H.F. 597 Section 1. NEW SECTION . 514J.101 Purpose —— applicability. 1 The purpose of this chapter is to provide uniform standards 2 for the establishment and maintenance of external review 3 procedures to assure that covered persons have the opportunity 4 for an independent review of an adverse determination or final 5 adverse determination made by a health carrier as required 6 by the federal Patient Protection and Affordable Care Act, 7 Pub. L. No. 111-148, as amended by the federal Health Care and 8 Education Reconciliation Act of 2010, Pub. L. No. 111-152, 9 which amends the Public Health Service Act and adopts, in part, 10 new 42 U.S.C. § 300gg-19, and to address issues which are 11 unique to the external review process in this state. 12 Sec. 2. NEW SECTION . 514J.102 Definitions. 13 As used in this chapter, unless the context otherwise 14 requires: 15 1. “Adverse determination” means a determination by a health 16 carrier that an admission, availability of care, continued 17 stay, or other health care service that is a covered benefit 18 has been reviewed and, based upon the information provided, 19 does not meet the health carrier’s requirements for medical 20 necessity, appropriateness, health care setting, level of care, 21 or effectiveness, and the requested service or payment for the 22 service is therefore denied, reduced, or terminated. “Adverse 23 determination” does not include a denial of coverage for a 24 service or treatment specifically listed in plan or evidence 25 of coverage documents as excluded from coverage, or a denial 26 of coverage for a service or treatment that has already been 27 received and for which the covered person has no financial 28 liability. 29 2. “Authorized representative” means any of the following: 30 a. A person to whom a covered person has given express 31 written consent to represent the covered person in an external 32 review. 33 b. A person authorized by law to provide substituted consent 34 for a covered person. 35 -1- HF 597 (3) 84 av/nh/mb 1/ 41

H.F. 597 c. A family member of the covered person when the covered 1 person is unable to provide consent. 2 d. The covered person’s treating health care professional 3 when the covered person is unable to provide consent. 4 3. “Best evidence” means evidence based on randomized 5 clinical trials. If randomized clinical trials are not 6 available, “best evidence” means evidence based on cohort 7 studies or case-control studies. If randomized clinical 8 trials, cohort studies, or case-control studies are not 9 available, “best evidence” means evidence based on case-series 10 studies. If none of these are available, “best evidence” means 11 evidence based on expert opinion. 12 4. “Case-control study” means a retrospective evaluation 13 of two groups of patients with different outcomes to determine 14 which specific interventions the patients received. 15 5. “Case-series study” means an evaluation of a series 16 of patients with a particular outcome, without the use of a 17 control group. 18 6. “Certification” means a determination by a health carrier 19 that an admission, availability of care, continued stay, or 20 other health care service has been reviewed and, based on 21 the information provided, satisfies the health carrier’s 22 requirements for medical necessity, appropriateness, health 23 care setting, level of care, and effectiveness. 24 7. “Clinical review criteria” means the written screening 25 procedures, decision abstracts, clinical protocols, and 26 practice guidelines used by a health carrier to determine the 27 necessity and appropriateness of health care services. 28 8. “Cohort study” means a prospective evaluation of two 29 groups of patients with only one group of patients receiving a 30 specific intervention. 31 9. “Commissioner” means the commissioner of insurance. 32 10. “Covered benefits” or “benefits” means those health care 33 services to which a covered person is entitled under the terms 34 of a health benefit plan. 35 -2- HF 597 (3) 84 av/nh/mb 2/ 41

