs on a specialty tier does not exceed $150 per month for each specialty drug up to a 30-day supply of any single drug. (c) A health plan that provides coverage for prescription drugs and utilizes a specialty drug formulary shall implement an exceptions process that allows enrollees to request an exception to the formulary. Under such an exception, a nonformulary specialty drug could be deemed covered under the formulary if the prescribing physician determines that the formulary drug for treatment of the same condition either would not be as effective for the individual, or would have adverse effects for the individual, or both. In the event an enrollee is denied an exception, such denial shall be considered an adverse event and will be subject to the health plan internal review process set forth in § 332 of this title and the state external review process set forth in § 6416 of this title. (d) A health plan that provides coverage for prescription drugs shall be prohibited from placing all drugs in a given class of drugs on a specialty tier. (e) Nothing in this section shall be construed to require a health plan to: (1) Provide coverage for any additional drugs not otherwise required by law; (2) Implement specific utilization management techniques, such as prior authorization or step therapy; or (3) Cease utilization of tiered cost-sharing structures, including those strategies used to incent use of preventive services, disease management, and low-cost treatment options. (f) Nothing in this section shall be construed to require a pharmacist to substitute a drug without the consent of the prescribing physician. (g) Nothing contained in any other provision of Delaware law or regulation shall preclude a health plan or other entity subject to this chapter from requiring specialty drugs to be obtained through a designated pharmacy or other source of such drugs.

Del. Code tit. 18, § 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) Except as provided by subsection (h) of this section, 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. (h) DPH shall have the authority to approve supervised clinical training rotations for mental health providers at SBHCs.

Del. Code tit. 18, § 3366 Autism spectrum disorders coverage.

(a) All individual health benefit plans as defined in § 3343(a) of this title shall provide coverage for the screening and diagnosis of autism spectrum disorders and the treatment of autism spectrum disorders in individuals less than 21 years of age. To the extent that the diagnosis of autism spectrum disorders and the treatment of autism spectrum disorders are not already covered by a health benefit plan, coverage under this section shall be included in health benefit plans that are delivered, issued, executed or renewed in this State pursuant to this title after December 11, 2012. No insurer shall terminate coverage or refuse to deliver, execute, issue, amend, adjust, or renew coverage to an individual solely because the individual or a family member is diagnosed with 1 of the autism spectrum disorders or has received treatment for autism spectrum disorders. Coverage under this section shall not be denied on the basis that the treatment is habilitative or nonrestorative in nature. (b) Coverage for applied behavior analysis services under this section by an insurer shall be subject to a maximum benefit of $36,000 per 12-month period per person, but shall not be subject to any limits on the number of visits an individual may make to an autism services provider or that a provider may make to an individual regardless of the locations in which services are provided. After December 31, 2012, the Insurance Commissioner shall, on or before April 1 of each calendar year, publish in the Delaware Register of Regulations an adjustment to the maximum benefit equal to the change in the United States Department of Labor Consumer Price Index for all Urban Consumers (CPI-U) in the preceding year and the published adjusted maximum benefit shall be applicable to all health insurance policies issued or renewed thereafter. Payments made by an insurer on behalf of a covered individual for treatment unrelated to applied behavior analysis shall not be applied toward any maximum benefit established under this subsection. (c) The coverage required under this section shall not be subject to dollar limits, deductibles, or coinsurance provisions that are less favorable to an insured than the dollar limits, deductibles, or coinsurance provisions that apply to physical illness generally under the health benefit plan, except as otherwise provided in subsection (b) of this section. (d) This section shall not be construed as limiting benefits that are otherwise available to an individual or family member under their health benefit plan. (e) As used in this section: (1) “Applied behavior analysis” means the design, implementation, and evaluation of environmental modifications, using behavioral stimuli and consequences, to produce socially significant improvement in human behavior, including the use of direct observation, measurement, and functional analysis of the relationship between environment and behavior. (2) “Autism services provider” means any person, entity, or group authorized by this section that provides treatment of autism spectrum disorders. This includes licensed physicians, psychologists or their assistants, psychiatrists, speech therapists or their aides, occupational therapists or their aides, physical therapists or their assistants, practitioners with the national certification of board-certified behavior analyst or those working under their supervision, licensed professional counselors of mental health, licensed clinical social workers, advanced practice nurses, or any person, entity, or group meeting the standards set by the Department of Health and Social Services as authorized by subsection (f) of this section. (3) “Autism spectrum disorders” means any of the pervasive developmental disorders as defined by the most recent edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM), including Autistic Disorder, Asperger’s Disorder and Pervasive Developmental Disorder Not Otherwise Specified, as such may be amended hereafter from time to time. (4) “Behavioral health treatment” means professional counseling, guidance services or treatment programs, including applied behavior analysis, that are necessary to develop, maintain, or restore, to the maximum extent practicable, the functioning of an individual. This definition also applies to treatment or counseling to improve social skills and function. (5) “Medically necessary” means reasonably expected to do the following: a. Prevent the onset of an illness, condition, injury, or disability; b. Reduce or ameliorate the physical, mental, or developmental effects of an illness, condition, injury, or disability; or c. Assist to achieve or maintain maximum functional capacity in performing daily activities, taking into account both the functional capacity of the individual and the functional capacities that are appropriate for individuals of the same age. (6) “Pharmacy care” means medications prescribed by a licensed practitioner and any health-related services deemed medically necessary to determine the need or effectiveness of the medications. (7) “Psychiatric care” means direct or consultative services provided by a psychiatrist licensed in the state in which the psychiatrist practices. (8) “Psychological care” means direct or consultative services provided by a psychologist licensed in the state in which the psychologist practices or by a psychological assistant acting under the supervision of a psychologist. (9) “Screening and diagnosis of autism spectrum disorders” means medically necessary assessments, evaluations, or tests to diagnose whether an individual has or is at risk for 1 of the autism spectrum disorders. (10) “Therapeutic care” means services provided by speech, occupational, or physical therapists or an aide or assistant under their supervision. (11) “Treatment for autism spectrum disorders” shall include the following care prescribed or ordered for an individual diagnosed with 1 of the autism spectrum disorders by a licensed physician or licensed psychologist who determines the care to be medically necessary: a. Behavioral health treatment; b. Pharmacy care; c. Psychiatric care; d. Psychological care; e. Therapeutic care; f. Items and equipment necessary to provide, receive, or advance in the above-listed services, including those necessary for applied behavioral analysis; and g. Any care for individuals with autism spectrum disorders that is determined by the Secretary of the Department of Health and Social Services, based upon their review of best practices and/or evidence-based research, to be medically necessary. The Secretary shall inform the Insurance Commissioner of such determination, and upon receiving notice the Insurance Commissioner shall issue a bulletin stating that any such care, treatment, intervention, service, or item that was not previously covered shall be included in any health benefit plan delivered, executed, issued, amended, adjusted, or renewed on or after 120 days following the date of such bulletin. (f) The Department of Health and Social Services shall promulgate regulations establishing standards for certifying qualified autism services providers by June 11, 2013, If an autism services provider meets recognized national certification as a board-certified behavior analyst, such autism services provider shall be deemed to have met the standards to be established under this section, to provide applied behavioral analysis services. Once the regulations are promulgated, payment for the treatment of autism spectrum disorders covered under this section shall only be required to be made to autism services providers who meet the standards. (g) Except for inpatient services, if an individual is receiving treatment for autism spectrum disorders, an insurer will have the right to request a review of that treatment not more than once every 12 months unless the insurer and the licensed physician or licensed psychologist agree that a more frequent review is necessary. The cost of obtaining any review shall be borne by the insurer. (h) This section shall not be construed as affecting any obligation to provide services to an individual under an individualized family service plan (IFSP); an individualized education program (IEP); an individual plan for employment (IPE); a 504 plan; or an individualized service plan, including an essential lifestyle plan (ELP). (i) The Insurance Commissioner may promulgate rules and regulations as may be necessary or appropriate to implement and administer this section, except for subsection (f) of this section.

