20:06:53:01.  Definitions. Terms used in this chapter mean:

          (1)  "Adverse determination," a determination by a health carrier or its designee utilization review organization that an admission, availability of care, continued stay, or other health care service that is a covered benefit has been reviewed and, based upon the information provided, does not meet the health carrier's requirements for medical necessity, appropriateness, health care setting, level of care, or effectiveness, and the requested service or payment for the service is therefore denied, reduced, or terminated. A rescission of coverage is an adverse determination;

          (2)  "Ambulatory review," utilization review of health care services performed or provided in an outpatient setting;

          (3)  "Authorized representative," any person to whom a covered person has given express written consent to represent the covered person in an external review; any person authorized by law to provided substituted consent for a covered person; or any family member of the covered person or the covered person's treating health care professional, but only if the covered person is unable to provide consent;

          (4)  "Best evidence," evidence based on:

              (a)  Randomized clinical trials;

              (b)  If randomized clinical trials are not available, cohort studies or case-control studies;

              (c)  If subsections (a) and (b) are not available, case-series; or

              (d)  If subsections (a), (b), and (c) are not available, expert opinion;

          (5)  "Case-control study," a retrospective evaluation of two groups of patients with different outcomes to determine which specific interventions the patients received;

          (6)  "Case management," a coordinated set of activities conducted for individual patient management of serious, complicated, protracted, or other health conditions;

          (7)  "Case-series," an evaluation of a series of patients with a particular outcome, without the use of a control group;

          (8)  "Certification," a determination by a health carrier or its designee utilization review organization that an admission, availability of care, continued stay, or other health care service has been reviewed and, based on the information provided, satisfies the health carrier's requirements for medical necessity, appropriateness, health care setting, level of care, and effectiveness;

          (9)  "Clinical review criteria," the written screening procedures, decision abstracts, clinical protocols, and practice guidelines used by a health carrier to determine the necessity and appropriateness of health care services;

          (10)  "Cohort study," a prospective evaluation of two groups of patients with only one group of patients receiving a specific intervention;

          (11)  "Concurrent review," utilization review conducted during a patient's hospital stay or course of treatment;

          (12)  "Covered benefits" or "benefits," those health care services to which a covered person is entitled under the terms of a health benefit plan;

          (13)  "Covered person," a policyholder, subscriber, enrollee, or other individual participating in a health benefit plan;

          (14)  "Discharge planning," the formal process for determining, prior to discharge from a facility, the coordination and management of the care that a patient receives following discharge from a facility;

          (15)  "Disclose," to release, transfer, or otherwise divulge protected health information to any person other than the individual who is the subject of the protected health information;

          (16)  "Emergency medical condition," the sudden and, at the time, unexpected onset of a health condition or illness that requires immediate medical attention, where failure to provide medical attention would result in a serious impairment to bodily functions, serious dysfunction of a bodily organ or part, or would place the person's health in serious jeopardy;

          (17)  "Emergency services," health care items and services furnished or required to evaluate and treat an emergency medical condition;

          (18)  "Evidence-based standard," the conscientious, explicit, and judicious use of the current best evidence based on the overall systematic review of the research in making decisions about the care of individual patients;

          (19)  "Expert opinion," a belief or an interpretation by specialists with experience in a specific area about the scientific evidence pertaining to a particular service, intervention, or therapy;

          (20)  "Facility," an institution providing health care services or a health care setting, including, hospitals and other licensed inpatient centers, ambulatory surgical or treatment centers, skilled nursing centers, residential treatment centers, diagnostic, laboratory, and imaging centers, and rehabilitation and other therapeutic health settings;

          (21)  "Final adverse determination," an adverse determination involving a covered benefit that has been upheld by a health carrier, or its designee utilization review organization, at the completion of the health carrier's internal grievance process procedures as set forth in SDCL 58-17I-1 to 58-17I-16, inclusive;

          (22)  "Health benefit plan," a policy, contract, certificate, or agreement offered or issued by a health carrier to provide, deliver, arrange for, pay for, or reimburse any of the costs of health care services;

          (23)  'Health care professional," a physician or other health care practitioner licensed, accredited, or certified to perform specified health care services consistent with state law;

          (24)  "Health care provider" or "provider," a health care professional or a facility;

          (25)  "Health care services," services for the diagnosis, prevention, treatment, cure or relief of a health condition, illness, injury, or disease;

          (26)  "Health information," information or data, whether oral or recorded in any form or medium, and personal facts or information about events or relationships that relates to:

              (a)  The past, present, or future physical, mental, or behavioral health or condition of an individual or a member of the individual's family;

              (b)  The provision of health care services to an individual; or

              (c)  Payment for the provision of health care services to an individual;

          (27)  "Independent review organization," an entity that conducts independent external reviews of adverse determinations and final adverse determinations;

          (28)  "Medical or scientific evidence," evidence found in the following sources:

              (a)  Peer-reviewed scientific studies published in, or accepted for publication by, medical journals that meet nationally recognized requirements for scientific manuscripts and that submit most of their published articles for review by experts who are not part of the editorial staff;

              (b)  Peer-reviewed medical literature, including literature relating to therapies reviewed and approved by a qualified institutional review board, biomedical compendia, and other medical literature that meet the criteria of the National Institutes of Health's Library of Medicine for indexing in Index Medicus (Medline) and Elsevier Science Ltd. for indexing in Excerpta Medicus (EMBASE);

              (c)  Medical journals recognized by the Secretary of Health and Human Services under Section 1861(t)(2) of the federal Social Security Act;

              (d)  The following standard reference compendia:

                      (i)    The American Hospital Formulary Service-Drug Information;

                      (ii)   Drug Facts and Comparisons;

                      (iii)  The American Dental Association Accepted Dental Therapeutics; and

                      (iv)  The United States Pharmacopoeia-Drug Information;

              (e)  Findings, studies, or research conducted by or under the auspices of federal government agencies and nationally recognized federal research institutes, including:

                      (i)     The federal Agency for Healthcare Research and Quality;

                      (ii)    The National Institutes of Health;

                      (iii)   The National Cancer Institute;

                      (iv)   The National Academy of Sciences;

                      (v)    The Centers for Medicare & Medicaid Services;

                      (vi)   The federal Food and Drug Administration; and

                      (vii)  Any national board recognized by the National Institutes of Health for the purpose of evaluating the medical value of health care services; or

              (f)  Any other medical or scientific evidence that the director determines is comparable to the sources listed in subsections (a) to (e), inclusive;

          (29)  "NAIC," the National Association of Insurance Commissioners;

          (30)  "Prospective review," utilization review conducted prior to an admission or a course of treatment;

          (31)  "Protected health information," health information:

              (a)  That identifies an individual who is the subject of the information; or

              (b)  With respect to which there is a reasonable basis to believe that the information could be used to identify an individual;

          (32)  "Randomized clinical trial," a controlled, prospective study of patients that have been randomized into an experimental group and a control group at the beginning of the study with only the experimental group of patients receiving a specific intervention, which includes study of the groups for variables and anticipated outcomes over time;

          (33)  "Retrospective review," a review of medical necessity conducted after services have been provided to a patient, but does not include the review of a claim that is limited to an evaluation of reimbursement levels, veracity of documentation, accuracy of coding, or adjudication for payment;

          (34)  "Second opinion," an opportunity or requirement to obtain a clinical evaluation by a provider other than the one originally making a recommendation for a proposed health care service to assess the clinical necessity and appropriateness of the initial proposed health care service;

          (35)  "Utilization review," a set of formal techniques designed to monitor the use of, or evaluate the clinical necessity, appropriateness, efficacy, or efficiency of, health care services, procedures, or settings. Techniques may include ambulatory review, prospective review, second opinion, certification, concurrent review, case management, discharge planning, or retrospective review;

          (36)  "Utilization review organization," an entity that conducts utilization review, other than a health carrier performing a review of its own health benefit plan.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:02.  Applicability. Except as otherwise provided in this section, this chapter applies to any plan of individual health coverage, including any health benefit plans subject to the provisions of SDCL 58-17-66 to 58-17-87, inclusive, that is not an excepted benefit pursuant to SDCL 58-17-69(13) and any employer based health plan, including health benefit plans subject to the provisions of SDCL 58-18-42. This chapter does not apply to self funded plans preempted from state regulation pursuant to the Employee Retirement Income Security Act of 1974. Nothing in §§ 20:06:53:01 to 20:06:53:67 applies to grandfathered plans pursuant to 75 Fed. Reg. 116 (2010) to be codified as 26 C.F.R. § 54 and 602, 29 C.F.R. § 2590, and 45 C.F.R. § 147.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-18-87.