H.F. 597 11. “Covered person” means a policyholder, subscriber, 1 enrollee, or other individual participating in a health benefit 2 plan. 3 12. “Disclose” means to release, transfer, or otherwise 4 divulge protected health information to any person other than 5 the individual who is the subject of the protected health 6 information. 7 13. “Emergency medical condition” means the sudden and, at 8 the time, unexpected onset of a health condition or illness 9 that requires immediate medical attention, where failure to 10 provide medical attention would result in a serious impairment 11 to bodily functions, serious dysfunction of a bodily organ or 12 part, or would place the person’s health in serious jeopardy. 13 14. “Emergency services” means health care items and 14 services furnished or required to evaluate and treat an 15 emergency medical condition. 16 15. “Evidence-based standard” means the conscientious, 17 explicit, and judicious use of the current best evidence based 18 on the overall systematic review of the research in making 19 decisions about the care of individual patients. 20 16. “Expert opinion” means a belief or an interpretation 21 by specialists with experience in a specific area about 22 the scientific evidence pertaining to a particular service, 23 intervention, or therapy. 24 17. “Facility” means an institution providing health 25 care services or a health care setting, including but not 26 limited to hospitals and other licensed inpatient centers, 27 ambulatory surgical or treatment centers, skilled nursing 28 centers, residential treatment centers, diagnostic, laboratory 29 and imaging centers, and rehabilitation and other therapeutic 30 health settings. 31 18. “Final adverse determination” means an adverse 32 determination involving a covered benefit that has been upheld 33 by a health carrier at the completion of the health carrier’s 34 internal grievance process. 35 -3- HF 597 (3) 84 av/nh/mb 3/ 41

H.F. 597 19. “Health benefit plan” means a policy, contract, 1 certificate, or agreement offered or issued by a health carrier 2 to provide, deliver, arrange for, pay for, or reimburse any of 3 the costs of health care services. 4 20. “Health care professional” means a physician or other 5 health care practitioner licensed, accredited, registered, or 6 certified to perform specified health care services consistent 7 with state law. 8 21. “Health care provider” or “provider” means a health care 9 professional or a facility. 10 22. “Health care services” means services for the diagnosis, 11 prevention, treatment, cure, or relief of a health condition, 12 illness, injury, or disease. 13 23. “Health carrier” means an entity subject to the 14 insurance laws and regulations of this state, or subject 15 to the jurisdiction of the commissioner, including an 16 insurance company offering sickness and accident plans, a 17 health maintenance organization, a nonprofit health service 18 corporation, a plan established pursuant to chapter 509A 19 for public employees, or any other entity providing a plan 20 of health insurance, health care benefits, or health care 21 services. “Health carrier” includes, for purposes of this 22 chapter, an organized delivery system. 23 24. “Health information” means information or data, whether 24 oral or recorded in any form or medium, and personal facts or 25 information about events or relationships that relates to any 26 of the following: 27 a. The past, present, or future physical, mental, or 28 behavioral health or condition of a covered person or a member 29 of the covered person’s family. 30 b. The provision of health care services to a covered 31 person. 32 c. Payment to a health care provider for the provision of 33 health care services to a covered person. 34 25. “Independent review organization” means an entity that 35 -4- HF 597 (3) 84 av/nh/mb 4/ 41

H.F. 597 conducts independent external reviews of adverse determinations 1 and final adverse determinations. 2 26. “Medical or scientific evidence” means evidence found in 3 any of the following sources: 4 a. Peer-reviewed scientific studies published in or accepted 5 for publication by medical journals that meet nationally 6 recognized requirements for scientific manuscripts and that 7 submit most of their published articles for review by experts 8 who are not part of the editorial staff. 9 b. Peer-reviewed medical literature, including literature 10 relating to therapies reviewed and approved by a qualified 11 institutional review board, biomedical compendia, and other 12 medical literature that meet the criteria of the national 13 institutes of health’s national library of medicine for 14 indexing in index medicus or medline, or of elsevier science 15 ltd. for indexing in excerpta medicus or embase. 16 c. Medical journals recognized by the United States 17 secretary of health and human services under section 1861(t)(2) 18 of the federal Social Security Act. 19 d. The following standard reference compendia: 20 (1) American hospital formulary service drug information. 21 (2) Drug facts and comparisons. 22 (3) American dental association accepted dental 23 therapeutics. 24 (4) United States pharmacopoeia drug information. 25 e. Findings, studies, or research conducted by or under 26 the auspices of federal government agencies and nationally 27 recognized federal research institutes, including any of the 28 following: 29 (1) Federal agency for health care research and quality. 30 (2) National institutes of health. 31 (3) National cancer institute. 32 (4) National academy of sciences. 33 (5) Centers for Medicare and Medicaid services. 34 (6) Federal food and drug administration. 35 -5- HF 597 (3) 84 av/nh/mb 5/ 41