Del. Code tit. 18, § 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.

Del. Code tit. 18, § 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, 2025; 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.

Del. Code tit. 18, § 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.

Del. Code tit. 18, § 3370 Telehealth and telemedicine.

(a) For purposes of this section: (1) “Distant site” means a site at which a health-care provider legally allowed to practice in Delaware is located while providing health-care services by means of telemedicine or telehealth. (2) “Originating site” means a site in Delaware at which a patient is located at the time health-care services are provided to the patient by means of telemedicine or telehealth, unless the term is otherwise defined with respect to the provision in which it is used. Notwithstanding any other provision of law, insurers and providers may agree to alternative siting arrangements deemed appropriate by the parties. (3) “Store and forward transfer” means the transmission of a patient’s medical information either to or from an originating site or to or from the provider at the distant site, but does not require the patient being present nor must it be in real time. (4) “Telehealth” means the use of information and communications technologies consisting of telephones, remote patient monitoring devices or other electronic means which support clinical health-care provider consultation, patient and professional health-related education, public health, health administration, and other services as authorized in Chapter 60 of Title 24. (5) “Telemedicine” is a subset of telehealth which is the delivery of clinical health-care services and other services, as authorized in Chapter 60 of Title 24, by means of real time 2-way audio, visual, or other telecommunications or electronic communications, including the application of secure video conferencing or store and forward transfer technology to provide or support health-care delivery, which facilitate the assessment, diagnosis, consultation, treatment, education, care management and self-management of a patient’s health care by a health-care provider legally allowed to practice in Delaware and practicing within the health-care provider’s scope of practice as would be practiced in-person with a patient, while such patient is at an originating site and the health-care provider is at a distant site. (b) Each insurer proposing to issue individual or group accident and sickness insurance policies providing hospital, medical and surgical, or major medical coverage on an expense-incurred basis; each health service corporation providing individual or group accident and sickness subscription contracts; and each health maintenance organization providing a health-care plan for health-care services shall provide coverage for the cost of such health-care services provided through telemedicine. (c) Each insurer proposing to issue individual or group accident and sickness insurance policies providing hospital, medical and surgical, or major medical coverage on an expense-incurred basis; each health service corporation providing individual or group accident and sickness subscription contracts; and each health maintenance organization providing a health-care plan for health-care services shall provide coverage for the cost of such health-care services provided through telehealth as directed through regulations promulgated by the Department. (d) An insurer, health service corporation, or health maintenance organization shall not exclude a service for coverage solely because the service is provided through telemedicine services and is not provided through in-person consultation or contact between a health-care provider and a patient for services appropriately provided through telemedicine services. (e) An insurer, health service corporation, or health maintenance organization shall reimburse the treating provider or the consulting provider for the diagnosis, consultation, or treatment of the insured delivered through telemedicine services on the same basis and at least at the rate that the insurer, health service corporation, or health maintenance organization is responsible for coverage for the provision of the same service through in-person consultation or contact. Payment for telemedicine interactions shall include reasonable compensation to the originating or distant site for the transmission cost incurred during the delivery of health-care services. (f) No insurer, health service corporation, or health maintenance organization shall impose any annual or lifetime dollar maximum on coverage for telemedicine services other than an annual or lifetime dollar maximum that applies in the aggregate to all items and services covered under the policy, or impose upon any person receiving benefits pursuant to this section any copayment, coinsurance, or deductible amounts, or any policy year, calendar year, lifetime, or other durational benefit limitation or maximum for benefits or services, that is not equally imposed upon all terms and services covered under the policy, contract, or plan. (g) The requirements of this section shall apply to all insurance policies, contracts, and plans delivered, issued for delivery, reissued, or extended on and after January 1, 2016, or at any time thereafter when any term of the policy, contract, or plan is changed or any premium adjustment is made. (h) This section shall not apply to short-term travel, accident-only, limited or specified disease, or individual conversion policies or contracts, nor shall it contravene any telehealth requirements made in 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.

Del. Code tit. 18, § 3370A Network disclosure and transparency.

