Source: http://regulations.delaware.gov/register/november2017/proposed/21%20DE%20Reg%20400%2011-01-17.htm
Timestamp: 2019-04-24 02:53:29+00:00

Document:
Re-proposal of amendments to an existing regulation.
At 21 DE Reg 192 (September 1, 2017) the Department published a notice of its intent to amend Regulation 1301 and solicited written comments from the public for thirty (30) days as mandated by 29 Del.C. §10118(a).
In the Department's September 1 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 in the preparation of an appeal of an adverse determination involving treatment for substance abuse. HB 100 was signed into law on May 30, 2017, became effective on September 27, 2017 and sunsets on January 1, 2020 unless expressly reauthorized prior to that date. The Department also proposed non-substantive amendments to correct punctuation at subsections 3.1.6 and 9.4.6, and to correct style throughout subsections 5.7, 7.1 and 11.1, and throughout Sections 9.0 and 10.0.
The Governor's Advisory Council for Exceptional Citizens and the State Council for Persons with Disabilities submitted an identical set of comments on the substance of the proposed amendments. Both organizations endorsed the Department's proposed amendments. Following are the Department's summary of each comment and the Department's responses.
1.	COMMENT: The commenters support the Department's proposed amendments to the regulation.
RESPONSE: The Department appreciates the commenters' support.
2.	COMMENT: H.B. No. 100 (lines 37-38) contemplates retention of attorneys to represent individuals in substance abuse insurance disputes, but H.B. No. 100 (line 24) contemplates the use of "experts" in substance abuse insurance disputes. The term "expert" is not defined and could encompass professionals in the field of addiction who, under attorney supervision, could appear on a covered person's behalf in proceedings authorized by 18 DE Admin. Code 1301. Therefore, in the definition of "Authorized Representative," it may be preferable to not categorically limit Department of Justice (DOJ) assistance to attorneys.
RESPONSE: The Department agrees that the definition of "Authorized Representative" should not be limited to "an attorney retained or employed by the Delaware Department of Justice." In addition to the reasons stated by the commenters, HB 100 at lines 51-53 states that, "The written forms provided by the carrier must inform the covered person of the availability of assistance in the preparation of an appeal of an adverse determination involving treatment for substance abuse . . . (emphasis added)." This provision does not limit the assistance to legal assistance. Therefore, with this proposal the Department is amending the definition of "Authorized Representative" to reflect that assistance is available from the Department of Justice, not just legal assistance.
3.	COMMENT: The Department should consider providing a specific DOJ website address (with description of its substance abuse legal assistance program) in addition to a telephone number.
RESPONSE: The Department agrees with the comment. With this proposal, the Department will add the DOJ's website address and email address to the definition of "Authorized Representative" and in the sections that contain notice requirements.
4.	COMMENT: The notice is "buried in the boilerplate" and not prominent. To fulfill the spirit of HB 100, the Department could consider a separate heading (e.g., "Substance Abuse Treatment Denials: Special Assistance") followed by a brief explanation and DOJ contact information (website and phone number).
RESPONSE: The Department agrees that the notice provision could be clarified. With this proposal, the Department will add paragraph separators to offset the wording concerning the availability of assistance from the DOJ and will add clarifying language. The Department will also retitle section 1301-4 to more clearly convey the purpose of this section.
5.	COMMENT: The notice only informs an aggrieved person of the availability of DOJ assistance with mediation. See §4.0. This is misleading since DOJ assistance is also available in the internal review process (§3.0), IHCAP procedure (§5.0), and expedited IHCAP procedure (§6.0). Apart from carrier notice of the availability of DOJ assistance in contexts other than mediation, the Department could consider including a notice of DOJ assistance as a complement to the notice in §5.4.
RESPONSE: The Department agrees that assistance is available at all stages of review as indicated by the commenters. The definition of "Authorized representative" as proposed explicitly defines the authorized representative as "an individual who a covered person willingly acknowledges to represent his interests during the internal review process and/or an appeal through the Independent Health Care Appeals Program (emphasis added)." Additionally, with this proposal, the Department is proposing to add minimum notice requirements at subsection 3.3.2 to require that the notice of the availability of an appeal through the insurer's internal review program also include language that informs the insured of the availability of DOJ assistance at the internal review stage of a claim denial or reduction for treatment for substance abuse.