H.F. 597 (7) Any national board recognized by the national 1 institutes of health for the purpose of evaluating the medical 2 value of health care services. 3 f. Any other medical or scientific evidence that is 4 comparable to the sources listed in paragraphs “a” through “e” . 5 27. “NAIC” means the national association of insurance 6 commissioners. 7 28. “Organized delivery system” means an entity system 8 authorized under 1993 Iowa Acts, ch. 158, and licensed by the 9 director of public health, and performing utilization review. 10 29. “Person” means an individual, a corporation, a 11 partnership, an association, a joint venture, a joint stock 12 company, a trust, an unincorporated organization, any similar 13 entity, or any combination of the foregoing. 14 30. “Protected health information” means health information 15 that meets either of the following descriptions: 16 a. Health information that identifies a covered person who 17 is the subject of the information. 18 b. Health information with respect to which there is a 19 reasonable basis to believe that the information could be used 20 to identify a covered person. 21 31. “Randomized clinical trial” means a controlled, 22 prospective study of patients that have been randomized into an 23 experimental group and a control group at the beginning of the 24 study with only the experimental group of patients receiving a 25 specific intervention, which includes study of the groups for 26 variables and anticipated outcomes over time. 27 Sec. 3. NEW SECTION . 514J.103 Applicability and scope. 28 1. Except as provided in subsection 2, this chapter shall 29 apply to all health carriers. 30 2. This chapter shall not apply to any of the following: 31 a. A policy or certificate that provides coverage only for a 32 specified disease, specified accident or accident-only, credit, 33 disability income, hospital indemnity, long-term care, dental 34 care, vision care, or any other limited supplemental benefit. 35 -6- HF 597 (3) 84 av/nh/mb 6/ 41

H.F. 597 b. A Medicare supplement policy of insurance, as defined by 1 the commissioner by rule. 2 c. Coverage under a plan through Medicare, Medicaid, or the 3 federal employees health benefits program, any coverage issued 4 under 10 U.S.C. ch. 55, and any coverage issued as supplemental 5 to that coverage. 6 d. Any coverage issued as supplemental to liability 7 insurance. 8 e. Workers’ compensation or similar insurance. 9 f. Automobile medical-payment insurance or any insurance 10 under which benefits are payable with or without regard to 11 fault, whether written on a group blanket or individual basis. 12 Sec. 4. NEW SECTION . 514J.104 Notice of right to external 13 review. 14 1. A health carrier shall notify a covered person or the 15 covered person’s authorized representative, if known, in 16 writing of the covered person’s right to request an external 17 review and include the appropriate statements and information 18 set forth in this chapter at the time the health carrier sends 19 written notice of a final adverse determination. 20 2. a. The notice shall include the following, or 21 substantially equivalent, language: 22 We have denied your request for the provision of or payment 23 for a health care service or course of treatment. You may 24 have the right to have our decision reviewed by health care 25 professionals who have no association with us if our decision 26 involved making a judgment as to the medical necessity, 27 appropriateness, health care setting, level of care, or 28 effectiveness of the health care service or treatment you 29 requested by submitting a request for external review to the 30 commissioner of insurance. 31 b. The notice shall include the current address and contact 32 information for the commissioner as specified in administrative 33 rule. 34 3. The health carrier shall include in the notice a 35 -7- HF 597 (3) 84 av/nh/mb 7/ 41

H.F. 597 statement informing the covered person or the covered person’s 1 authorized representative, if known, of the following: 2 a. If the covered person has a medical condition pursuant 3 to which the time frame for completion of a standard external 4 review would seriously jeopardize the life or health of the 5 covered person or would jeopardize the covered person’s ability 6 to regain maximum function, the covered person or the covered 7 person’s authorized representative may file a request for an 8 expedited external review. 9 b. If the final adverse determination concerns an admission, 10 availability of care, continued stay, or health care service 11 for which the covered person received emergency services, but 12 has not been discharged from a facility, the covered person or 13 the covered person’s authorized representative may request an 14 expedited external review. 15 c. If the final adverse determination concerns a denial 16 of coverage based on a determination that the recommended or 17 requested health care service or treatment is experimental 18 or investigational as provided in section 514J.109, the 19 covered person may file a request for external review pursuant 20 to section 514J.109. In addition, if the covered person’s 21 treating health care professional certifies in writing that 22 the recommended or requested health care service or treatment 23 that is the subject of the recommendation or request would 24 be significantly less effective if not promptly initiated, 25 the covered person or the covered person’s authorized 26 representative may request an expedited external review 27 pursuant to section 514J.109, subsection 18. 28 4. The health carrier shall include with the notice a copy 29 of the descriptions of both the standard and expedited external 30 review procedures the health carrier is required to provide 31 pursuant to section 514J.116, highlighting the provisions in 32 the external review procedures that give the covered person or 33 the covered person’s authorized representative the opportunity 34 to submit additional information and including any forms used 35 -8- HF 597 (3) 84 av/nh/mb 8/ 41