          Law Implemented: SDCL 58-18-42, 58-18-51.1.

          20:06:53:04.  Content of notices. The health carrier shall include in the notice required under § 20:06:53:03:

          (1)  For a notice related to an adverse determination, a statement informing the covered person that:

              (a)  If the covered person has a medical condition where the timeframe for completion of an expedited review of a grievance involving an adverse determination set forth in SDCL 58-17I-12 to 58-17I-15, inclusive, would seriously jeopardize the life or health of the covered person or would jeopardize the covered person's ability to regain maximum function, the covered person or the covered person's authorized representative may file a request for an expedited external review to be conducted pursuant to §§ 20:06:53:23 to 20:06:53:32, inclusive, or §§ 20:06:53:33 to 20:06:53:54, inclusive;

              (b)  If:

                      (i)    The adverse determination involves a denial of coverage based on a determination that the recommended or requested health care service or treatment is experimental or investigational and the covered person's treating physician certifies in writing that the recommended or requested health care service or treatment that is the subject of the adverse determination would be significantly less effective if not promptly initiated; and

                      (ii)   At the same time the covered person or the covered person's authorized representative files a request for an expedited review of a grievance involving an adverse determination as set forth in SDCL 58-17I-12 to 58-17I-15, inclusive, then the independent review organization assigned to conduct the expedited external review will determine whether the covered person is required to complete the expedited review of the grievance prior to conducting the expedited external review; and

              (c)  The covered person or the covered person's authorized representative may file a grievance under the health carrier's internal grievance process as set forth in SDCL 58-17I-1 to 58-17I-16, inclusive, but if the health carrier has not issued a written decision to the covered person or the covered person's authorized representative within 30 days following the date the covered person or the covered person's authorized representative files the grievance with the health carrier and the covered person or the covered person's authorized representative has not requested or agreed to a delay, the covered person or the covered person's authorized representative may file a request for external review pursuant to § 20:06:53:06 and shall be considered to have exhausted the health carrier's internal grievance process for purposes of §§ 20:06:53:07 to 20:06:53:11, inclusive; and

          (2)  For a notice related to a final adverse determination, a statement informing the covered person that:

              (a)  If the covered person has a medical condition where the timeframe for completion of a standard external review pursuant to §§ 20:06:53:12 to 20:06:53:22, inclusive, would seriously jeopardize the life or health of the covered person or would jeopardize the covered person's ability to regain maximum function, the covered person or the covered person's authorized representative may file a request for an expedited external review pursuant to §§ 20:06:53:23 to 20:06:53:32, inclusive; or

              (b)  If the final adverse determination concerns:

                      (i)    An admission, availability of care, continued stay, or health care service for which the covered person received emergency services, but has not been discharged from a facility, the covered person or the covered person's authorized representative may request an expedited external review pursuant to §§ 20:06:53:23 to 20:06:53:32, inclusive; or

                      (ii)   A denial of coverage based on a determination that the recommended or requested health care service or treatment is experimental or investigational, the covered person or the covered person's authorized representative may file a request for a standard external review to be conducted pursuant to §§ 20:06:53:33 to 20:06:53:53, inclusive, or if the covered person's treating physician certifies in writing that the recommended or requested health care service or treatment that is the subject of the request would be significantly less effective if not promptly initiated, the covered person or the covered person's authorized representative may request an expedited external review to be conducted under §§ 20:06:53:33 to 20:06:53:53, inclusive.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:05.  Review procedures and authorization to accompany notice. In addition to the information required by § 20:06:53:04, the health carrier shall include a copy of the description of both the standard and expedited external review procedures the health carrier is required to provide pursuant to § 20:06:53:67, highlighting the provisions in the external review procedures that give the covered person or the covered person's authorized representative the opportunity to submit additional information and including any forms used to process an external review.

          As part of any forms provided under this section, the health carrier shall include an authorization form, or other document approved by the director that complies with the requirements of 45 C.F.R § 164.508, by which the covered person, for purposes of conducting an external review under this chapter, authorizes the health carrier and the covered person's treating health care provider to disclose protected health information, including medical records, concerning the covered person that are pertinent to the external review, as provided in § 20:06:45:27.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:06.  Request for external review. Except for a request for an expedited external review as set forth in §§ 20:06:53:23 to 20:06:53:32, all requests for external review shall be made in writing to the director.

          The form to be used for external review requests is in Appendix B. A covered person or the covered person's authorized representative may make a request for an external review of an adverse determination or final adverse determination.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:07.  Exhaustion of internal grievance process required. Except as provided in §§ 20:06:53:09 to 20:06:53:11, inclusive, a request for an external review pursuant to §§ 20:06:53:12 to 20:06:53:53, inclusive, may not be made until the covered person has exhausted the health carrier's internal grievance process as set forth in SDCL 58-17I-1 to 58-17I-16, inclusive.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16- 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:08.  When exhaustion of internal grievance occurs. A covered person shall be considered to have exhausted the health carrier's internal grievance process for purposes of this section, if the covered person or the covered person's authorized representative:

          (1)  Has filed a grievance involving an adverse determination pursuant to SDCL 58-17I-7 to 58-17I-11, inclusive; and

          (2)  Except to the extent the covered person or the covered person's authorized representative requested or agreed to a delay, has not received a written decision on the grievance from the health carrier within 30 days following the date the covered person or the covered person's authorized representative filed the grievance with the health carrier. However, a covered person or the covered person's authorized representative may not make a request for an external review of an adverse determination involving a retrospective review determination made pursuant to SDCL 58-17I-7 to 58-17I-11, inclusive, until the covered person has exhausted the health carrier's internal grievance process.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:09.  Request for expedited review. At the same time a covered person or the covered person's authorized representative files a request for an expedited review of a grievance involving an adverse determination as set forth in SDCL 58-17I-12 to 58-17I-15, inclusive, the covered person or the covered person's authorized representative may file a request for an expedited external review of the adverse determination based upon:

          (1)  Under §§ 20:06:53:23 to 20:06:53:32, inclusive, if the covered person has a medical condition where the timeframe for completion of an expedited review of the grievance involving an adverse determination set forth in SDCL 58-17I-12 to 58-17I-15, inclusive, would seriously jeopardize the life or health of the covered person or would jeopardize the covered person's ability to regain maximum function; or

          (2)  Under §§ 20:06:53:33 to 20:06:53:53, inclusive, if the adverse determination involves a denial of coverage based on a determination that the recommended or requested health care service or treatment is experimental or investigational and the covered person's treating physician certifies in writing that the recommended or requested health care service or treatment that is the subject of the adverse determination would be significantly less effective if not promptly initiated.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:10.  Determination of expedited review. Upon receipt of a request for an expedited external review pursuant to § 20:06:53:09, the independent review organization conducting the external review in accordance with the provisions of §§ 20:06:53:23 to 20:06:53:32, inclusive, or §§ 20:06:53:33 to 20:06:53:54, inclusive, shall determine whether the covered person is required to complete the expedited review process set forth in SDCL 58-17I-12 to 58-17I-15, inclusive, before it conducts the expedited external review.

          Upon a determination made pursuant to this section, the independent review organization immediately shall notify the covered person and, if applicable, the covered person's authorized representative of this determination and that it will not proceed with the expedited external review set forth in §§ 20:06:53:23 to 20:06:53:32, inclusive, until completion of the expedited grievance review process and the covered person's grievance at the completion of the expedited grievance review process remains unresolved.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:11.  Waiver of exhaustion requirement. A request for an external review of an adverse determination may be made before the covered person has exhausted the health carrier's internal grievance procedures as set forth in SDCL 58-17I-7 to 58-17I-11, inclusive, whenever the health carrier agrees to waive the exhaustion requirement. If the requirement to exhaust the health carrier's internal grievance procedures is waived under this section, the covered person or the covered person's authorized representative may file a request in writing for a standard external review as set forth in §§ 20:06:53:12 to 20:06:53:22, inclusive, or §§ 20:06:53:33 to 20:06:53:54, inclusive.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:12.  Standard external review. At any time during the four months after the date of receipt of a notice of an adverse determination or final adverse determination pursuant to §§ 20:06:53:03 to 20:06:53:05, inclusive, a covered person or the covered person's authorized representative may file a request for an external review with the director. Within one business day after the date of receipt of a request for external review pursuant to this section, the director shall send a copy of the request to the health carrier.