6.	COMMENT: The proposed notice indicates that DOJ assistance is only available "if you are approaching the deadline for filing your appeal." This limitation is not authorized by law and will deter requests for DOJ assistance.
RESPONSE: The Department maintains that the assistance of an "Authorized representative" is available throughout the appeals process, as discussed in the response to Comment 4. However, to the extent that the phrase "if you are approaching the deadline for filing your appeal" is misleading, the Department proposes to remove that phrase in this proposal.
7.	COMMENT: To encourage individuals to consider DOJ assistance, it would be preferable to clarify that DOJ assistance is "free." This could be easily accomplished by revising the relevant language to ". . . receive free legal assistance."
RESPONSE: The statute does not articulate whether DOJ assistance is free of charge. Accordingly, the Department lacks statutory authority to make the amendment suggested by the commenters.
In response to the comments received, the Department has determined to re-propose the amendments to Regulation 1301, with additional amendments that incorporate commenters' suggestions as noted in the above responses to comments.
The Department does not plan to hold a public hearing on the proposed amendments. The proposed amendments appear below and can also be viewed at the Department of Insurance website at http://insurance.delaware.gov/information/proposedregs/. The Department's docket number is DOI Docket No. 3571-2017. The re-proposal of companion amendments to Regulation 1315 may be viewed elsewhere in this edition of the Register of Regulations.
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.
“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 http://attorneygeneral.delaware.gov/dojtreatmentassistance/, or by email at dojtreatmentassistance@state.de.us.
“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.
“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.
“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.
C.	Not solely for anyone’s convenience.
“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.
3.1.73.2.7	The forms shall be written in everyday, conversational language to the extent possible to preserve the legal meaning.
3.1.83.2.8	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.
3.3.13.4.1	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.
3.4.2.1	You have the right to seek a review of a claim reduction or denial through this insurer’s internal review process.
3.4.2.2	If your claim involves an adverse determination involving treatment for substance abuse, you may be eligible to receive assistance by or through the Delaware Department of Justice during this company’s internal review process. The Delaware Department of Justice may be reached by calling 302-577-4206, by visiting http://attorneygeneral.delaware.gov/dojtreatmentassistance/, or by email at dojtreatmentassistance@state.de.us, for more information.
3.3.33.4.3	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.
3.3.43.4.4	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.
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.
“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.
Your decision to pursue mediation with the Department does not change the deadlines imposed for filing a request for an external review (set by Section 5.0 of this regulation) or arbitration (set by Regulation 1315 of Delaware Administrative Code Chapter 18, 18 DE Admin. Code 1315).
If your request for review involves a claim reduction or denial involving treatment for substance abuse, you may be eligible to receive assistance by or through the Delaware Department of Justice by calling 302-577-4206, by visiting http://attorneygeneral.delaware.gov/dojtreatmentassistance/, or by email at dojtreatmentassistance@state.de.us for more information.
5.1	A covered person or his authorized representative may request review of a final coverage decision based, in whole or in part, on medical necessity or appropriateness of services by filing an appeal with the carrier within four months of receipt of the final coverage decision.
5.2	Upon receipt of an appeal, the carrier shall transmit the appeal electronically to the Department as soon as possible, but within no more than three business days.
5.3	Within five calendar days of receipt of an appeal, the Department shall assign an approved, impartial Independent Utilization Review Organization to review the final coverage decision and shall notify the carrier.
5.4	The assigned IURO shall, within five calendar days of assignment, notify the covered person or his authorized representative in writing by certified or registered mail that the appeal has been accepted for external review.
5.4.1	The notice shall include a provision stating that the covered person or his authorized representative may submit additional written information and supporting documentation that the IURO shall consider when conducting the external review.
5.4.2	The covered person or his authorized representative shall submit such written documentation to the IURO within seven calendar days following the date of receipt of the notice.
5.4.3	Upon receipt of any information submitted by the covered person or his authorized representative, the assigned IURO shall as soon as possible, but within no more than two business days, forward the information to the carrier.
5.4.4	The IURO must accept additional documentation submitted by the carrier in response to additional written information and supporting documentation from the covered person or his authorized representative.
5.5	Within seven calendar days after the receipt of the notification required in subsection 5.3, the carrier shall provide to the assigned IURO the documents and any information considered in making the final coverage decision.
5.5.1	If the carrier fails to submit documentation and information or fails to participate within the time specified, the assigned IURO may terminate the external review and make a decision, with the approval of the Department, to reverse the final coverage decision.