H.F. 597 to process an external review. 1 5. The health carrier shall also include with the notice 2 an authorization form, or other document approved by the 3 commissioner that complies with the requirements of 45 C.F.R. 4 § 164.508 and with Tit. I of the federal Genetic Information 5 Nondiscrimination Act of 2008, Pub. L. No. 110-233, 122 Stat. 6 881, by which the covered person or the covered person’s 7 authorized representative authorizes the health carrier and 8 the covered person’s treating health care provider to disclose 9 protected health information, including medical records, 10 concerning the covered person that is pertinent to the external 11 review. 12 Sec. 5. NEW SECTION . 514J.105 Request for external review. 13 A covered person or the covered person’s authorized 14 representative may make a request for an external review of 15 a final adverse determination. Except for a request for an 16 expedited external review, all requests for external review 17 shall be made in writing to the commissioner. The commissioner 18 may prescribe by rule the form and content of external review 19 requests. 20 Sec. 6. NEW SECTION . 514J.106 Exhaustion of internal 21 grievance process —— exceptions —— expedited external review 22 request. 23 1. Except as otherwise provided in this section, a request 24 for an external review shall not be made until the covered 25 person or the covered person’s authorized representative has 26 exhausted the health carrier’s internal grievance process and 27 received a final adverse determination. 28 2. A covered person or the covered person’s authorized 29 representative shall be considered to have exhausted the health 30 carrier’s internal grievance process if the covered person or 31 the covered person’s authorized representative has filed a 32 grievance involving an adverse determination and, except to the 33 extent the covered person or the covered person’s authorized 34 representative requested or agreed to a delay, has not received 35 -9- HF 597 (3) 84 av/nh/mb 9/ 41

H.F. 597 a written decision on the grievance from the health carrier 1 within thirty days following the date the covered person or the 2 covered person’s authorized representative filed the grievance 3 with the health carrier. 4 3. A covered person or the covered person’s authorized 5 representative may file a request for an expedited external 6 review of an adverse determination without exhausting the 7 health carrier’s internal grievance process under either of the 8 following circumstances: 9 a. The covered person has a medical condition pursuant 10 to which the time frame for completion of an internal review 11 of the grievance involving an adverse determination would 12 seriously jeopardize the life or health of the covered person 13 or would jeopardize the covered person’s ability to regain 14 maximum function as provided in section 514J.108. 15 b. The adverse determination involves a denial of 16 coverage based on a determination that the recommended or 17 requested health care service or treatment is experimental or 18 investigational and the covered person’s treating physician 19 certifies in writing that the recommended or requested health 20 care service or treatment that is the subject of the adverse 21 determination would be significantly less effective if not 22 promptly initiated as provided in section 514J.109. 23 4. A request for an external review of an adverse 24 determination may be made before the covered person or the 25 covered person’s authorized representative has exhausted the 26 health carrier’s internal grievance procedures whenever the 27 health carrier agrees to waive the exhaustion requirement. 28 If the requirement to exhaust the health carrier’s internal 29 grievance procedures is waived, the covered person or the 30 covered person’s authorized representative may file a request 31 with the commissioner in writing for a standard external 32 review. 33 Sec. 7. NEW SECTION . 514J.107 External review —— standard. 34 1. A covered person or the covered person’s authorized 35 -10- HF 597 (3) 84 av/nh/mb 10/ 41