(a) This section applies to every policy or contract of health insurance which is delivered or issued for delivery in this State, including each policy or contract issued by a health-service corporation, which provides medical, major medical, or similar comprehensive-type coverage, and which designates network physicians or providers (hereinafter referred to collectively as “network providers”). However, this section applies only to items, services or conditions for which coverage is provided by those policies or contracts (hereinafter referred to as “covered services”). (b) For purposes of this section “facility-based provider” means a provider who provides health-care services to covered persons who are in an in-patient or ambulatory facility, including services such as pathology, anesthesiology, or radiology. (c) For purposes of this section “health-care provider” means any provider who provides health-care services to covered persons who are not in a facility-based setting, and includes a provider who provides health-care services to a covered person based upon a referral from another provider without the knowledge of or input from the covered person. (d) Nonemergency out-of-network services. — (1) When a facility-based provider schedules a procedure, seeks prior authorization from a health carrier for the provision of nonemergency covered services to a covered person or prior to the provision of any nonemergency covered services, the facility shall ensure that the covered person has received a timely written out-of-network disclosure that states the following: a. That discloses whether the facility is a participating or out-of-network facility; b. That certain facility-based providers may be called upon to render care to the covered person during the course of treatment; c. That those facility-based providers may not have a contract with the covered person’s health insurer and are therefore considered to be out-of-network; d. That the services therefore will be provided on an out-of-network basis, which may result in additional charges for which the covered person may be responsible, and a statement that these charges are in addition to any coinsurance, deductibles and copayments applicable under the covered person’s health insurance policy; e. A listing, including name and contact information, of those facility-based providers who may be called upon to render care to the covered person during the course of treatment, and a statement that the covered person should contact their health insurer to determine the network status of those facility-based providers; f. Notification that an estimate of the range of charges charged by the out-of-network provider for any out-of-networks services for which the covered person may be responsible may be requested from, and will be timely provided by, the out-of-network provider; and g. That the covered person may contact the covered person’s health insurer for additional assistance or may rely on whatever other rights and remedies may be available under state or federal law. h. The written out-of-network disclosure required by this paragraph (d)(1) shall include a written consent form which would enable a covered person who wishes to utilize the services of an out-of-network provider to: (i) acknowledge a provider may be a non-network provider; (ii) acknowledge that the services provided by the non-network provider may not be covered by the covered person’s policy; (iii) acknowledge receipt of the notification that an estimate of the range of charges for any out-of-network services for which the covered person may be responsible may be obtained from the out-of-network providers; and (iv) affirmatively elect to obtain the services and agree to accept and pay the charges for the out-of-network services. i. If a covered person requests from an out-of-network provider an estimate of the range of charges for any out-of-network services for which the covered person may be responsible, the out-of-network provider shall provide the estimate in writing to the covered person within 3 business days of the request. j. If the facility and all facility-based providers participate in the covered person’s network, this disclosure shall not be required. (2) Prior to the delivery of nonemergency covered services to a covered person, an out-of-network health-care provider shall provide the covered person with a timely, written out-of-network disclosure that states the following: a. That the health-care provider is an out-of-network provider and the services therefore will be provided on an out-of-network basis; b. That out-of-network services may result in additional charges for which the covered person may be responsible, and a statement that these charges are in addition to any coinsurance, deductibles and copayments applicable under the person’s health insurance policy; c. Identification of the range of charges charged by the out-of-network health-care provider for any out-of-network services for which the covered person may be responsible; and d. That the covered person may contact the covered person’s health insurer for additional assistance or may rely on whatever other rights and remedies may be available under state or federal law. e. The written out-of-network disclosure required by this paragraph (d)(2) shall contain a written consent form which would enable a covered person who wishes to utilize the services of an out-of-network provider to: (i) acknowledge a provider may be a non-network provider; (ii) acknowledge that the services provided by the non-network provider may not be covered by the insured’s policy; (iii) acknowledge receipt of the identification of the range of charges for any out-of-network services for which the covered person may be responsible; and (iv) affirmatively elect to obtain the services and agree to accept and pay the charges for the out-of-network services. (3) A facility-based provider or a health-care provider may not balance bill a covered person for health-care services not covered by an insured’s health insurance contract, if the facility-based provider or health-care provider: a. Fails to provide to the covered person the written out-of-network disclosure required by paragraphs (d)(1) or (2) of this section. b. Fails to obtain from the covered person in a timely manner, before the health-care services are provided, a copy of the consent form required by paragraphs (d)(1) or (2) of this section that has been signed by the covered person. (4) Nothing in paragraph (d)(3) of this section shall prevent the operation of policy provisions involving coinsurance, deductibles and copayments payable under the insured health insurance policy. (5) In the event a facility-based provider or a health-care provider fails to comply with the requirements of paragraphs (d)(3)a. or (3)b. of this section, and the provider of services and insurer cannot agree on the appropriate rate of reimbursement, the provider shall be entitled to those charges and rates allowed by the Insurance Commissioner or the Commissioner’s designee following arbitration of the dispute pursuant to the procedures set forth in § 333 of this title and any regulation promulgated thereunder. (6) This section shall not apply to those out-of-network services provided pursuant to §§ 3348 and 3349 of this title. (e) Health insurers shall be required to maintain accurate and complete provider directories, to update provider directories frequently, to audit the accuracy and completeness of such directories and make the directories easily accessible to the covered person in a variety of formats. (f) The Insurance Commissioner shall adopt regulations to implement the requirements of this section, including: (1) Regulations concerning the form and content of the written out-of-network disclosures and written consent form required by paragraphs (d)(1) and (2) of this section. (2) Regulations requiring health insurers and out-of-network providers to inform covered persons of their rights with respect to payment of balance bills. (3) Regulations concerning the provisions of subsection (e) of this section. — The regulations adopted and arbitrations authorized pursuant to this section shall reflect the objectives of protecting consumers from surprise bills and not creating incentives for providers to be out-of-network.

Del. Code tit. 18, § 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.

Del. Code tit. 18, § 3370C Time of submitting claim for reimbursement.

Del. Code tit. 18, § 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.

Del. Code tit. 18, § 3370E Annual behavioral health well check.