          Within five business days following the date of receipt of the copy of the external review request from the director under this section, the health carrier shall complete a preliminary review of the request to determine whether:

          (1)  The individual is or was a covered person in the health benefit plan at the time the health care service was requested or, in the case of a retrospective review, was a covered person in the health benefit plan at the time the health care service was provided;

          (2)  The health care service that is the subject of the adverse determination or the final adverse determination is a covered service under the covered person's health benefit plan, but for a determination by the health carrier that the health care service is not covered because it does not meet the health carrier's requirements for medical necessity, appropriateness, health care setting, level of care, or effectiveness;

          (3)  The covered person has exhausted the health carrier's internal grievance process as set forth in SDCL 58-17I-1 to 58-17I-16, inclusive, unless the covered person is not required to exhaust the health carrier's internal grievance process pursuant to §§ 20:06:53:07 to 20:06:53:11, inclusive; and

          (4)  The covered person has provided all the information and forms required to process an external review, including the release form provided under §§ 20:06:53:04 and 20:06:53:05.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:13.  Notification following preliminary review. Within one business day after completion of the preliminary review, the health carrier shall notify the director and covered person and, if applicable, the covered person's authorized representative in writing whether:

          (1)  The request is complete; and

          (2)  The request is eligible for external review.

          If the request is not complete, the health carrier shall inform the covered person and, if applicable, the covered person's authorized representative and the director in writing and include in the notice what information or materials are needed to make the request complete. If the request is not eligible for external review, the health carrier shall inform the covered person, if applicable, the covered person's authorized representative and the director in writing and include in the notice the reasons for its ineligibility.

          The notice of initial determination shall include a statement informing the covered person and, if applicable, the covered person's authorized representative that a health carrier's initial determination that the external review request is ineligible for review may be appealed to the director.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:14.  Determination by the director and assignment of independent review organization. The director may determine that a request is eligible for external review under § 20:06:53:12 notwithstanding a health carrier's initial determination that the request is ineligible and require that it be referred for external review. In making a determination under this section, the director's decision shall be made in accordance with the terms of the covered person's health benefit plan and is subject to all applicable provisions of this chapter.

          Whenever the director receives a notice that a request is eligible for external review following the preliminary review conducted pursuant to § 20:06:53:13, within one business day after the date of receipt of the notice, the director shall:

          (1)  Assign an independent review organization from the list of approved independent review organizations compiled and maintained by the director pursuant to §§ 20:06:53:55 and 20:06:53:56, to conduct the external review and notify the health carrier of the name of the assigned independent review organization; and

          (2)  Notify in writing the covered person and, if applicable, the covered person's authorized representative of the request's eligibility and acceptance for external review. The director shall include in the notice provided to the covered person and, if applicable, the covered person's authorized representative a statement that the covered person or the covered person's authorized representative may submit in writing to the assigned independent review organization at any time during the five business days following the date of receipt of the notice provided pursuant to § 20:06:53:14 additional information that the independent review organization shall consider when conducting the external review. The independent review organization is not required to, but may, accept and consider additional information submitted after five business days.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:15.  Independence of review decision. In reaching a decision, the assigned independent review organization is not bound by any decisions or conclusions reached during the health carrier's utilization review process as set forth in SDCL 58-17H-1 to 58-17H-49, inclusive, or the health carrier's internal grievance process as set forth in SDCL 58-17I-1 to 58-17I-16, inclusive.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:16.  Health carrier required to provide information. Within five business days after the date of receipt of the notice provided pursuant to § 20:06:53:14, the health carrier or its designee utilization review organization shall provide to the assigned independent review organization any documents and any information considered in making the adverse determination or final adverse determination.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:17.  Effect of failure to act on external review process. The failure by the health carrier or its utilization review organization to provide the documents and information within the time specified in § 20:06:53:16 may not delay the conduct of the external review except as follows:

          (1)  If the health carrier or its utilization review organization fails to provide the documents and information within the time specified in § 20:06:53:16, the assigned independent review organization may terminate the external review and make a decision to reverse the adverse determination or final adverse determination; or

          (2)  Within one business day after making the decision under subdivision (1), the independent review organization shall notify the covered person, if applicable, the covered person's authorized representative, the health carrier, and the director.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:18.  Independent review organization review of information. The assigned independent review organization shall review all of the information and documents received pursuant to § 20:06:53:16 and any other information submitted in writing to the independent review organization by the covered person or the covered person's authorized representative pursuant to § 20:06:53:14. Upon receipt of any information submitted by the covered person or the covered person's authorized representative pursuant to § 20:06:53:14, the assigned independent review organization shall within one business day forward the information to the health carrier.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:19.  Carrier reconsideration. Upon receipt of the information, if any, required to be forwarded pursuant to § 20:06:53:18, the health carrier may reconsider its adverse determination or final adverse determination that is the subject of the external review. Reconsideration by the health carrier of its adverse determination or final adverse determination pursuant to this section may not delay or terminate the external review.

          The external review may only be terminated if the health carrier decides, upon completion of its reconsideration, to reverse its adverse determination or final adverse determination and provide coverage or payment for the health care service that is the subject of the adverse determination or final adverse determination. Within one business day after making a decision to reverse its adverse determination or final adverse determination, as provided in this section, the health carrier shall notify the covered person, if applicable, the covered person's authorized representative, the assigned independent review organization, and the director in writing of its decision.

          The assigned independent review organization shall terminate the external review upon receipt of the notice of a reversal from the health carrier sent pursuant to this section.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:20.  Information to be considered by independent review organization. In addition to the documents and information provided pursuant to §§ 20:06:53:16 and 20:06:53:17, the assigned independent review organization, to the extent the information or documents are available and the independent review organization considers them appropriate, shall consider the following in reaching a decision:

          (1)  The covered person's medical records;

          (2)  The attending health care professional's recommendation;

          (3)  Consulting reports from appropriate health care professionals and other documents submitted by the health carrier, covered person, the covered person's authorized representative, or the covered person's treating provider;

          (4)  The terms of coverage under the covered person's health benefit plan with the health carrier to ensure that the independent review organization's decision is not contrary to the terms of coverage under the covered person's health benefit plan with the health carrier;

          (5)  The most appropriate practice guidelines, which shall include applicable evidence-based standards and may include any other practice guidelines developed by the federal government, national or professional medical societies, boards, and associations;

          (6)  Any applicable clinical review criteria developed and used by the health carrier or its designee utilization review organization; and

          (7)  The opinion of the independent review organization's clinical reviewer or reviewers after considering subdivisions (1) to (6), inclusive, to the extent the information or documents are available and the clinical reviewer or reviewers consider appropriate.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:21.  Independent review organization decisions. Within 45 days after the date of receipt of the request for an external review, the assigned independent review organization shall provide written notice of its decision to uphold or reverse the adverse determination or the final adverse determination to the covered person, the covered person's authorized representative, the health carrier, and the director.

          The independent review organization shall include in the notice sent pursuant to this section the following:

          (1)  A general description of the reason for the request for external review;

          (2)  The date the independent review organization received the assignment from the director to conduct the external review;

          (3)  The date the external review was conducted;

          (4)  The date of its decision;

          (5)  The principal reason or reasons for its decision, including what applicable, if any, evidence-based standards were a basis for its decision;

          (6)  The rationale for its decision; and

          (7)  References to the evidence or documentation, including the evidence-based standards, considered in reaching its decision.

          Upon receipt of a notice of a decision pursuant to this section reversing the adverse determination or final adverse determination, the health carrier immediately shall approve the coverage that was the subject of the adverse determination or final adverse determination.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:22.  Director assignment of independent review organization. The assignment by the director of an approved independent review organization to conduct an external review in accordance with this section shall be done on a random basis among those approved independent review organizations qualified to conduct the particular external review based on the nature of the health care service that is the subject of the adverse determination or final adverse determination and other circumstances, including conflict of interest concerns pursuant to § 20:06:53:60.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:23.  Expedited external review. Except for retrospective adverse or final adverse determinations, a covered person or the covered person's authorized representative may make a request for an expedited external review with the director at the time the covered person receives:

          (1)  An adverse determination if:

              (a)  The adverse determination involves a medical condition of the covered person for which the timeframe for completion of an expedited internal review of a grievance involving an adverse determination set forth in SDCL 58-17I-12 to 58-17I-15, inclusive, would seriously jeopardize the life or health of the covered person or would jeopardize the covered person's ability to regain maximum function; and

              (b)  The covered person or the covered person's authorized representative has filed a request for an expedited review of a grievance involving an adverse determination as set forth in SDCL 58-17H-1 to 58-17H-16, inclusive; or

          (2)  A final adverse determination:

              (a)  If the covered person has a medical condition where the timeframe for completion of a standard external review pursuant to §§ 20:06:53:12 to 20:06:53:22, inclusive, would seriously jeopardize the life or health of the covered person or would jeopardize the covered person's ability to regain maximum function; or

              (b)  If the final adverse determination concerns an admission, availability of care, continued stay, or health care service for which the covered person received emergency services, but has not been discharged from a facility.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:24.  Notifications upon request for expedited external review. Upon receipt of a request for an expedited external review, the director immediately shall send a copy of the request to the health carrier. Immediately upon receipt of the request from the director, the health carrier shall determine whether the request meets the reviewability requirements set forth in § 20:06:53:12. The health carrier shall immediately notify the director and the covered person and, if applicable, the covered person's authorized representative of its eligibility determination.