H.F. 597 representative may file a written request for an external 1 review with the commissioner within four months after any of 2 the following events: 3 a. The date of receipt of a final adverse determination. 4 b. The failure of a health carrier to issue a written 5 decision within thirty days following the date the covered 6 person or the covered person’s authorized representative filed 7 a grievance involving an adverse determination as provided in 8 section 514J.106, subsection 2. 9 c. The agreement of the health carrier to waive the 10 requirement that the covered person or the covered person’s 11 authorized representative exhaust the health carrier’s internal 12 grievance procedures before filing a request for external 13 review of an adverse determination as provided in section 14 514J.106, subsection 4. 15 2. Within one business day after the date of receipt of a 16 request for external review, the commissioner shall send a copy 17 of the request to the health carrier. 18 3. Within five business days following the date of receipt 19 of the external review request from the commissioner, the 20 health carrier shall complete a preliminary review of the 21 request to determine whether: 22 a. The individual is or was a covered person under the 23 health benefit plan at the time the health care service was 24 recommended or requested. 25 b. The health care service that is the subject of the 26 adverse determination or of the final adverse determination, 27 is a covered service under the covered person’s health benefit 28 plan, but for a determination by the health carrier that the 29 health care service is not covered because it does not meet 30 the health carrier’s requirements for medical necessity, 31 appropriateness, health care setting, level of care, or 32 effectiveness. 33 c. The covered person or the covered person’s authorized 34 representative has exhausted the health carrier’s internal 35 -11- HF 597 (3) 84 av/nh/mb 11/ 41

H.F. 597 grievance process, unless the covered person or the covered 1 person’s authorized representative is not required to exhaust 2 the health carrier’s internal grievance process pursuant to 3 section 514J.106 or this section. 4 d. The covered person or the covered person’s authorized 5 representative has provided all the information and forms 6 required to process an external review request. 7 4. Within one business day after completion of a preliminary 8 review pursuant to subsection 3, the health carrier shall 9 notify the commissioner and the covered person or the covered 10 person’s authorized representative in writing whether the 11 request is complete and whether the request is eligible for 12 external review. 13 a. If the health carrier determines that the request is not 14 complete, the health carrier shall notify the covered person 15 or the covered person’s authorized representative and the 16 commissioner in writing that the request is not complete and 17 what information or materials are needed to make the request 18 complete. 19 b. If the health carrier determines that the request is 20 not eligible for external review, the health carrier shall 21 issue a notice of initial determination in writing informing 22 the covered person or the covered person’s authorized 23 representative and the commissioner of that determination 24 and the reasons the request is not eligible for review. The 25 health carrier shall also include a statement in the notice 26 informing the covered person or the covered person’s authorized 27 representative that the health carrier’s initial determination 28 of ineligibility may be appealed to the commissioner. 29 5. The commissioner may specify by rule the form required 30 for the health carrier’s notice of initial determination and 31 any supporting information to be included in the notice. 32 6. The commissioner may determine that a request is eligible 33 for external review, notwithstanding a health carrier’s initial 34 determination that the request is not eligible, and refer the 35 -12- HF 597 (3) 84 av/nh/mb 12/ 41

H.F. 597 request for external review. In making this determination, the 1 commissioner’s decision shall be made in accordance with the 2 terms of the covered person’s health benefit plan and shall be 3 subject to all applicable provisions of this chapter. 4 7. Within one business day after receipt of notice from 5 a health carrier that a request for external review is 6 eligible for external review or upon a determination by the 7 commissioner that a request is eligible for external review, 8 the commissioner shall do all of the following: 9 a. Assign an independent review organization from the list 10 of approved independent review organizations maintained by the 11 commissioner and notify the health carrier of the name of the 12 assigned independent review organization. The assignment of 13 an independent review organization shall be done on a random 14 basis among those approved independent review organizations 15 qualified to conduct the particular external review based on 16 the nature of the health care service that is the subject of 17 the adverse determination or final adverse determination and 18 other circumstances, including conflict of interest concerns. 19 b. Notify the covered person or the covered person’s 20 authorized representative in writing that the request is 21 eligible and has been accepted for external review including 22 the name of the assigned independent review organization and 23 that the covered person or the covered person’s authorized 24 representative may submit in writing to the independent review 25 organization within five business days following receipt of 26 such notice from the commissioner, additional information 27 that the independent review organization shall consider 28 when conducting the external review. The independent review 29 organization may, in the organization’s discretion, accept and 30 consider additional information submitted by the covered person 31 or the covered person’s authorized representative after five 32 business days. 33 8. Within five business days after receipt of notice from 34 the commissioner pursuant to subsection 7, the health carrier 35 -13- HF 597 (3) 84 av/nh/mb 13/ 41