(a) As used in this section: (1) “Behavioral health well check” means a predeductible annual visit with a licensed mental health clinician with at minimum a masters level degree. The well check must include but is not limited to a review of medical history, evaluation of adverse childhood experiences, use of a group of developmentally-appropriate mental health screening tools, and may include anticipatory behavioral health guidance congruent with stage of life using the diagnosis of “annual behavioral health well check.” (2) “Carrier” means any entity that provides health insurance in this State that is subject to the provisions of this chapter. “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. (b) All carriers shall provide coverage of an annual behavioral health well check, which, except as provided in subsection (d) of this section, shall be reimbursed through the following common procedural terminology (CPT) codes at the same rate that such CPT codes are reimbursed for the provision of other medical care, provided that reimbursement may be adjusted for payment of claims that are billed by a nonphysician clinician so long as the methodology to determine such adjustments is comparable to and applied no more stringently than the methodology for adjustments made for reimbursement of claims billed by nonphysician clinicians for other medical care, in accordance with 45 CFR § 146.136(c)(4): (1) 99381. (2) 99382. (3) 99383. (4) 99384. (5) 99385. (6) 99386. (7) 99387. (8) 99391. (9) 99392. (10) 99393. (11) 99394. (12) 99395. (13) 99396. (14) 99397. (c) (1) The Commissioner shall update this list of codes through the promulgation of rules if the CPT codes listed in subsection (b) of this section are altered, amended, changed, deleted, or supplemented. (2) Reimbursement of any of the CPT codes listed in subsection (b) of this section or promulgated under paragraph (c)(1) of this section for the purpose of covering an annual behavioral health well check may not be denied because such CPT code was already reimbursed for the purpose of covering a service other than an annual behavioral health well check. (3) Reimbursement of any of the CPT codes listed in subsection (b) of this section or promulgated under paragraph (c)(1) of this section for the purpose of covering a service other than an annual behavioral health well check may not be denied because such CPT code was already reimbursed for the purpose of covering an annual behavioral health well check. (d) An annual behavioral health well check may be reimbursed through a value-based arrangement, a capitated arrangement, a bundled payment arrangement, or any other alternative payment arrangement that is not a traditional fee-for-service arrangement, provided that a carrier must have documentation demonstrating that within such payment arrangement the annual behavioral health well check is valued commensurate to the value established under subsection (b) of this section. (e) An annual behavioral health well check may be incorporated into and reimbursed within any type of integrated primary care service delivery method including, but not limited to, the psychiatric collaborative care model, the primary care behavioral health model or behavioral health consultant model, any model that involves co-location of mental health professionals within general medical settings, or any other integrated care model that focuses on the delivery of primary care. (f) Nothing in this section prevents the operation of policy provisions such as copayments, coinsurance, allowable charge limitations, coordination of benefits, or provisions restricting coverage to services rendered by licensed, certified, or carrier-approved providers or facilities.

Del. Code tit. 18, § 3370F Supplemental and diagnostic breast examinations [For application of this section, see 84 Del. Laws, c. 121, § 5].

(a) As used in this section: (1) “Breast magnetic resonance imaging” or “breast MRI” means a diagnostic tool, including standard and abbreviated breast MRI, that uses radio waves and magnets to produce detailed images of structures within the breast. A breast MRI may be used as a screening tool when clinically indicated, including after indeterminant results from a mammogram that requires additional evaluation and for those at high risk for breast cancer. (2) “Breast ultrasound” means a noninvasive diagnostic tool that uses high-frequency sound waves and their echoes to produce detailed images of structures within the breast. A breast ultrasound may be used as a screening tool when clinically indicated, including after indeterminant results from a mammogram that requires additional evaluation and for those at high risk for breast cancer. (3) “Cost-sharing requirement” means a deductible, coinsurance, or copayment and any maximum limitation on the application of such a deductible, coinsurance, copayment, or similar out-of-pocket expense. (4) “Diagnostic breast examination” means a medically-necessary and clinically-appropriate examination of the breast, including such examination using breast MRI, breast ultrasound, or mammogram, that is used for either of the following: a. To evaluate an abnormality seen or suspected from a screening examination for breast cancer. b. To evaluate an abnormality detected by another means of examination. (5) “Mammogram” means a diagnostic or screening mammography exam using a low-dose X-ray to produce an image of the breast. (6) “Supplemental breast screening examination” means a medically-necessary and clinically-appropriate examination of the breast, including such examination using breast MRI, breast ultrasound, or mammogram, that is used for either of the following: a. To screen for breast cancer when there is no abnormality seen or suspected in the breast. b. Based on personal or family medical history or additional factors that may increase the individual’s risk of breast cancer. (b) All individual health insurance policies, contracts, or certificates that are delivered, issued for delivery, extended, or modified in this State shall provide coverage for diagnostic breast examinations and supplemental breast screening examinations. The terms of such coverage, including cost-sharing requirements, shall be no less favorable than the cost-sharing requirements applicable to screening mammography for breast cancer. (c) This section does not apply to any of the following: (1) A high deductible health plan if providing coverage under subsection (b) of this section would cause the plan to fail to be treated as a high deductible health plan under § 223(c)(2) of the Internal Revenue Code [26 U.S.C. § 223(c)(2)]. (2) A catastrophic health plan if providing coverage under subsection (b) of this section would cause the plan to fail to be treated as a catastrophic plan under § 1302(e) of the Patient Protection and Affordable Care Act, 42 U.S.C. § 18022(e). (3) A specified accident, specified disease, hospital indemnity, Medicare supplement, long-term care or other limited benefit health insurance policy. (d) If, at any time, the State is required under federal law to defray the cost of any coverage required under this section, the requirements under this section are inoperative and the State does not assume any obligation for the cost of coverage.

Del. Code tit. 18, § 3370G Coverage for allergenic protein dietary supplements [For application of this section, see 84 Del. Laws, c. 376, § 5].

(a) For purposes of this section: (1) “Dietary supplement” means as defined in the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321. (2) “Early egg allergen introduction dietary supplement” means a dietary supplement that is prescribed to an infant by a health-care practitioner and contains sufficient infant-safe, well-cooked egg protein to reduce the risk of food allergies. (3) “Early peanut allergen introduction dietary supplement” means a dietary supplement that is prescribed to an infant by a health-care practitioner and contains sufficient infant-safe peanut protein to reduce the risk of food allergies. (4) “Health-care practitioner” means an individual licensed and authorized to write medical orders for an individual under Title 24. (5) “Infant” means a child who has not attained the age of 1 year. (b) (1) 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 at least 1 of each of the following: a. An early egg allergen introduction dietary supplement. b. An early peanut allergen introduction dietary supplement. (2) The coverage required under paragraph (b)(1) of this section shall be provided at no cost to a covered individual, including deductible payments and cost-sharing amounts charged once a deductible is met. (c) Except as provided under subsection (b) of this section, 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) 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. (2) The cost-sharing limitation under paragraph (b)(2) of this section does not apply to a catastrophic health plan to the extent this cost-sharing limitation would cause the plan to fail to be treated as a catastrophic plan under § 1302(e) of the Patient Protection and Affordable Care Act, 42 U.S.C. § 18022(e). (3) a. The cost-sharing limitation under paragraph (b)(2) of this section does not apply to a high deductible health plan to the extent this cost-sharing limitation would cause the plan to fail to be treated as a high deductible health plan under § 223(c)(2) of the Internal Revenue Code [26 U.S.C. § 223(c)(2)]. b. If the cost-sharing limitation under paragraph (b)(2) of this section would result in an enrollee becoming ineligible for a health savings account under federal law, this cost-sharing limitation only applies to a qualified high deductible health plan after the enrollee’s deductible has been met.

Del. Code tit. 18, § 3370H Services related to termination of pregnancy.

