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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsJanuary 2018

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18 DE Admin. Code 1301
At 21 DE Reg. 192 (September 1, 2017), the Department published its first notice of intent to amend Regulation 1301 and solicited written comments from the public for thirty (30) days as mandated by 29 Del.C. §10118(a). The Department's docket number is DOI Docket No. 3571-2017.
In its first notice, the Department proposed to amend the definition of "Authorized Representative" and the content of the notice to be provided by insurance carriers to their insureds. These proposed amendments implement Section 3 of HB 100, which amended 18 Del.C. §332 to now require that an insurance carrier, when informing a covered person of its internal review process, must inform the covered person of the availability of assistance from the Delaware Department of Justice (DOJ) in the preparation of an appeal of an adverse determination involving treatment for substance abuse.
In response to the comments received, the Department gave notice in the Delaware Register of Regulations at 21 DE Reg. 400 (11/01/17) of the re-proposal of amendments to Regulation 1301 with additional amendments that incorporate commenters' suggestions. The re-proposal of amendments to companion Regulation 1315 were published at 21 DE Reg. 406 (11/01/17).
The Commissioner finds that it is appropriate to adopt proposed amendments to 18 DE Admin. Code 1301 as proposed. The Department received no adverse comments on the amendments as re-proposed and the amendments as re-proposed appropriately implement Section 3 of HB 100. See elsewhere in this issue of the Delaware Register of Regulations for the adoption of amendment to companion Regulation 1315.
The 15th day of December, 2017
The purpose of this Regulation is to implement 18 Del.C. §§332, 6408, 6416 and 6417 which require health insurance carriers to establish a procedure for internal review of a carrier’s adverse coverage determination and which require the Delaware Insurance Department to establish and administer procedures for independent utilization review upon completion of the carrier’s internal review process. This Regulation is promulgated pursuant to 18 Del.C. §§311, 332, 6408, 6416, and 6417 and 29 Del.C. Ch. 101. This Regulation should not be construed to create any cause of action not otherwise existing at law.
2.1 The following words and terms, when used in this regulation, should have the following meaning unless the context clearly indicates otherwise:
Adverse determination” means a decision by a carrier to deny (in whole or in part), reduce, limit or terminate health insurance benefits or a 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.
Appeal” means a request for external review of a carrier’s final coverage decision through the Independent Health Care Appeals Program.
Appropriateness of services” means an appeal classification for adverse determinations that are made based on identification of treatment as cosmetic, investigational, experimental or not an appropriate or preferred treatment method or setting for the condition for which treatment is sought.
Authorized representative” means an individual who whom a covered person willingly acknowledges to represent his interests during the internal review process and/or an appeal through the arbitration process or the Independent Health Care Appeals Program, including but not limited to a provider to whom a covered person has assigned the right to collect sums due from a carrier for health care services rendered by the provider to the covered person. A carrier may require the covered person to submit written verification of his consent to be represented. If a covered person has been determined by a physician to be incapable of assigning the right of representation, the covered person may be represented by a family member or a legal representative. In cases involving the existence or scope of private or public coverage for substance abuse treatment, assistance may be provided by or through the Delaware Department of Justice as an authorized representative, regardless of whether the covered person has been determined by a physician to be incapable of assigning the right of representation. The Department of Justice may be reached by calling 302-577-4206, by visiting, or by email at
Carrier” means any entity that provides health insurance in this State. Carrier includes an insurance company, health service corporation, 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 insurance.
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.
Department” means the Delaware Insurance Department.
Final coverage decision” means the decision by a carrier at the conclusion of its internal review process upholding, modifying or reversing its adverse determination.
Grievance” means a request by a covered person or his authorized representative that a carrier review an adverse determination by means of the carrier’s internal review process.
Health care services” 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.
Health insurance” means a plan or policy issued by a carrier for the payment for, provision of, or reimbursement for health care services.
Independent Health Care Appeals Program (“IHCAP”)” means a program administered by the Department that provides for an external review by an Independent Utilization Review Organization of a carrier’s final coverage decision based on medical necessity or appropriateness of services.
Independent Utilization Review Organization (“IURO”)” means an entity that conducts independent external reviews of a carrier’s final coverage decisions resulting in a denial, termination, or other limitation of covered health care services based on medical necessity or appropriateness of services.
Internal review process (“IRP”)” means a procedure established by a carrier for internal review of an adverse determination.
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:
Pre-Authorization” is a requirement by a carrier or health insurance plan that states physicians need to submit a treatment plan or service request to the carrier for evaluation of appropriateness of the plan or service before treatment is rendered. It lets the insured and physician know in advance which procedures are covered.
Provider” means an individual or entity, including without limitation, a licensed physician, a licensed nurse, a licensed physician assistant and a licensed nurse practitioner, a licensed diagnostic facility, a licensed clinical facility, and a licensed hospital, who or which provides health care services in this State.
3.1 In addition to the requirements set forth in 18 Del.C. §332, the following provisions of this section shall govern the internal review process of all carriers offering health insurance in Delaware:
3.13.2 All written procedures and forms utilized by a carrier shall be readable and understandable by a person of average intelligence and education. All such documents shall meet the following criteria: The type size shall not be smaller than 11 point; The type style selection shall be at the discretion of the carrier but shall be of a type that is clear and legible; Captions or headings shall be designed to stand out clearly; White space separating subjects or sections should be distinct; There must be included a table of contents sufficient to guide and assist the covered person or his authorized representative; Where appropriate, definitions shall be included, shall be sufficient to clearly apply to the usage intended, and shall not conflict with the definitions contained in this regulation.; and The forms shall be written in everyday, conversational language to the extent possible to preserve the legal meaning. Short familiar words shall be used and sentences shall be kept as short and simple as possible.