H.F. 597 shall provide to the independent review organization the 1 documents and any information considered in making the adverse 2 determination or final adverse determination. Failure by the 3 health carrier to provide the documents and information within 4 the time specified shall not delay the conduct of the external 5 review. 6 9. If the health carrier fails to provide the documents 7 and information within the time specified, the independent 8 review organization may terminate the external review and 9 make a decision to reverse the adverse determination or final 10 adverse determination. Within one business day after making 11 such a decision, the independent review organization shall 12 notify the covered person or the covered person’s authorized 13 representative, the health carrier, and the commissioner of its 14 decision. 15 10. The independent review organization shall review 16 all of the information and documents received pursuant to 17 subsection 8 and any other information submitted in writing 18 to the independent review organization by the covered person 19 or the covered person’s authorized representative pursuant to 20 subsection 7, paragraph “b” . Upon receipt of any information 21 submitted by the covered person or the covered person’s 22 authorized representative, the independent review organization 23 shall, within one business day, forward the information to the 24 health carrier. In reaching a decision the independent review 25 organization is not bound by any decisions or conclusions 26 reached during the health carrier’s internal grievance process. 27 11. Upon receipt of information forwarded pursuant to 28 subsection 10, a health carrier may reconsider its adverse 29 determination or final adverse determination that is the 30 subject of the external review. 31 a. Reconsideration by the health carrier of its 32 determination shall not delay or terminate the external review. 33 The external review shall only be terminated if the health 34 carrier decides, upon completion of its reconsideration, to 35 -14- HF 597 (3) 84 av/nh/mb 14/ 41

H.F. 597 reverse its determination and provide coverage or payment for 1 the health care service that is the subject of the adverse 2 determination or final adverse determination. 3 b. Within one business day after making a decision 4 to reverse its adverse determination or final adverse 5 determination, the health carrier shall notify the covered 6 person or the covered person’s authorized representative, 7 the independent review organization, and the commissioner in 8 writing of its decision. The independent review organization 9 shall terminate the external review upon receipt of notice 10 of the health carrier’s decision to reverse its adverse 11 determination or final adverse determination. 12 12. In addition to the documents and information provided to 13 the independent review organization pursuant to this section, 14 the independent review organization shall, to the extent the 15 information or documents are available and the independent 16 review organization considers them appropriate, consider the 17 following in reaching a decision: 18 a. The covered person’s pertinent medical records. 19 b. The treating health care professional’s recommendation. 20 c. Consulting reports from appropriate health care 21 professionals and other documents submitted by the health 22 carrier, covered person, or the covered person’s treating 23 physician or other health care professional. 24 d. The terms of coverage under the covered person’s health 25 benefit plan with the health carrier, to ensure that the 26 independent review organization’s decision is not contrary to 27 the terms of coverage under the covered person’s health benefit 28 plan with the health carrier. 29 e. The most appropriate practice guidelines, which shall 30 include applicable evidence-based standards and may include any 31 other practice guidelines developed by the federal government, 32 national or professional medical societies, boards, and 33 associations. 34 f. Any applicable clinical review criteria developed and 35 -15- HF 597 (3) 84 av/nh/mb 15/ 41