(a) As used in this section: (1) “Carrier” means any entity that provides health insurance in this State that is subject to the provisions of this chapter. “Carrier” includes an insurance company, health service corporation, managed care organization, 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) “Health benefit plan” means as defined in § 3342A of this title. (b) A carrier shall cover services related to the termination of pregnancy for enrollees. (1) a. Except as provided in paragraphs (b)(1)b. and (b)(1)c. of this section, coverage provided under this section may not be subject to any deductible, coinsurance, copayment, or any other cost-sharing requirement. b. The limitations on cost-sharing in paragraph (b)(1)a. of this section do not apply to a high deductible health plan or a catastrophic health plan if the limitations would cause such plan to lose its status as a high deductible health plan under § 223(c)(2) of the Internal Revenue Code [26 U.S.C. § 223(c)(2)] or a catastrophic health plan under § 1302(e) of the Patient Protection and Affordable Care Act, 42 U.S.C. § 18022(e). c. Coverage under this section may be limited to $750 per covered individual per year. (2) A carrier must provide coverage for the full scope of services permissible under the law. (3) Coverage provided under this section may not require a referral or prior authorization as a condition of coverage. (4) If a policy or contract limits an insured’s access to a network of participating providers for other health-care services, then it may limit access for services related to termination of pregnancy, but the policy or contract must include in all its provider networks sufficient numbers of providers of termination of pregnancy services to accommodate the direct access needs of their enrollees. (c) This section applies to all policies, contracts, or certificates issued, renewed, modified, altered, amended, or reissued after December 31, 2025.

Del. Code tit. 18, § 3370I Coverage for doula services.

(a) “Doula services” means services provided by a trained doula and designed to provide physical, emotional, and educational support to pregnant and birthing persons, before, during, and after childbirth. “Doula services” include the following: (1) Support and assistance during labor and childbirth. (2) Prenatal and postpartum support and education. (3) Breastfeeding assistance and lactation support. (4) Parenting education. (5) Support for a birthing person following loss of pregnancy. (b) All individual health insurance policies, contracts, or certificates that are delivered, issued for delivery, renewed, extended, or modified in this State after December 31, 2025, shall provide coverage for doula services, when provided by a doula who is certified by the Delaware Certification Board, that includes all of the following: (1) Three prenatal visits of up to 90 minutes. (2) Three postpartum visits of up to 90 minutes. (3) Attendance through labor and birth. (c) Coverage must be provided for additional postpartum doula visits with a recommendation from a practitioner or clinician licensed under Title 24 acting within their scope of practice. (d) (1) Nothing in this section prevents the operation of policy provisions such as deductibles, coinsurance, allowable charge limitations, or coordination of benefits. (2) Carriers may require doulas to be certified or registered in the same manner required by the Division of Medicaid and Medical Assistance under § 530 of Title 31. (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.

Del. Code tit. 18, § 3370J Pharmacist services reimbursement [For application of this section, see 85 Del. Laws, c. 253, § 23].

(a) For purposes of this section, “carrier” means any entity that provides health insurance in this State. “Carrier” includes any insurance company, managed care organization, 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. (b) For any individual insurance policy, contract, or certificate that is delivered, issued for delivery, renewed, extended, or modified in this State after January 1, 2025, a carrier must provide reimbursement to a pharmacist for a service or procedure at a rate not less than that provided to other nonphysician practitioners if the service or procedure is all of the following: (1) Within the scope of practice of a pharmacist. (2) Would otherwise be covered under the policy, plan, or contract if the service or procedure is provided by any health-care service provider or practitioner, including a physician, advance practice registered nurse, or physician associate. (c) Whenever a service is performed by a licensed pharmacist and reimbursed by a carrier, the licensed pharmacist must be granted such rights of participation, plan admission, and registration as may be granted by the carrier to any health-care service provider or practitioner, including a physician, advance practice registered nurse, or physician associate performing such a service.

Del. Code tit. 18, § 3370K Annual mammograms.

(a) As used in this section, “Carrier” means any entity that provides health insurance in this State that is subject to the provisions of this chapter. “Carrier” includes an insurance company, health service corporation, health maintenance organization, managed care 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. (b) All carriers shall provide coverage for annual mammograms for the purpose of early detection for a woman 40 years of age or older, with or without referral from the woman’s health-care provider. (c) This section does not apply to accident-only, specified disease, hospital indemnity, Medicare supplement, long-term disability income, or other limited benefit health insurance policies.

Del. Code tit. 18, § 3370L Developmentally-delayed speech coverage [For application of this section, see 84 Del. Laws, c. 520, § 3].

(a) For the purpose of this section “child” means a child from birth to age 18. (b) Every individual health insurance contract, including each policy or contract delivered, issued for delivery, or renewed in this State after December 31, 2024, shall provide coverage for any therapy or services required to treat a child diagnosed with any of the following speech-language disorders classified in the International Classification of Diseases (ICD-10): (1) Childhood onset fluency disorder. (2) Developmental disorder of speech and language unspecified. (3) Expressive language disorder. (4) Mixed receptive-expressive language disorder. (5) Phonological disorder. (6) Receptive language disorder. (7) Social pragmatic communication disorder. (c) This section does not apply to insurance coverage providing benefits exclusively for: (1) Hospital confinement indemnity. (2) Disability income. (3) Accident only. (4) Long-term care. (5) Medicare supplement. (6) Limited benefit health. (7) Specified disease indemnity. (8) Sickness or bodily injury or death by accident; or both. (d) 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.

Del. Code tit. 18, § 3370M Coverage for removal of excess skin and subcutaneous tissue [For application of this section, see 85 Del. Laws, c. 88, § 5].

(a) For purposes of this section: (1) “Medically necessary” means as defined in § 3371 of this title. (2) “Panniculectomy” means an operative procedure used to contour the abdominal wall by removing significant excess skin and subcutaneous adipose tissue. (b) All individual health insurance policies, contracts, or certificates that are delivered, issued for delivery, renewed, extended, or modified in this State must provide coverage for medically necessary removal of excess skin and subcutaneous tissue, including a panniculectomy. (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) 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.

Del. Code tit. 18, § 3370N Coverage for pre-exposure prophylaxis treatment and post-exposure prophylaxis treatment [For application of this section, see 85 Del. Laws, c. 452, § 5].