5.6	The external review may be terminated if the carrier decides to reverse its final coverage decision and provide coverage or payment for the health care service that is the subject of the appeal.
5.6.1	Immediately upon making the decision to reverse its final coverage decision, the carrier shall notify the covered person or his authorized representative, the assigned IURO, and the Department in writing of its decision. The assigned IURO shall terminate the external review upon receipt of the written notice from the carrier.
5.7.7	references References to the evidence or documentation, including practice guidelines and clinical review criteria, considered in reaching its decision.
5.8	The decision of the IURO is binding upon the carrier except as provided in 18 Del.C. §6416(b).
6.1	A covered person or his authorized representative may request an expedited appeal at the time the carrier issues its final coverage decision if the covered person suffers from a condition that poses an imminent, emergent or serious threat or has an emergency medical condition.
6.1.1	For an emergency medical condition, the claimant may file for an external review without having already exhausted the internal appeal process. To the extent the State process requires exhaustion of an internal claims and appeals process, exhaustion must be unnecessary where the carrier (or, if applicable, the plan) has waived the requirement, the carrier (or the plan) is considered to have exhausted the internal claims and appeals process under applicable law (including by failing to comply with any of the requirements for the internal appeal process, as outlined in 45 CFR 147.136(b)(2) and (3)), or the claimant has applied for expedited external review at the same time as applying for an expedited internal appeal.
6.2	At the time the carrier receives a request for an expedited appeal, the carrier shall immediately transmit the appeal electronically to the Department, but within no more than three business days.
6.3	If the Department determines that the review meets the criteria for expedited review, the Department shall assign an approved, impartial IURO to conduct the external review and shall notify the carrier.
6.4	At the time the carrier receives the notification of the assigned IURO, the carrier shall provide or transmit all necessary documents and information considered in making its final coverage decision to the assigned IURO electronically, by telephone, by facsimile or any other available expeditious method.
6.5	As expeditiously as the covered person’s medical condition permits or circumstances require, but in no event more than 72 hours after the IURO’s receipt of the expedited appeal, the IURO shall make a decision to uphold or reverse the final coverage decision and immediately notify the covered person or his authorized representative, the carrier, and the Department of the decision.
6.6	Within one calendar day of the immediate notification, the assigned IURO shall provide written confirmation of its decision to the covered person or his authorized representative, the carrier, and the Department.
6.7	The decision of the IURO is binding upon the carrier except as provided in 18 Del.C. §6416(b).
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.
7.2	Carrier’s motion to dismiss an IHCAP appeal.
7.2.1.3	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.
7.2.2	The carrier’s motion to dismiss must be made in writing at the time the carrier transmits the appeal to the Department and must include any necessary supporting documentation.
7.2.3.2	appoint Appoint an IURO to conduct a full external review.
8.1	All costs for IHCAP review by an IURO, whether the review is preliminary, or partially or fully completed, shall be borne by the carrier.
8.1.1	These costs shall include a $75.00 administration fee for processing and handling by the Department.
8.2	The carrier shall reimburse the Department for the cost of the IHCAP review within 90 calendar days of receipt of the decision by the IURO or within 90 days of termination of review by the IURO by other means.
9.1	The Department shall approve IUROs eligible to be assigned to conduct IHCAP reviews as provided in 18 Del.C. §6417(a).
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.
9.3	The Department shall maintain a current list of approved IUROs.
9.4.7	National Any national, state or local trade association of health benefit plans or health-care providers.
10.1.1.4	the The date and description of the final coverage decision.
10.1.2.4	date Date and description of the IURO’s decision or other disposition of the appeal.
10.2.2.2	the total number of final coverage decisions reversed Reversed through IHCAP.
10.3	A carrier shall make available to the Department upon request any of the information specified in the foregoing subsections 10.1 and 10.2, and other information regarding its internal review process including but not limited to the written IRP procedures and forms the carrier distributes to covered persons.
10.4	An IURO shall make available to the Department upon request any of the information specified in the foregoing subsections 10.1 and 10.2 to the extent within the IURO’s records.
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.
11.2	A carrier shall not terminate or in any way penalize a provider with whom it has a contractual relationship and who exercises, on behalf of a covered person, the right to file a grievance or appeal for IHCAP review solely on the basis of such filing.
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.

References: §10118
 §332
 §4
 §5
 §6416
 §6416
 §6417
 §3