H.F. 597 used by the health carrier. 1 g. The opinion of the independent review organization’s 2 clinical reviewer after considering the information or 3 documents described in paragraphs “a” through “f” to the extent 4 the information or documents are available and the clinical 5 reviewer considers them relevant. 6 13. a. Within forty-five days after the date of receipt 7 of a request for an external review, the independent review 8 organization shall provide written notice of its decision to 9 uphold or reverse the adverse determination or final adverse 10 determination of the health carrier to the covered person or 11 the covered person’s authorized representative, the health 12 carrier, and the commissioner. 13 b. The independent review organization shall include in its 14 decision all of the following: 15 (1) A general description of the reason for the request for 16 external review. 17 (2) The date the independent review organization received 18 the assignment from the commissioner to conduct the external 19 review. 20 (3) The date the external review was conducted. 21 (4) The date of the decision. 22 (5) The principal reason or reasons for its decision, 23 including what applicable evidence-based standards, if any, 24 were a basis for its decision. 25 (6) The rationale for its decision. 26 (7) References to evidence or documentation, including 27 evidence-based standards, considered in reaching its decision. 28 14. Upon receipt of notice of a decision reversing the 29 adverse determination or final adverse determination of the 30 health carrier, the health carrier shall immediately approve 31 the coverage that was the subject of the determination. 32 Sec. 8. NEW SECTION . 514J.108 External review —— expedited. 33 1. Notwithstanding section 514J.107, a covered person or 34 the covered person’s authorized representative may make an 35 -16- HF 597 (3) 84 av/nh/mb 16/ 41

H.F. 597 oral or written request to the commissioner for an expedited 1 external review at the time the covered person or the covered 2 person’s authorized representative receives any of the 3 following: 4 a. An adverse determination that involves a medical 5 condition of the covered person for which the time frame for 6 completion of an internal review of a grievance involving an 7 adverse determination would seriously jeopardize the life or 8 health of the covered person or would jeopardize the covered 9 person’s ability to regain maximum function. 10 b. A final adverse determination that involves a medical 11 condition where the time frame for completion of a standard 12 external review would seriously jeopardize the life or health 13 of the covered person or would jeopardize the covered person’s 14 ability to regain maximum function. 15 c. A final adverse determination that concerns an admission, 16 availability of care, continued stay, or health care service 17 for which the covered person received emergency services, and 18 has not been discharged from a facility. 19 2. a. Upon receipt of a request for an expedited external 20 review, the commissioner shall immediately send written notice 21 of the request to the health carrier. 22 b. Immediately upon receipt of notice of a request for 23 expedited external review, the health carrier shall complete 24 a preliminary review of the request to determine whether the 25 request meets the eligibility requirements for external review 26 set forth in section 514J.107, subsection 3, and this section. 27 c. The health carrier shall then immediately issue a 28 notice of initial determination informing the commissioner 29 and the covered person or the covered person’s authorized 30 representative of its eligibility determination including 31 a statement informing the covered person or the covered 32 person’s authorized representative of the right to appeal that 33 determination to the commissioner. 34 d. The commissioner may specify by rule the form required 35 -17- HF 597 (3) 84 av/nh/mb 17/ 41

H.F. 597 for the health carrier’s notice of initial determination and 1 any supporting information to be included in the notice. 2 3. The commissioner may determine that a request is 3 eligible for expedited external review, notwithstanding a 4 health carrier’s initial determination that the request is 5 not eligible. In making a determination, the commissioner’s 6 decision shall be made in accordance with the terms of the 7 covered person’s health benefit plan and shall be subject to 8 all applicable provisions of this chapter. The commissioner 9 shall make a determination pursuant to this subsection as 10 expeditiously as possible. 11 4. a. Upon receipt of notice from a health carrier 12 that a request is eligible for expedited external review or 13 upon a determination by the commissioner that a request is 14 eligible for expedited external review, the commissioner shall 15 immediately assign an independent review organization from the 16 list of approved independent review organizations maintained by 17 the commissioner to conduct the expedited external review. The 18 commissioner shall then immediately notify the health carrier 19 and the covered person or the covered person’s authorized 20 representative of the name of the assigned independent review 21 organization. 22 b. The assignment of an independent review organization 23 shall be done on a random basis among those approved 24 independent review organizations qualified to conduct the 25 particular external review based on the nature of the health 26 care service that is the subject of the adverse determination 27 or final adverse determination and other circumstances, 28 including conflict of interest concerns. 29 5. Upon receiving notice of the independent review 30 organization assigned to conduct the expedited external review, 31 the health carrier shall provide or transmit all necessary 32 documents and information considered in making the adverse 33 determination or final adverse determination to the independent 34 review organization electronically or by telephone or facsimile 35 -18- HF 597 (3) 84 av/nh/mb 18/ 41