          The notice of initial determination shall include a statement informing the covered person and, if applicable, the covered person's authorized representative that a health carrier's initial determination that an external review request is ineligible for review may be appealed to the director.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:25.  Director's determination of eligibility for expedited reviews. The director may determine that a request is eligible for external review and under § 20:06:53:12 notwithstanding a health carrier's initial determination that the request is ineligible and require that it be referred for external review. In making a determination under this section, the director's decision is made in accordance with the terms of the covered person's health benefit plan and is subject to all applicable provisions of this chapter.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:26.  Director assignment of independent review organization for expedited reviews. Upon receipt of a notice that the request meets the reviewability requirements, the director immediately shall assign an independent review organization to conduct the expedited external review from the list of approved independent review organizations compiled and maintained by the director pursuant to §§ 20:06:53:55 and 20:06:53:56. The director shall immediately notify the health carrier of the name of the assigned independent review organization.

          Upon receipt of the notice from the director of the name of the independent review organization assigned to conduct the expedited external review pursuant to this section, the health carrier or its designee utilization review organization shall provide or transmit all necessary documents and information considered in making the adverse determination or final adverse determination to the assigned independent review organization electronically or by telephone or facsimile or any other available expeditious method.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:27.  Independent review organization decision for expedited reviews. In reaching a decision in accordance with §§ 20:06:53:29 and 20:06:53:30, the assigned independent review organization is not bound by any decisions or conclusions reached during the health carrier's utilization review process as set forth in SDCL 58-17H-1 to 58-17H-49, inclusive, or the health carrier's internal grievance process as set forth in SDCL 58-17I-1 to 58-17I-16, inclusive.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:28.  Information to be considered by independent review organization for expedited review. In addition to the documents and information provided or transmitted pursuant to § 20:06:53:26, the assigned independent review organization, to the extent the information or documents are available and the independent review organization considers them appropriate, shall consider the following in reaching a decision:

          (1)  The covered person's pertinent medical records;

          (2)  The attending health care professional's recommendation;

          (3)  Consulting reports from appropriate health care professionals and other documents submitted by the health carrier, covered person, the covered person's authorized representative, or the covered person's treating provider;

          (4)  The terms of coverage under the covered person's health benefit plan with the health carrier to ensure that the independent review organization's decision is not contrary to the terms of coverage under the covered person's health benefit plan with the health carrier;

          (5)  The most appropriate practice guidelines, which shall include evidence-based standards, and may include any other practice guidelines developed by the federal government, or national or professional medical societies, boards, and associations;

          (6)  Any applicable clinical review criteria developed and used by the health carrier or its designee utilization review organization in making adverse determinations; and

          (7)  The opinion of the independent review organization's clinical reviewer or reviewers after considering subdivisions (1) to (6), inclusive, to the extent the information or documents are available and the clinical reviewer or reviewers consider appropriate.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:29.  Expedited review decision. As expeditiously as the covered person's medical condition or circumstances requires, but in no event more than 72 hours after the date of receipt of the request for an expedited external review that meets the reviewability requirements set forth in § 20:06:53:12, the assigned independent review organization shall:

          (1)  Make a decision to uphold or reverse the adverse determination or final adverse determination; and

          (2)  Notify the covered person, if applicable, the covered person's authorized representative, the health carrier, and the director of the decision. If the notice provided was not in writing, within 48 hours after the date of providing that notice, the assigned independent review organization shall:

              (a)  Provide written confirmation of the decision to the covered person, if applicable, the covered person's authorized representative, the health carrier, and the director; and

              (b)  Include the information set forth in § 20:06:53:21.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:30.  Health carrier required to approve upon reversal by expedited review. Upon receipt of the notice a decision pursuant to § 20:06:53:29 reversing the adverse determination or final adverse determination, the health carrier immediately shall approve the coverage that was the subject of the adverse determination or final adverse determination.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:31.  Assignment of independent review organization for expedited reviews. The assignment by the director of an approved independent review organization to conduct an external review in accordance with this section shall be done on a random basis among those approved independent review organizations qualified to conduct the particular external review based on the nature of the health care service that is the subject of the adverse determination or final adverse determination and other circumstance, including conflict of interest concerns pursuant to § 20:06:53:60.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:32.  Applicability of expedited reviews. An expedited external review may not be provided for retrospective adverse or final adverse determinations. Sections 20:06:53:23 to 20:06:53:31, inclusive, only apply to expedited reviews.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:33.  External review of experimental or investigational treatment adverse determinations. Within four months after the date of receipt of a notice of an adverse determination or final adverse determination pursuant to §§ 20:06:53:03 to 20:06:53:05, inclusive, that involves a denial of coverage based on a determination that the health care service or treatment recommended or requested is experimental or investigational, a covered person or the covered person's authorized representative may file a request for external review with the director.

          A covered person or the covered person's authorized representative may make an oral request for an expedited external review of the adverse determination or final adverse determination pursuant to this section if the covered person's treating physician certifies, in writing, that the recommended or requested health care service or treatment that is the subject of the request would be significantly less effective if not promptly initiated.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:34.  Notifications upon request for external review of experimental or investigational treatment adverse determinations. Upon receipt of a request for an expedited external review, the director immediately shall notify the health carrier. Upon notice of the request for expedited external review, the health carrier immediately shall determine whether the request meets the reviewability requirements of § 20:06:53:36. The health carrier shall immediately notify the director and the covered person and, if applicable, the covered person's authorized representative of its eligibility determination.

          The notice of initial determination by the health carrier under this section shall include a statement informing the covered person and, if applicable, the covered person's authorized representative that a health carrier's initial determination that the external review request is ineligible for review may be appealed to the director.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:35.  Director's determination of eligibility and assignment for external review of experimental or investigational treatment. The director may determine that a request is eligible for external review under § 20:06:53:36 notwithstanding a health carrier's initial determination the request is ineligible and require that it be referred for external review. In making a determination under this section, the director's decision shall be made in accordance with the terms of the covered person's health benefit plan and is subject to all applicable provisions of this chapter.

          Upon receipt of the notice that the expedited external review request meets the reviewability requirements of § 20:06:53:36, the director immediately shall assign an independent review organization to review the expedited request from the list of approved independent review organizations compiled and maintained by the director pursuant to §§ 20:06:53:55 and 20:06:53:56 and notify the health carrier of the name of the assigned independent review organization.

          At the time the health carrier receives the notice of the assigned independent review organization pursuant to this section, the health carrier or its designee utilization review organization shall provide or transmit all necessary documents and information considered in making the adverse determination or final adverse determination to the assigned independent review organization electronically or by telephone or facsimile or any other available expeditious method.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:36.  Health carrier preliminary review of request for experimental or investigational treatment reviews. Except for a request for an expedited external review made pursuant to §§ 20:06:53:33 to 20:06:53:35, inclusive, within one business day after the date of receipt of the request, the director receives a request for an external review, the director shall notify the health carrier. Within five business days following the date of receipt of the notice sent pursuant to this section, the health carrier shall conduct and complete a preliminary review of the request to determine whether:

          (1)  The individual is or was a covered person in the health benefit plan at the time the health care service or treatment was recommended or requested or, in the case of a retrospective review, was a covered person in the health benefit plan at the time the health care service or treatment was provided;

          (2)  The recommended or requested health care service or treatment that is the subject of the adverse determination or final adverse determination:

              (a)  Is a covered benefit under the covered person's health benefit plan except for the health carrier's determination that the service or treatment is experimental or investigational for a particular medical condition; and

              (b)  Is not explicitly listed as an excluded benefit under the covered person's health benefit plan with the health carrier;