3.23.3 The carrier shall provide all forms relating to grievances, appeals, arbitration or other procedures relating to IRP as examples along with the written notice of IRP provided to the covered person.
3.33.4 Written notice. For any IRP not previously approved by the Department, the carrier shall provide written notice of the IRP to all covered persons within 30 days of approval by the Department. The carrier shall provide the notice required by 18 Del.C. §332(c)(1) to covered persons following any adverse determination, and annually, either upon the policy renewal date, open enrollment date, or a set date for all covered persons, in the carrier’s discretion. In addition to the requirements set forth in 18 Del.C. §332(c)(1), the notice shall also, at a minimum, provide as follows: You have the right to seek a review of a claim reduction or denial through this insurer’s internal review process. For every new policy issued after the Department’s approval of the IRP, the carrier shall provide covered persons with a copy of the IRP at the time, or prior to the time, the carrier sends identification cards, member handbooks or similar member materials to newly covered persons. When a covered person’s dependents are also covered, a single notice to the principal covered person shall be sufficient under this section.
3.43.5 Under circumstances where an oral or written grievance may not contain sufficient information and the carrier requests additional information, such request shall not be burdensome or require such information as the carrier might reasonably be expected to obtain through its normal claims process.
4.0 Mediation Services Notice Requirements for Appeal of a Carrier’s Final Coverage Decision
At the time a carrier provides to a covered person written notice of a carrier's final coverage decision, if the final coverage decision does not authorize payment of the claim in its entirety, the carrier shall provide the covered person with a written notice of the process by which a covered person may appeal the carrier's final coverage decision. The notice shall include a statement that mediation services are offered by the Department. Such notice may be separate from or a part of the written notice of the carrier's decision.
Any The notice provided to a covered person shall, at a minimum, contain the following language:
“You have the right to seek a review of a claim reduction or denial through the Delaware Insurance Department. The Delaware Insurance Department also provides free informal mediation services which are in addition to, but do not replace, your right to a review of this decision through an external review or through the Department's arbitration program, as applicable. You can contact the Delaware Insurance Department for information about claim denial review or mediation by calling the Consumer Services Division at 800‑282‑8611 or 302‑739‑4251 302-674-7310.
All requests for review through procedures established by the Delaware Insurance Department the Department’s arbitration program must be filed with the Department within 60 days from the date you receive this carrier’s notice;, otherwise, this decision will be final. All requests for external review must be filed with this carrier within four months of your receipt of this final coverage decision.”
5.7.1 the The qualifications of the members of the review panel;
5.7.2 a A general description of the reason for the request for external review;
5.7.3 the The date the IURO received the assignment from the Department to conduct the external review;
5.7.4 the The date(s) the external review was conducted;
5.7.5 the The date of its decision;
5.7.6 the The principal reason(s) for its decision; and
5.7.7 references References to the evidence or documentation, including practice guidelines and clinical review criteria, considered in reaching its decision.
7.1 The Department may refuse to accept any appeal that is not timely filed or does not otherwise meet the criteria for IHCAP review. If the subject of the appeal is appropriate for arbitration, the Department shall advise the covered person or his authorized representative of the arbitration procedure. If the subject of the appeal is appropriate for arbitration, the appeal shall be treated as a petition for arbitration. the appeal concerns Concerns a benefit that is the subject of an express written exclusion from the covered person’s health insurance; the appeal is Is appropriate for arbitration; or the appeal should Should be dismissed because it is inappropriate for IHCAP review as explained in a sworn statement by an officer of the carrier. dismiss Dismiss the appeal and notify the covered person or his authorized representative in writing that the appeal is inappropriate for the IHCAP; or appoint Appoint an IURO to conduct a full external review.
9.2 An IURO seeking approval to conduct IHCAP reviews shall submit an application to the Department that includes the information required by 18 Del.C. §§6417(c)(1), 6417(c)(2), 6417(c)(4), and a copy of its certification by URAC or other nationally recognized certification organization.
9.4.7 National Any national, state or local trade association of health benefit plans or health-care providers. the The date received; name Name and plan identification number of the covered person on whose behalf the grievance was filed; a A general description of the reason for the grievance; and the The date and description of the final coverage decision. the The date received; name Name and plan identification number of the covered person on whose behalf the appeal was filed; a A general description of the reason for the appeal; and date Date and description of the IURO’s decision or other disposition of the appeal. the total number of final coverage decisions upheld Upheld through IHCAP; and the total number of final coverage decisions reversed Reversed through IHCAP.
11.1 A carrier shall not disenroll, terminate or in any way penalize a covered person who exercises his or her rights to file a grievance or appeal for IHCAP review solely on the basis of such filing.
Nothing in this Regulation shall supersede any federal or state law or regulation governing the privacy of health information.
This regulation shall become effective 10 days after being published as a final regulation. The amendments to Sections 3.0 and 4.0 of this regulation and to the definition of "Authorized representative," all of which implement HB 100, 81 Del. Laws, Ch. 28 §3 (May 30, 2017) shall become effective 10 days after being published as a final regulation and shall sunset on January 1, 2020 unless expressly reauthorized prior to that date.
Last Updated: December 31 1969 19:00:00.
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