(a) As used in this section: (1) “Cost-sharing requirement” includes a deductible, coinsurance, copayment, and out-of-pocket expense. (2) “Essential support services” include all of the following: a. HIV testing. b. Hepatitis B and C testing. c. Kidney function assessment through creatinine testing and calculated estimated creatinine clearance or glomerular filtration rate. d. Pregnancy testing. e. Sexually transmitted infection screening and counseling. f. Adherence counseling. (3) “FDA” means the United States Food and Drug Administration. (4) “HIV” means the human immunodeficiency virus. (5) “Medically necessary” means as defined in § 3371 of this title. (6) “PEP” means post-exposure prophylaxis medication for preventing HIV infection after possible HIV exposure. (7) “PrEP” means pre-exposure prophylaxis medication for preventing HIV infection before possible HIV exposure. (8) “Therapeutic equivalent” means a PrEP or a PEP that is all of the following: a. Approved as safe and effective. b. Pharmaceutically equivalent to another PrEP or another PEP because it contains an identical amount of the same active drug ingredient in the same dosage form and route of administration and meets compendial or other applicable standards of strength, quality, purity, and identity. c. Assigned, by the FDA, the same therapeutic equivalence code as another PrEP or another PEP. (b) (1) All individual health insurance policies, contracts, or certificates that are delivered, issued for delivery, renewed, extended, or modified in this State must provide coverage for all of the following: a. Medically necessary PrEP. b. Medically necessary PEP. c. Medically necessary essential support services. (2) Except as otherwise provided in paragraph (b)(3) of this section, the coverage required under paragraph (b)(1) of this section must be provided without any of the following: a. Cost-sharing requirements. b. Prior authorization or step therapy requirements. c. Unreasonable delay in coverage determination. (3) a. If the FDA has approved 1 or more therapeutic equivalents of a PrEP or a PEP, a health benefit plan is not required to cover all of the therapeutic equivalent versions of that PrEP or that PEP, so long as at least 1 therapeutic equivalent version of that PrEP and at least 1 therapeutic equivalent version of that PEP are covered without cost-sharing, prior authorization, or step therapy requirements. For purposes of this section, a long-acting version of a PrEP or a PEP is not therapeutically equivalent to another long-acting version of a PrEP or a PEP with a different duration. b. If there is a therapeutic equivalent of a PrEP or a PEP, a health benefit plan may provide coverage for more than 1 version of that PrEP or that PEP and may impose cost-sharing, prior authorization, or step therapy requirements, so long as at least 1 version of that PrEP and at least 1 version of that PEP in the same method of administration is covered without cost-sharing, prior authorization, or step therapy requirements. But a health benefit plan must provide coverage for a particular PrEP or a particular PEP without cost-sharing, prior authorization, or step therapy requirements, regardless of whether the PrEP or the PEP has a therapeutic equivalent, if a covered individual’s treating health-care provider recommends that particular PrEP or that particular PEP based on a medical determination regarding that covered individual. (c) Except as otherwise provided in subsection (b) of this section, 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) This section does not apply to accident-only, specified disease, hospital indemnity, Medicare supplement, long-term care, disability income, or other limited health insurance policies. (2) The cost-sharing limitation under paragraph (b)(2) of this section does not apply to a catastrophic health plan to the extent this cost-sharing limitation would cause the plan to fail to be treated as a catastrophic health plan under § 1302(e) of the Patient Protection and Affordable Care Act, 42 U.S.C. § 18022(e). (3) a. The cost-sharing limitation under paragraph (b)(2) of this section does not apply to a high deductible health plan to the extent this cost-sharing limitation would cause the plan to fail to be treated as a high deductible health plan under § 223(c)(2) of the Internal Revenue Code [26 U.S.C. § 223(c)(2)]. b. If the cost-sharing limitation under paragraph (b)(2) of this section would result in an enrollee becoming ineligible for a health savings account under federal law, the cost-sharing limitation only applies to a qualified high deductible plan after the enrollee’s deductible has been met.

Del. Code tit. 18, § 3370O Coverage for diagnostic services and treatment for menopause and perimenopause [For application of this section, see 85 Del. Laws, c. 482, § 5].

(a) As used in this section: (1) “Hormone replacement therapy” means medical treatment, approved by the United States Food and Drug Administration, that replaces a hormone that an individual’s body is no longer making or no longer making enough of, as determined by a licensed health-care professional. “Hormone replacement therapy” includes prescribing any of the following: a. A cream. b. An oral medication. c. A vaginal device. d. Another method approved by the United States Food and Drug Administration. (2) “Medically necessary” means providing of health-care services or products that a prudent licensed health-care professional 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. d. Not including investigational or experimental health-care services. (3) “Menopause” means the permanent end of menstruation due to loss of ovarian follicular function, characterized by the end of ovulation and a decline in estrogen and progesterone production. (4) “Menopause and perimenopause symptoms” include any of the following: a. Irregular menstrual periods. b. Hot flashes. c. Vaginal or bladder changes, including genitourinary syndrome of menopause. d. Decreased fertility. e. Loss of bone density, including osteoporosis. f. Elevated low-density lipoprotein cholesterol levels. g. Sleep disturbances, including night sweats. (5) “Perimenopause” means the transitional period leading to menopause, marked by fluctuating hormone levels and changes in the menstrual cycle. (b) (1) All individual health insurance policies, contracts, or certificates that are delivered, issued for delivery, renewed, extended, or modified in this State must provide coverage for medically necessary diagnostic services and treatment for menopause, perimenopause, and menopause and perimenopause symptoms, including all of the following: a. Consultation and diagnostic testing. b. Hormonal therapies, including hormone replacement therapy and bioidentical hormone treatments, that are approved by the United States Food and Drug Administration. c. Nonhormonal treatments, including selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, neurokinin B antagonists, and other medications to manage menopause and perimenopause symptoms. d. All drugs, devices, and combination products approved by the United States Food and Drug Administration for the treatment of menopause and perimenopause symptoms. e. Therapy to treat menopause induced by a hysterectomy. f. Behavioral health care services. g. Pelvic floor physical therapy. h. Bone health treatments due to hormonal changes related to menopause and perimenopause, including screenings and medications. i. Preventative services for early detection and treatment of health conditions related to menopause and perimenopause, including osteoporosis and cancer. j. Counseling and education regarding menopause management. (2) An insurer shall provide clear and accessible information to each covered individual regarding covered diagnostic services and treatment for menopause, perimenopause, and menopause and perimenopause symptoms. (3) Coverage for medically necessary hormone replacement therapy provided under this section may not be any of the following: a. Denied or limited, if the use of the hormone replacement therapy is supported by national clinical guidelines, national standards of care, or peer-reviewed medical literature for the treatment of menopause, perimenopause, or menopause and perimenopause symptoms. b. Subject to prior authorization or step therapy requirements. (4) Except as otherwise provided in paragraph (b)(3) of this section, benefits provided under this section must be provided to covered individuals to the same extent as other benefits for any other medical condition covered under the individual health insurance policy, contract, or certificate. (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) This section does not apply to accident-only, specified disease, hospital indemnity, Medicare supplement, long- term care, disability income, or other limited health insurance policies.