          (3)  The covered person's treating physician has certified that one of the following situations is applicable:

              (a)  Standard health care services or treatments have not been effective in improving the condition of the covered person;

              (b)  Standard health care services or treatments are not medically appropriate for the covered person; or

              (c)  There is no available standard health care service or treatment covered by the health carrier that is more beneficial than the recommended or requested health care service or treatment described in subdivision (4) of this section;

          (4)  The covered person's treating physician:

              (a)  Has recommended a health care service or treatment that the physician certifies, in writing, is likely to be more beneficial to the covered person, in the physician's opinion, than any available standard health care services or treatments; or

              (b)  Who is a licensed, board certified or board eligible physician qualified to practice in the area of medicine appropriate to treat the covered person's condition, has certified in writing that scientifically valid studies using accepted protocols demonstrate that the health care service or treatment requested by the covered person that is the subject of the adverse determination or final adverse determination is likely to be more beneficial to the covered person than any available standard health care services or treatments;

          (5)  The covered person has exhausted the health carrier's internal grievance process as set forth in SDCL 58-17I-1 to 58-17I-16, inclusive, unless the covered person is not required to exhaust the health carrier's internal grievance process pursuant to §§ 20:06:53:07 to 20:06:53:21, inclusive; and

          (6)  The covered person has provided all the information and forms required by the director that are necessary to process an external review, including the release form provided under §§ 20:06:53:04 and 20:06:53:05.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:37.  Health carrier notification after preliminary review of request for experimental or investigational treatment reviews. Within one business day after completion of the preliminary review, the health carrier shall notify the director and the covered person and, if applicable, the covered person's authorized representative in writing whether the request is complete and whether the request is eligible for external review.

          If the request is not complete, the health carrier shall inform, in writing, the director and the covered person and, if applicable, the covered person's authorized representative and include in the notice what information or materials are needed to make the request complete.

          If the request is not eligible for external review, the health carrier shall inform the covered person, the covered person's authorized representative, if applicable, and the director in writing and include in the notice the reasons for its ineligibility.

          The notice of initial determination provided under this section must include a statement informing the covered person and, if applicable, the covered person's authorized representative that a health carrier's initial determination that the external review request is ineligible for review may be appealed to the director.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:38.  Director's determination of request for experimental or investigational treatment reviews. The director may determine that a request is eligible for external review pursuant to § 20:06:53:36, notwithstanding a health carrier's initial determination that the request is ineligible and require that it be referred for external review. In making a determination under this section, the director's decision shall be made in accordance with the terms of the covered person's health benefit plan and is subject to all applicable provisions of this chapter.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:39.  Health carrier notification of eligibility for experimental or investigational treatment reviews. Whenever a request for external review is determined eligible for external review, the health carrier shall notify the director and the covered person and, if applicable, the covered person's authorized representative. Within one business day after the receipt of the notice from the health carrier that the external review request is eligible for external review pursuant to § 20:06:53:35 or this section, the director shall:

          (1)  Assign an independent review organization to conduct the external review from the list of approved independent review organizations compiled and maintained by the director pursuant to §§ 20:06:53:55 and 20:06:53:56 and notify the health carrier of the name of the assigned independent review organization; and

          (2)  Notify in writing the covered person and, if applicable, the covered person's authorized representative of the request's eligibility and acceptance for external review.

          The director shall include in the notice provided to the covered person and, if applicable, the covered person's authorized representative a statement that the covered person or the covered person's authorized representative may submit in writing to the assigned independent review organization within five business days following the date of receipt of the notice provided pursuant to this section additional information that the independent review organization shall consider when conducting the external review. The independent review organization is not required to, but may, accept and consider additional information submitted after five business days.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:40.  Independent review organization experimental or investigational treatment reviews. Within one business day after the receipt of the notice of assignment to conduct the external review pursuant to § 20:06:53:39, the assigned independent review organization shall:

          (1)  Select one or more clinical reviewers, as it determines is appropriate, pursuant to this section to conduct the external review; and

          (2)  Based on the opinion of the clinical reviewer, or opinions if more than one clinical reviewer has been selected to conduct the external review, make a decision to uphold or reverse the adverse determination or final adverse determination.

          In selecting clinical reviewers pursuant to this section, the assigned independent review organization shall select physicians or other health care professionals who meet the minimum qualifications described in §§ 20:06:53:57 to 20:06:53:62, inclusive, and, through clinical experience in the past three years, are experts in the treatment of the covered person's condition and knowledgeable about the recommended or requested health care service or treatment. Neither the covered person, the covered person's authorized representative, if applicable, nor the health carrier may choose or control the choice of the physicians or other health care professionals to be selected to conduct the external review.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:41.  Independent review organization clinical reviewer written opinion for experimental or investigational treatment review. In accordance with §§ 20:06:53:45 and 20:06:53:46, each clinical reviewer shall provide a written opinion to the assigned independent review organization on whether the recommended or requested health care service or treatment should be covered. In reaching an opinion, clinical reviewers are not bound by any decisions or conclusions reached during the health carrier's utilization review process as set forth in SDCL 58-17H-1 to 58-17H-49, inclusive.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:42.  Records provided to independent review organization for experimental or investigational treatment reviews. Within five business days after the date of receipt of the notice provided pursuant to § 20:06:53:39, the health carrier or its designee utilization review organization shall provide to the assigned independent review organization, the documents and any information considered in making the adverse determination or the final adverse determination. Except as provided in this section, failure by the health carrier or its designee utilization review organization to provide the documents and information within the five day timeframe may not delay the conduct of the external review.

          If the health carrier or its designee utilization review organization has failed to provide the documents and information within the time specified in this section, the assigned independent review organization may terminate the external review and make a decision to reverse the adverse determination or final adverse determination. Immediately upon making the decision under this section, the independent review organization shall notify the covered person, the covered person's authorized representative, if applicable, the health carrier, and the director.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:43.  Review of information by independent review organization for experimental or investigational treatment reviews. Each clinical reviewer selected pursuant to §§ 20:06:53:39 to 20:06:53:41, inclusive, shall review all of the information and documents received pursuant to § 20:06:53:42 and any other information submitted in writing by the covered person or the covered person's authorized representative pursuant to § 20:06:53:39. Upon receipt of any information submitted by the covered person or the covered person's authorized representative pursuant to § 20:06:53:39, within one business day after the receipt of the information, the assigned independent review organization shall forward the information to the health carrier.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:44.  Reconsideration by health carrier for experimental or investigational treatment reviews. Upon receipt of the information required to be forwarded pursuant to § 20:06:53:43, the health carrier may reconsider its adverse determination or final adverse determination that is the subject of the external review. Reconsideration by the health carrier of its adverse determination or final adverse determination pursuant to this section may not delay or terminate the external review. The external review may be terminated only if the health carrier decides, upon completion of its reconsideration, to reverse its adverse determination or final adverse determination and provide coverage or payment for the recommended or requested health care service or treatment that is the subject of the adverse determination or final adverse determination.

          Immediately upon making the decision to reverse its adverse determination or final adverse determination, as provided in this section, the health carrier shall notify the covered person, the covered person's authorized representative, if applicable, the assigned independent review organization, and the director, in writing, of its decision.

          The assigned independent review organization shall terminate the external review upon receipt of the notice from the health carrier's decision to reverse its adverse determination or final adverse determination.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:45.  Clinical review opinion for experimental or investigational treatment reviews. Except as provided in § 20:06:53:44, within 20 days after being selected in accordance with §§ 20:06:53:39 to 20:06:53:41, inclusive, to conduct the external review, each clinical reviewer shall provide an opinion to the assigned independent review organization pursuant to § 20:06:53:47 on whether the recommended or requested health care service or treatment should be covered. Except for an opinion provided pursuant to § 20:06:53:46, each clinical reviewer's opinion shall be in writing and include the following information:

          (1)  A description of the covered person's medical condition;

          (2)  A description of the indicators relevant to determining whether there is sufficient evidence to demonstrate that the recommended or requested health care service or treatment is more likely than not to be beneficial to the covered person than any available standard health care services or treatments and the adverse risks of the recommended or requested health care service or treatment would not be substantially increased over those of available standard health care services or treatments;

          (3)  A description and analysis of any medical or scientific evidence, as that term is defined in subdivision 20:06:53:01(28), considered in reaching the opinion;

          (4)  A description and analysis of any evidence-based standard, as that term is defined in subdivision 20:06:53:01(18); and

          (5)  Information on whether the reviewer's rationale for the opinion is based on subsection 20:06:53:47(5)(a) or (b).

