(a) General requirements.

(1)  In cases where the non-administrative, adverse benefit determination or the final internal level of appeal to reverse a non-administrative, adverse benefit determination is unsuccessful, the healthcare entity or review agent shall provide for an external appeal by an independent review organization (IRO) approved by the commissioner and ensure that the external appeal complies with all applicable laws and regulations.

(2)  In order to seek an external appeal, claimant must have exhausted the internal claims and appeal process unless the utilization review agent or healthcare entity has waived the internal appeal process by failing to comply with the internal appeal process or the claimant has applied for expedited external review at the same time as applying for expedited internal review.

(3)  A claimant shall have at least four (4) months after receipt of a notice of the decision on a final internal appeal to request an external appeal by an IRO.

(4)  Healthcare entities and review agents must use a rotational IRO registry system specified by the commissioner, and must select an IRO in the rotational manner described in the IRO registry system.

(5)  A claimant requesting an external appeal may be charged no more than a twenty-five dollar ($25.00) external appeal fee by the review agent. The external appeal fee, if charged, must be refunded to the claimant if the adverse benefit determination is reversed through external review. The external appeal fee must be waived if payment of the fee would impose an undue financial hardship on the beneficiary. In addition, the annual limit on external appeal fees for any beneficiary within a single plan year (in the individual market, within a policy year) must not exceed seventy-five dollars ($75.00). Notwithstanding the aforementioned, this subsection shall not apply to excepted benefits as defined in 42 U.S.C. § 300gg-91(c).

(6)  IRO and/or the review agent and/or the healthcare entity may not impose a minimum dollar amount of a claim for a claim to be eligible for external review by an IRO.

(7)  The decision of the external appeal by the IRO shall be binding on the healthcare entity and/or review agent; however, any person who is aggrieved by a final decision of the external appeal agency is entitled to judicial review in a court of competent jurisdiction.

(8)  The healthcare entity must provide benefits (including making payment on the claim) pursuant to an external review decision without delay regardless whether the healthcare entity or review agent intends to seek judicial review of the IRO decision.

(9)  The commissioner shall promulgate rules and regulations including, but not limited to, criteria for designation, operation, policy, oversight, and termination of designation as an IRO. The IRO shall not be required to be certified under this chapter for activities conducted pursuant to its designation.

(b)  The external appeal process shall include, but not be limited to, the following characteristics:

(1)  The claimant must be noticed that he/she shall have at least five (5) business days from receipt of the external appeal notice to submit additional information to the IRO.

(2)  The IRO must notice the claimant of its external appeal decision to uphold or overturn the review agency decision:

(i)  No more than ten (10) calendar days from receipt of all the information necessary to complete the external review and not greater than forty-five (45) calendar days after the receipt of the request for external review; and

(ii)  In the event of an expedited external appeal by the IRO for urgent or emergent care, as expeditiously as possible and no more than seventy-two (72) hours after the receipt of the request for the external appeal by the IRO. Notwithstanding provisions in this section to the contrary, this notice may be made orally but must be followed by a written decision within forty-eight (48) hours after oral notice is given.

(3)  For an external appeal of an internal appeal decision that a drug is not covered, the IRO shall complete the external appeal determination and notify the claimant of its determination:

(i)  No later than seventy-two (72) hours following receipt of the external appeal request; or

(ii)  No later than twenty-four (24) hours following the receipt of the external appeal request if the original request was an expedited request; and

(iii)  If approved on external appeal, coverage of the non-formulary drug must be provided for the duration of the prescription, including refills, unless expedited then for the duration of the exigencies.

(c) External appeal decision notifications.  The healthcare entity and review agent must ensure that the IRO adheres to the following relative to decision notifications:

(1)  May be written or electronic with reasonable assurance of receipt by claimant unless urgent or emergent. If urgent or emergent, oral notification is acceptable followed by written or electronic notification within three (3) calendar days;

(2)  Must be culturally and linguistically appropriate;

(3)  The details of claim that is being denied to include the date of service, provider name, amount of claim, diagnostic code, and treatment costs with corresponding meanings;

(4)  Must include the specific reason or reasons for the external appeal decision;

(5)  Must include information for claimant as to procedure to obtain copies of any and all information relevant to the external appeal which copies must be provided to the claimant free of charge; and

(6)  Must not be written in a manner that could reasonably be expected to negatively impact the beneficiary.