Del. Code tit. 18, § 3370P Biomarker testing [For application of this section, see 85 Del. Laws, c. 484, § 5].

(a) For purposes of this section: (1) “Biomarker” means a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a specific therapeutic intervention, including known gene-drug interactions for medications being considered for use or already being administered. Biomarkers include gene mutations, characteristics of genes, and protein expression. A biomarker is not an assessment of how a covered person or enrollee feels, functions or survives. (2) “Biomarker testing” means the analysis of an individual’s tissue, blood, or other biospecimen for the presence of a biomarker. Biomarker testing includes single-analyte tests, multi-plex panel tests, protein expression, and whole exome, whole genome, and whole transcriptome sequencing. (3) “Investigatory and experimental biomarker tests” means biomarker tests that are subject to the United States food and drug administration’s investigational device exemption (C.F.R. Part 812). (4) “Medically necessary” means as defined in § 3371 of this title. (5) “Nationally recognized clinical practice guideline” means an evidence-based clinical practice guideline developed by independent organizations or medical professional societies using a transparent methodology and reporting structure and with a conflict-of-interest policy. A clinical practice guideline establishes a standard of care informed by a systematic review of evidence and an assessment of the benefits and risks of alternative care options and includes recommendations intended to optimize patient care. (6) “Screening” means a medical procedure or test for a covered person who has yet to display symptoms of a particular disease or condition for the purpose of determining the person’s likelihood of having the disease or condition. (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 biomarker testing to guide or inform treatment decisions for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a covered person’s disease or condition when the test is medically necessary as demonstrated by medical and scientific evidence, including any of the following: (1) Labeled indications for an FDA-approved or FDA-cleared test. (2) Indicated tests for an FDA-approved drug. (3) Warnings and precautions on FDA-approved drug labels. (4) Centers for Medicare and Medicaid Services (CMS) national coverage determinations or Medicare administrative contractor (MAC) local coverage determinations. (5) Nationally recognized clinical practice guidelines. (c) A biomarker test that meets 1 of the medical and scientific evidence outlined in paragraphs (b)(1) through (b)(5) of this section shall not be considered an investigational or experimental health-care service. (d) Insurers, health-benefit plans, and health-service corporations must ensure that coverage for biomarker testing, as required by subsection (b) of this section, is provided in a manner that limits disruptions in care, including the need for multiple biopsies or biospecimen samples. (e) 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. (f) Nothing in this section restricts the use of utilization management. (g) Nothing in this section shall be construed to require coverage of biomarker testing for screening purposes or coverage of investigatory and experimental biomarker tests. (h) 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.

Del. Code tit. 18, § 3371 Definitions [For application of this section, see 82 Del. Laws, c. 44, § 3; 85 Del. Laws, c. 176, § 4].

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) “Episode of care” means care that meets all of the following: a. Is for a specific medical problem, condition, or illness being managed by a health-care provider, including tests, procedures, and rehabilitation initially requested by the health-care provider. b. Is performed at the site of service. c. Is not out-of-network care. (8) “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. (9) “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. (10) “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. (11) “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. (12) “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. (13) “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. (14) “Urgent health-care service” means a covered health-care service subject to prior authorization that is delivered on an expedited basis for the treatment of an acute condition with symptoms of sufficient severity pursuant to a determination by a licensed treating health-care provider, operating within the health-care provider’s scope of practice and professional expertise, that the failure to provide the service is likely to result in serious, long-term health complications or a material deterioration in the covered person’s or enrollee’s condition and prognosis. (15) “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.

Del. Code tit. 18, § 3372 Disclosure and review of pre-authorization requirements; adverse determinations [For application of this section, see 85 Del. Laws, c. 176, § 4].

(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) (1) If an insurer, health-benefit plan, health-service corporation, or utilization review entity intends either to implement a new pre-authorization requirement or restriction, 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 care service and all contracted health-care providers who provide the 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. (2) Notwithstanding the provisions of paragraph (c)(1) of this section, if an insurer, health-benefit plan, health-service corporation, or utilization review entity changes utilization review terms, such as clinical criteria, for a health-care service, the change in utilization review terms does not apply to covered persons with an existing authorization for the health-care service, and will apply only upon re-authorization of the health-care service. An insurer, health-benefit plan, health-service corporation, or utilization review entity must provide notice to covered persons at least 6 months before any changes to utilization review terms for a health-care service, unless those changes were due to clinical guideline status changes, recalls, market withdrawals or relevant FDA published safety information. (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 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. e. Number of denials overturned upon appeal. (e) Utilization review; specific requirements related to adverse determinations. — (1) When a clean pre-authorization request is submitted by a physician or representative of a physician, an insurer, health-benefit plan, health-service corporation, or utilization review entity must ensure that any adverse determination is made by a physician who meets all of the following requirements: a. Any compensation paid to the physician is not contingent upon the outcome of the review. b. At least 1 of the following requirements is satisfied: 1. The physician is licensed in any United States jurisdiction with appropriate training, knowledge, or experience in the same or similar specialty that typically manages or consults on the health-care service in question. 2. The physician is licensed in any United States jurisdiction, in consultation with an appropriately qualified third-party health-care provider licensed in the same or similar medical specialty as the requesting physician, or a health-care provider with experience related to the covered person’s associated condition. Any compensation paid to the consulting health-care provider may not be contingent upon the outcome of the review. (2) An insurer, health-benefit plan, health-service corporation, or utilization review entity must ensure that all appeals of an adverse determination related to a clean pre-authorization request submitted by a physician or representative of a physician are reviewed and determined by a physician who meets all of the following requirements, in addition to the requirements set forth in paragraph (e)(1) of this section: a. Possesses a current, unrestricted license in good standing to practice medicine in any United States jurisdiction. b. Was not directly involved in making the adverse determination under appeal. c. Reviews and considers all clinical aspects of the health-care service under appeal, including all medical records of the covered person submitted as part of the pre-authorization process. (3) When a clean pre-authorization request is submitted by a health-care provider other than a physician, an adverse determination or review in an appeal from an adverse determination must be made by a health-care provider licensed in the same or similar profession as the health-care provider submitting the request for pre-authorization, or a licensed health-care provider in consultation with an appropriately qualified third-party health-care provider licensed in the same or similar medical specialty as the requesting health-care provider. Any compensation paid to the health-care provider or consulting health-care provider may not be contingent upon the outcome of the review of the clean pre-authorization request or appeal from an adverse determination. (4) A utilization review entity must, within 15 days of the receipt of an appeal of an adverse determination, notify the covered person and health-care provider submitting the request for pre-authorization of determination on the appeal. If the utilization review entity cannot make a determination within the 15-day period because additional information, documentation, or medical records are required to complete a review of the health-care service under appeal, the utilization review entity must notify the covered person and health-care provider submitting the request for pre-authorization in writing within the 15-day period specifying the additional information, documentation, or medical records required to complete the determination on appeal and shall have 15 days from the receipt thereof to make a determination on the appeal and notify the covered person and health-care provider. The written notification required by this paragraph (e)(4) must include all of the following: a. A summary of the findings supporting the determination made in the appeal. b. The qualifications of any reviewer involved in making the determination in the appeal, including any license, certification, or specialty designation of any reviewer. c. The relationship between the covered person’s diagnosis or disease being treated and the review criteria used as the basis for the determination in the appeal, including the specific basis for the determination made. (5) An insurer, health-benefit plan, or health-service corporation must ensure that any utilization review entity used to perform utilization review complies with all of the following: a. Performs utilization review on weekends. b. Provides access to a medical director or other clinical decision maker Monday through Friday between the hours of 7:00 a.m. and 7:00 p.m. and during reasonable business hours Saturday through Sunday. c. Has established procedures for the submission of appeals in writing, electronically, or by telephone. d. Provides a minimum of 30 days from the date of an adverse determination for the submission of an appeal.