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:46.  Expedited review opinions for experimental or investigational treatment reviews. For an expedited external review, each clinical reviewer shall provide an opinion orally or in writing to the assigned independent review organization as expeditiously as the covered person's medical condition or circumstances requires, but in no event more than five calendar days after being selected in accordance with §§ 20:06:53:39 to 20:06:53:41, inclusive. If the opinion provided pursuant to this section was not in writing, within 48 hours following the date the opinion was provided, the clinical reviewer shall provide written confirmation of the opinion to the assigned independent review organization and include the information as required under § 20:06:53:45.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:47.  Clinical review criteria for experimental or investigational treatment reviews. In addition to the documents and information provided pursuant to §§ 20:06:53:33 to 20:06:53:35, inclusive, or § 20:06:53:42, each clinical reviewer selected pursuant to §§ 20:06:53:39 to 20:06:53:41, inclusive, to the extent the information or documents are available and the reviewer considers appropriate, shall consider in reaching an opinion pursuant to §§ 20:06:53:45 and 20:06:53:46, the following:

          (1)  The covered person's pertinent medical records;

          (2)  The attending physician or health care professional's recommendation;

          (3)  Consulting reports from appropriate health care professionals and other documents submitted by the health carrier, covered person, the covered person's authorized representative, or the covered person's treating physician or health care professional;

          (4)  The terms of coverage under the covered person's health benefit plan with the health carrier to ensure that, but for the health carrier's determination that the recommended or requested health care service or treatment that is the subject of the opinion is experimental or investigational, the reviewer's opinion is not contrary to the terms of coverage under the covered person's health benefit plan with the health carrier; and

          (5)  Whether:

              (a)  The recommended or requested health care service or treatment has been approved by the federal Food and Drug Administration, if applicable, for the condition; or

              (b)  Medical or scientific evidence or evidence-based standards demonstrate that the expected benefits of the recommended or requested health care service or treatment is more likely than not to be beneficial to the covered person than any available standard health care service or treatment and the adverse risks of the recommended or requested health care service or treatment would not be substantially increased over those of available standard health care services or treatments.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:48.  Independent review organization decision and notice for experimental or investigational treatment reviews. Except as provided in § 20:06:53:49, within 20 days after the date it receives the opinion of each clinical reviewer pursuant to § 20:06:53:47, the assigned independent review organization, in accordance with § 20:06:53:50, shall make a decision and provide written notice of the decision to the covered person, the covered person's authorized representative, the health carrier, and the director.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:49.  Expedited reviews upon receipt of clinical review opinion for experimental or investigational treatment reviews. For an expedited external review, within 48 hours after the date it receives the opinion of each clinical reviewer pursuant to § 20:06:53:47, the assigned independent review organization, in accordance with § 20:06:53:50, shall make a decision and provide notice of the decision orally or in writing to the persons listed in § 20:06:53:48.

          If the notice provided under this section was not in writing, within 48 hours after the date of providing that notice, the assigned independent review organization shall provide written confirmation of the decision to the persons listed in § 20:06:53:48 and include the information set forth in § 20:06:53:51.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:50.  Decision by independent review organization for experimental or investigational treatment reviews. If a majority of the clinical reviewers recommend that the recommended or requested health care service or treatment should be covered, the independent review organization shall make a decision to reverse the health carrier's adverse determination or final adverse determination. If a majority of the clinical reviewers recommend that the recommended or requested health care service or treatment should not be covered, the independent review organization shall make a decision to uphold the health carrier's adverse determination or final adverse determination.

          If the clinical reviewers are evenly split as to whether the recommended or requested health care service or treatment should be covered, the independent review organization shall obtain the opinion of an additional clinical reviewer in order for the independent review organization to make a decision based on the opinions of a majority of the clinical reviewers.

          The additional clinical reviewer selected under this section shall use the same information to reach an opinion as the clinical reviewers who have already submitted their opinions pursuant to § 20:06:53:47. The selection of the additional clinical reviewer under this section does not extend the time within which the assigned independent review organization is required to make a decision based on the opinions of the clinical reviewers selected under §§ 20:06:53:39 to 20:06:53:41, inclusive.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:51.  Notice of written decision by independent review organization for experimental or investigational treatment reviews. The independent review organization shall include in the notice provided pursuant to §§ 20:06:53:48 and 20:06:53:49:

          (1)  A general description of the reason for the request for external review;

          (2)  The written opinion of each clinical reviewer, including the recommendation of each clinical reviewer as to whether the recommended or requested health care service or treatment should be covered and the rationale for the reviewer's recommendation:

          (3)  The date the independent review organization was assigned by the director to conduct the external review;

          (4)  The date the external review was conducted;

          (5)  The date of its decision;

          (6)  The principal reason or reasons for its decision; and

          (7)  The rationale for its decision.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:52.  Health carrier requirement upon notice of decision reversing adverse determination for experimental or investigational treatment reviews. Upon receipt of a notice of a decision pursuant to §§ 20:06:53:48 and 20:06:53:49 reversing the adverse determination or final adverse determination, the health carrier immediately shall approve coverage of the recommended or requested health care service or treatment that was the subject of the adverse determination or final adverse determination.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:53.  Criteria for assignment of independent review organization for experimental or investigational treatment reviews. The assignment by the director of an approved independent review organization to conduct an external review in accordance with §§ 20:06:53:33 to 20:06:53:54, inclusive, shall be done on a random basis among those approved independent review organizations qualified to conduct the particular external review based on the nature of the health care service that is the subject of the adverse determination or final adverse determination and other circumstances, including conflict of interest concerns pursuant to § 20:06:53:60.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:54.  Binding nature of external review decision. An external review decision is binding on the health carrier except to the extent the health carrier has other remedies available under applicable state law. An external review decision is binding on the covered person except to the extent the covered person has other remedies available under applicable federal or state law.

          A covered person or the covered person's authorized representative may not file a subsequent request for external review involving the same adverse determination or final adverse determination for which the covered person has already received an external review decision pursuant to this chapter.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:55.  Approval of independent review organizations. The director shall approve independent review organizations eligible to be assigned to conduct external reviews pursuant to this chapter. In order to be eligible for approval by the director under this section to conduct external reviews pursuant to this chapter an independent review organization, except as otherwise provided in §§ 20:06:53:55 and 20:06:53:56, shall be accredited by a nationally recognized private accrediting entity that the director has determined has independent review organization accreditation standards that are equivalent to or exceed the minimum qualifications for independent review organizations established pursuant to §§ 20:06:53:57 to 20:06:53:62, inclusive; and

          Any independent review organization wishing to be approved to conduct external reviews pursuant to this chapter shall submit an application form as prescribed by the director and include with the form all documentation and information necessary for the director to determine if the independent review organization satisfies the minimum qualifications established pursuant to §§ 20:06:53:57 to 20:06:53:62, inclusive.

          The director may approve independent review organizations that are not accredited by a nationally recognized private accrediting entity if there are no acceptable nationally recognized private accrediting entities providing independent review organization accreditation.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:56.  Continuation of approval for independent review organizations. An approval is effective for two years, unless the director determines before its expiration that the independent review organization is not satisfying the minimum qualifications established pursuant to §§ 20:06:53:57 to 20:06:53:62, inclusive.