Del. Code tit. 18, § 3373 Utilization review entity’s obligation with respect to pre-authorization [For application of this section, see 85 Del. Laws, c. 176, § 4].

(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 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 5 business days of receipt of a clean pre-authorization not submitted using services described in § 3377 of this title. 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 3 business days of receipt of a clean pre-authorization submitted using services described in § 3377 of this title. 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. (d) If a utilization review entity requires pre-authorization of an urgent 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 24 hours of receipt of a clean pre-authorization submitted using services described in § 3377 of this title. 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. (e) (1) If a utilization review entity requires pre-authorization of a patient transfer, 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 24 hours of receipt of a clean pre-authorization submitted using services described in § 3377 of this title. 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. (2) Notwithstanding the provisions in paragraph (e)(1) of this section, when an insurer, health-benefit plan, or health-service corporation has determined that a lower level of care at a health-care facility is clinically appropriate, the insurer, health-benefit plan, or health-service corporation may not require pre-authorization for medically necessary interfacility transport of the covered person. (f) If a utilization review entity requires pre-authorization of an urgent 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 48 hours of receipt of a clean pre-authorization submitted not using services described in § 3377 of this title. 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. (g) If a utilization review entity requires pre-authorization of a patient transfer, the 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 48 hours of receipt of a clean pre-authorization not submitted using services described in § 3377 of this title. 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.

Del. Code tit. 18, § 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.

Del. Code tit. 18, § 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.

Del. Code tit. 18, § 3376 Effect and length of pre-authorization; limitation per episode of care [For application of this section, see 85 Del. Laws, c. 176, § 4].

(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 90 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. (c) Limitation per episode of care. — An insurer, health-benefit plan, or health-service corporation may not require more than 1 pre-authorization for an episode of care. Any new treatment or additional testing or procedures related o r unrelated to the specific medical problem, condition, or illness being managed may require a separate pre-authorization. (d) Pre-authorization of other covered services in-network. — If a utilization review entity gives pre-authorization of a health-care service as part of a group of services for which a bundled payment is charged, pre-authorization of all other covered health-care services provided by in-network providers included in the group is deemed to be approved.

Del. Code tit. 18, § 3377 Electronic standards for pre-authorization [For application of this section, see 85 Del. Laws, c. 176, § 4].

(a) 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. (b) No later than January 1, 2027, an insurer, health-benefit plan, health-service corporation, or utilization review entity must allow for and accept electronic pre-authorization requests and must respond to electronic pre-authorization requests through the same website, mobile application, digital platform, or other method as the electronic pre-authorization request was submitted. (c) No later than January 1, 2027, an insurer, health-benefit plan, health-service corporation, or utilization review entity must establish a provider portal that includes all of the following features: (1) Electronic submission of pre-authorization requests. (2) Access to the insurer’s, health-benefit plan’s, health-service corporation’s, or utilization review entity’s applicable medical policies. (3) Information necessary to request a peer-to-peer review. (4) Contact information for the insurer’s, health-benefit plan’s, health-service corporation’s, or utilization review entity’s relevant clinical or administrative staff. (5) For any health-care service that requires pre-authorization that is not subject to electronic submission via the provider portal, copies of applicable forms. (6) Instructions for the submission of pre-authorization requests if the insurer’s, health-benefit plan’s, health-service corporation’s, or utilization review entity’s provider portal is unavailable for any reason. (d) Within 12 months following establishment of a provider portal under subsection (c) of this section, the insurer, health-benefit plan, health-service corporation, or utilization review entity may require a health-care provider seeking pre-authorization to submit the request via the provider portal unless 1 of the following exemptions applies: (1) The portal is not available and operational at the time of attempted submission. (2) The health-care provider does not have access to the insurer’s, health-benefit plan’s, health-service corporation’s, or utilization review entity’s operational provider portal. (3) The health-care provider satisfies an allowance by the insurer, health-benefit plan, health service corporation, or utilization review entity for submission other than through the provider portal.

Del. Code tit. 18, § 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.

Del. Code tit. 18, § 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.

Del. Code tit. 18, § 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.

Del. Code tit. 18, § 3381 Step therapy exception process [For application of this section, see 82 Del. Laws, c. 44, § 3].

(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 either of the following: a. An AB-rated generic equivalent or an “interchangeable” biological product as defined in 42 U.S.C. § 262 prior to providing coverage for the equivalent branded prescription drug. b. A “biosimilar” as defined in 42 U.S.C. § 262 prior to providing coverage for the brand name prescription reference product drug or drugs. (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.

Source: DE Code (Official Site)URL: https://delcode.delaware.gov/title18/c033/sc01/index.htmlFetched: 10/4/2026