          Whenever the director determines that an independent review organization has lost its accreditation or no longer satisfies the minimum requirements established pursuant to §§ 20:06:53:57 to 20:06:53:62, inclusive, the director shall terminate the approval of the independent review organization and remove the independent review organization from the list of independent review organizations approved to conduct external reviews pursuant to this chapter that is maintained by the director pursuant to § 20:06:53:62.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:57.  Minimum qualifications for independent review organizations. To be approved under §§ 20:06:53:55 and 20:06:53:56 to conduct external reviews, an independent review organization shall have and maintain written policies and procedures that govern all aspects of both the standard external review process and the expedited external review process set forth in this chapter. The policies and procedures shall include, at a minimum:

          (1)  A quality assurance mechanism in place that:

              (a)  Ensures that external reviews are conducted within the specified timeframes and required notices are provided in a timely manner;

              (b)  Ensures the selection of qualified and impartial clinical reviewers to conduct external reviews on behalf of the independent review organization and suitable matching of reviewers to specific cases and that the independent review organization employs or contracts with an adequate number of clinical reviewers to meet this objective;

              (c)  Ensures the confidentiality of medical and treatment records and clinical review criteria; and

              (d)  Ensures that any person employed by or under contract with the independent review organization adheres to the requirements of this chapter;

          (2)  A toll-free telephone service to receive information on a 24-hour-day, 7-day-a-week basis related to external reviews that is capable of accepting, recording, or providing appropriate instruction to incoming telephone callers during other than normal business hours; and

          (3)  An agreement to maintain and provide to the director the information set out in §§  20:06:53:64 and 20:06:53:65.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:58.  Requirements for clinical reviewers. All clinical reviewers assigned by an independent review organization to conduct external reviews shall be physicians or other appropriate health care providers who meet the following minimum qualifications:

          (1)  Be an expert in the treatment of the covered person's medical condition that is the subject of the external review;

          (2)  Be knowledgeable about the recommended health care service or treatment through recent or current actual clinical experience treating patients with the same or similar medical condition of the covered person;

          (3)  Hold a non-restricted license in a state of the United States and, for physicians, a current certification by a recognized American medical specialty board in the area or areas appropriate to the subject of the external review; and

          (4)  Have no history of disciplinary actions or sanctions, including loss of staff privileges or participation restrictions, that have been taken or are pending by any hospital, governmental agency or unit, or regulatory body that raise a substantial question as to the clinical reviewer's physical, mental, or professional competence or moral character.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:59.  Subsidiaries of or ownership in independent review organizations. In addition to the requirements set forth in § 20:06:53:57, an independent review organization may not own or control, be a subsidiary of, or in any way be owned or controlled by, or exercise control with, a health benefit plan, a national, state, or local trade association of health benefit plans, or a national, state, or local trade association of health care providers.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:60.  Independence of clinical reviewers. In addition to the requirements set forth in §§ 20:06:53:57, 20:06:53:58, and 20:06:53:59, to be approved pursuant to §§ 20:06:52:55 and 20:06:53:56 to conduct an external review of a specified case, neither the independent review organization selected to conduct the external review nor any clinical reviewer assigned by the independent organization to conduct the external review may have a material professional, familial, or financial conflict of interest with any of the following;

          (1)  The health carrier that is the subject of the external review;

          (2)  The covered person whose treatment is the subject of the external review or the covered person's authorized representative;

          (3)  Any officer, director, or management employee of the health carrier that is the subject of the external review;

          (4)  The health care provider or the health care provider's medical group or independent practice association recommending the health care service or treatment that is the subject of the external review;

          (5)  The facility at which the recommended health care service or treatment would be provided; or

          (6)  The developer or manufacturer of the principal drug, device, procedure, or other therapy being recommended for the covered person whose treatment is the subject of the external review.

          In determining whether an independent review organization or a clinical reviewer of the independent review organization has a material professional, familial, or financial conflict of interest for purposes of this section, the director shall take into consideration situations where the independent review organization to be assigned to conduct an external review of a specified case or a clinical reviewer to be assigned by the independent review organization to conduct an external review of a specified case may have an apparent professional, familial, or financial relationship or connection with a person described in this section, but that the characteristics of that relationship or connection are such that they are not a material professional, familial, or financial conflict of interest that results in the disapproval of the independent review organization or the clinical reviewer from conducting the external review.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:61.  Nationally accredited independent review organizations. An independent review organization that is accredited by a nationally recognized private accrediting entity that has independent review accreditation standards that the director has determined are equivalent to or exceed the minimum qualifications of this section shall be presumed in compliance with this section to be eligible for approval under §§ 20:06:53:55 and 20:06:53:56.

          The director shall initially review and periodically review the independent review organization accreditation standards of a nationally recognized private accrediting entity to determine whether the entity's standards are, and continue to be, equivalent to or exceed the minimum qualifications established under this section. The director may accept a review conducted by the NAIC for the purpose of the determination under this section.

          Upon request, a nationally recognized private accrediting entity shall make its current independent review organization accreditation standards available to the director or the NAIC in order for the director to determine if the entity's standards are equivalent to or exceed the minimum qualifications established under this section. The director may exclude any private accrediting entity that is not reviewed by the NAIC.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:62.  Unbiased independent review organization. An independent review organization must be unbiased. An independent review organization shall establish and maintain written procedures to ensure that it is unbiased in addition to any other procedures required pursuant to §§ 20:06:53:57 to 20:06:53:62, inclusive.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:63. Hold harmless for independent review organizations. No independent review organization or clinical reviewer working on behalf of an independent review organization or an employee, agent, or contractor of an independent review organization is liable in damages to any person for any opinions rendered or acts or omissions performed within the scope of the organization's or person's duties under the law during or upon completion of an external review conducted pursuant to this chapter, unless the opinion was rendered or act or omission performed in bad faith or involved gross negligence.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:64.  External review reporting requirements. An independent review organization assigned pursuant to §§ 20:06:53:12 to 20:06:53:32, inclusive, to conduct an external review shall maintain written records in the aggregate by state and by health carrier on all requests for external review for which it conducted an external review during a calendar year and, upon request, submit a report to the director, as required under this section. The report must be in the format of Appendix C.

          Each independent review organization required to maintain written records on all requests for external review pursuant to this section for which it was assigned to conduct an external review shall submit to the director, upon request, a report in the format specified by the director. The report shall include in the aggregate by state, and for each health carrier, the following:

          (1)  The total number of requests for external review;

          (2)  The number of requests for external review resolved and, of those resolved, the number resolved upholding the adverse determination or final adverse determination and the number resolved reversing the adverse determination or final adverse determination;

          (3)  The average length of time for resolution;

          (4)  A summary of the types of coverages or cases for which an external review was sought, as provided in the format required by the director; and

          (5)  The number of external reviews pursuant to § 20:06:53:19 that were terminated as the result of a reconsideration by the health carrier of its adverse determination or final adverse determination after the receipt of additional information from the covered person or the covered person's authorized representative.

          The director may request additional information to be included within the report or to be provided at an alternate date that relates to the independent review organization's compliance with this chapter.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:65.  Independent review organization and health carrier recordkeeping. The independent review organization shall retain the written records required pursuant to § 20:06:53:64 for at least three years.

          Each health carrier shall maintain written records in the aggregate, by state and for each type of health benefit plan offered by the health carrier, on all requests for external review that the health carrier receives notice of from the director pursuant to this chapter. Each health carrier required to maintain written records on all requests for external review pursuant to this section shall submit to the director, upon request, a report in the format of Appendix D. The report shall include in the aggregate, by state, and by type of health benefit plan the following information:

          (1)  The total number of requests for external review; and

          (2)  From the total number of requests for external review reported under subdivision (1) of this section, the number of requests determined eligible for a full external review.

          The director may request additional information to be included within the report or to be provided at an alternate date that relates to the health carrier's compliance with this chapter.

          The health carrier shall retain the written records required pursuant to this section for at least three years.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:67.  Disclosure requirements. Each health carrier shall include a description of the external review procedures in or attached to the policy, certificate, membership booklet, outline of coverage, or other evidence of coverage it provides to covered persons. The description shall be in a format prescribed by the director. The description shall include a statement that informs the covered person of the right of the covered person to file a request for an external review of an adverse determination or final adverse determination with the director. The statement may explain that external review is available when the adverse determination or final adverse determination involves an issue of medical necessity, appropriateness, health care setting, level of care, or effectiveness. The statement shall include the telephone number and address of the director. The statement shall inform the covered person that, when filing a request for an external review, the covered person is required to authorize the release of any medical records of the covered person that may be required to be reviewed for the purpose of reaching a decision on the external review.

          Source: 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-17H-49, 58-17I-16, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          Commission Note: The provisions of this chapter are effective for plan years beginning after September 22, 2010.

          20:06:53:68.  Adverse benefit determination -- Defined. For purposes of §§ 20:06:53:68 to 20:06:53:77, inclusive, an adverse benefit determination is defined in SDCL 58-17H-1(1).

          Source: 37 SDR 63, effective September 23, 2010; 37 SDR 111, effective December 7, 2010; 37 SDR 241, effective July 1, 2011.

          General Authority: SDCL 58-17-87, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-17H-1, 58-18-79.

          20:06:53:69.  Urgent care requests -- Timely notification of determination -- Initial benefit determination. For an urgent care request in the context of an initial benefit determination, unless the covered person or the covered person's authorized representative has failed to provide sufficient information for the health carrier to determine whether, or to what extent, the benefits requested are covered benefits or payable under the health carrier's health benefit plan, the health carrier shall notify the covered person or, if applicable, the covered person's authorized representative of the health carrier's determination with respect to the request, whether or not the benefit determination is an adverse determination, as soon as possible, taking into account the medical condition of the covered person, but in no event later than twenty-four hours after the date of the receipt of the request by the health carrier.

          Source: 37 SDR 63, effective September 23, 2010; 37 SDR 111, effective December 7, 2010.

          General Authority: SDCL 58-17-87, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-17C-72, 58-18-79.

          20:06:53:70.  Additional evidence. The plan or issuer must provide the claimant, free of charge, with any new or additional evidence considered, relied upon, or generated by the plan or issuer or at the direction of the plan or issuer in connection with the claim. Such evidence must be provided as soon as possible and sufficiently in advance of the date on which the notice of adverse benefit determination on review is required to be provided to give the claimant a reasonable opportunity to respond prior to that date. Additionally, before the plan or issuer can issue an adverse benefit determination on review based on a new or additional rationale, the claimant must be provided, free of charge, with the rationale. The rationale must be provided as soon as possible and sufficiently in advance of the date on which the notice of adverse benefit determination on review is required to be provided to give the claimant a reasonable opportunity to respond prior to that date.

          Source: 37 SDR 63, effective September 23, 2010; 37 SDR 111, effective December 7, 2010.

          General Authority: SDCL 58-17-87, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:71.  Avoiding conflicts of interest. The plan or issuer must ensure that all claims and appeals are adjudicated in a manner designed to ensure the independence and impartiality of the persons involved in making the decision. Therefore, any decision regarding hiring, compensation, termination, promotion, or any other similar matter with respect to any individual may not be made based upon the likelihood that the individual will support a denial of benefits. A plan or issuer may not provide bonuses based on the number of denials made by a claims adjudicator. Similarly, a plan or issuer may not contract with a medical expert based on the expert's reputation for outcomes in contested cases, rather than based on the expert's professional qualifications.

          Source: 37 SDR 63, effective September 23, 2010; 37 SDR 111, effective December 7, 2010.

          General Authority: SDCL 58-17-87, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:72.  Notice to enrollee. A plan or issuer shall provide notice to enrollees, in a culturally and linguistically appropriate manner, if ten percent or more of the population residing in the claimants county are literate only in the same non-English language, as determined based on American Community Survey data published by United States Census Bureau.

          Plans and issuers must provide notice in accordance with SDCL 58-17H-32 and 58-17H-48. Insurers may comply with the notice requirements required in SDCL 58-17H-32 and 58-17H-48 by providing notification of the right to request and receive diagnoses and treatment codes and their meanings in all notices of adverse benefit determinations and final adverse benefit determinations.

          Source: 37 SDR 63, effective September 23, 2010; 37 SDR 111, effective December 7, 2010; 37 SDR 241, effective July 1, 2011; 38 SDR 59, effective October 19, 2011.

          General Authority: SDCL 58-17-87, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-17H-48, 58-18-79.

          Reference: American Community Survey data published by United States Census Bureau. www.census.gov.

          20:06:53:73.  Failure to comply with internal claims and appeal process. If a plan or issuer fails to strictly adhere to all the requirements of the internal claims and appeals process with respect to a claim, the claimant is deemed to have exhausted the internal claims and appeals process, regardless of whether the plan or issuer asserts that it substantially complied with these requirements. Upon the failure to strictly adhere to the requirements of the internal claims and appeals process, the claimant may initiate an external review and pursue any available remedies under applicable law, such as judicial review.

          The claimant is entitled upon written request to an explanation of the plan's or issuer's basis for asserting that it meets this standard. If the external review or the court rejects the claimant's request for immediate review on the basis that the plan met this standard, the claimant has the right to resubmit and pursue the internal appeal under SDCL 58-17I-7.

          Source: 37 SDR 63, effective September 23, 2010; 37 SDR 111, effective December 7, 2010; 38 SDR 59, effective October 19, 2011.

          General Authority: SDCL 58-17-87, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:74.  Continued coverage and ongoing treatment. A plan and issuer must provide continued coverage pending the outcome of an internal appeal of a concurrent review. A plan or issuer may not reduce or terminate an ongoing course of treatment without providing advance notice and an opportunity for advance review.

          Source: 37 SDR 63, effective September 23, 2010; 37 SDR 111, effective December 7, 2010.

          General Authority: SDCL 58-17-87, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:75.  One level of internal appeals. A health insurance issuer offering individual health insurance coverage may only have one level of internal appeals. A claimant may seek either external review or judicial review immediately after an adverse benefit determination is upheld in the first level of the internal appeals process.

          Source: 37 SDR 63, effective September 23, 2010; 37 SDR 111, effective December 7, 2010.

          General Authority: SDCL 58-17-87, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:76.  Record keeping. Each health insurance issuer offering individual health insurance coverage shall maintain records of all claims and notices associated with its internal claims and appeals processes. The records must be maintained for at least six years. An issuer must make such records available to the director for examination upon request. Any request for a first level review of a grievance involving an adverse benefit determination and any request for a voluntary review of a grievance involving an adverse benefit determination must be included in the health carrier's grievance register, which must be maintained in a reasonably clear and accessible manner and must contain, at a minimum, the following:

          (1)  A general description of the reason for the grievance;

          (2)  The date received;

          (3)  The date of each review or, if applicable, review meeting;

          (4)  Resolution at each level of the grievance, if applicable;

          (5)  Date of resolution at each level, if applicable; and

          (6)  Name of the covered person for whom the grievance was filed.

          Source: 37 SDR 63, effective September 23, 2010; 37 SDR 111, effective December 7, 2010.

          General Authority: SDCL 58-17-87.

          Law Implemented: SDCL 58-17-87.

          20:06:53:77.  Applicability. Nothing in §§ 20:06:53:68 to 20:06:53:76, inclusive, applies to grandfathered plans pursuant to 26 C.F.R. 54.9815-2719T, 29 C.F.R. 2590.715-27109, or 45 C.F.R. 147.36. Sections 20:06:53:68 to 20:06:53:76, inclusive, apply to any plan of individual health coverage, including any health benefit plans subject to the provisions of SDCL 58-17-66 to 58-17-87, inclusive, that is not an excepted benefit pursuant to SDCL subdivision 58-17-69(13). Sections 20:06:53:68 to 20:06:53:74, inclusive, apply to any employer based health plan, including health benefit plans subject to the provisions of SDCL 58-18-42. This chapter does not apply to self-funded plans preempted from state regulation pursuant to the Employee Retirement Income Security Act of 1974.

          Source: 37 SDR 63, effective September 23, 2010; 37 SDR 111, effective December 7, 2010.

          General Authority: SDCL 58-17-87, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-51.1, 58-18-79.

          20:06:53:78.  Strictly adhere -- Defined. For purposes of §§ 20:06:53:68 to 20:06:53:77 minor non-prejudicial errors attributable to good cause or matters beyond the plan or issuer's control in the context of ongoing good faith exchange of information and not evidence of pattern or practice of non-compliance with the internal claims and appeal process meet the strict adherence requirements of the internal claims and appeal process.

          Source: 38 SDR 59, effective October 19, 2011.

          General Authority: SDCL 58-17-87, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:79.  Written explanation of violation. A covered person may request a written explanation of the violation from the health carrier. The health carrier shall provide the written explanation within ten days of receiving the request. The written explanation shall include a specific description of its bases, if any, for asserting that the violation does not deem the provisions of SDCL 58-17I-1 to 58-17I-16 have been exhausted.

          Source: 38 SDR 59, effective October 19, 2011.

          General Authority: SDCL 58-17-87, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.

          20:06:53:80.  Procedure when immediate review request denied. If an independent reviewer or a court of competent jurisdiction rejects the grievance involving an adverse determination for immediate review on the basis that the health carrier met the requirements of the exception provided in § 20:06:53:78 the covered person has the right to resubmit and pursue a review of the grievance under SDCL 58-17I-1 to 58-17I-16. Within a reasonable time, after the independent reviewer or the court rejects the grievance involving an adverse determination for immediate review, but not exceeding ten days, the health carrier shall provide to the covered person or, if applicable, the covered person's authorized representative notice of the opportunity to resubmit and, as appropriate, pursue a review of the grievance under SDCL 58-17I-1 to 58-17I-16.

          For purposes of calculating the time period for re-filing the benefit request or claim under this subparagraph, the time period shall begin to run upon the covered person's or, if applicable, the covered person's authorized representative receipt of the notice of opportunity to resubmit.

          Source: 38 SDR 59, effective October 19, 2011.

          General Authority: SDCL 58-17-87, 58-18-79.

          Law Implemented: SDCL 58-17-87, 58-18-79.