H.F. 597 or any other available expeditious method. 1 6. The independent review organization is not bound 2 by any decisions or conclusions reached during the health 3 carrier’s internal grievance process. The independent review 4 organization shall consider the documents and information 5 provided by the health carrier, and to the extent the 6 information or documents are available and the independent 7 review organization considers them appropriate, shall consider 8 the following in reaching a decision: 9 a. The covered person’s pertinent medical records. 10 b. The treating health care professional’s recommendation. 11 c. Consulting reports from appropriate health care 12 professionals and other documents submitted by the health 13 carrier, covered person or the covered person’s authorized 14 representative, or the covered person’s treating physician or 15 other health care professional. 16 d. The terms of coverage under the covered person’s health 17 benefit plan with the health carrier, to ensure that the 18 independent review organization’s decision is not contrary to 19 the terms of coverage under the covered person’s health benefit 20 plan with the health carrier. 21 e. The most appropriate practice guidelines, which shall 22 include applicable evidence-based standards and may include any 23 other practice guidelines developed by the federal government, 24 national or professional medical societies, boards, and 25 associations. 26 f. Any applicable clinical review criteria developed and 27 used by the health carrier. 28 g. The opinion of the independent review organization’s 29 clinical reviewer after considering the information or 30 documents described in paragraphs “a” through “f” to the extent 31 the information or documents are available and the clinical 32 reviewer considers them relevant. 33 7. a. As expeditiously as the covered person’s medical 34 condition or circumstances require, but in no event more than 35 -19- HF 597 (3) 84 av/nh/mb 19/ 41

H.F. 597 seventy-two hours after the date of receipt of an eligible 1 request for expedited external review, the assigned independent 2 review organization shall do all of the following: 3 (1) Make a decision to uphold or reverse the adverse 4 determination or final adverse determination of the health 5 carrier. 6 (2) Notify the covered person or the covered person’s 7 authorized representative, the health carrier, and the 8 commissioner of its decision. 9 b. If the notice given by the independent review 10 organization pursuant to paragraph “a” was not in writing, 11 within forty-eight hours after providing that notice, 12 the independent review organization shall provide written 13 confirmation of the decision to the covered person or the 14 covered person’s authorized representative, the health carrier, 15 and the commissioner that includes the information set forth in 16 section 514J.107, subsection 13, paragraph “b” . 17 c. Upon receipt of the notice of decision by an independent 18 review organization pursuant to paragraph “a” reversing the 19 adverse determination or final adverse determination, the 20 health carrier shall immediately approve the coverage that 21 was the subject of the adverse determination or final adverse 22 determination. 23 Sec. 9. NEW SECTION . 514J.109 External review of 24 experimental or investigational treatment adverse determinations. 25 1. Within four months after the date of receipt of a notice 26 of an adverse determination or final adverse determination that 27 involves a denial of coverage based on a determination that 28 the health care service or treatment recommended or requested 29 is experimental or investigational, a covered person or the 30 covered person’s authorized representative may file a request 31 for external review with the commissioner. 32 2. Within one business day after the date of receipt of the 33 request, the commissioner shall notify the health carrier of 34 the request. 35 -20- HF 597 (3) 84 av/nh/mb 20/ 41

H.F. 597 3. Within five business days following the date of receipt 1 of notice of a request for external review pursuant to this 2 section, the health carrier shall complete a preliminary review 3 of the request to determine whether: 4 a. The individual is or was a covered person under the 5 health benefit plan at the time the health care service or 6 treatment was recommended or requested. 7 b. The recommended or requested health care service or 8 treatment that is the subject of the adverse determination or 9 final adverse determination meets the following conditions: 10 (1) Is a covered benefit under the covered person’s health 11 benefit plan except for the health carrier’s determination that 12 the service or treatment is experimental or investigational for 13 a particular medical condition. 14 (2) Is not explicitly listed as an excluded benefit under 15 the covered person’s health benefit plan with the health 16 carrier. 17 c. The covered person’s treating physician has certified 18 that one of the following situations is applicable: 19 (1) Standard health care services or treatments have 20 not been effective in improving the condition of the covered 21 person. 22 (2) Standard health care services or treatments are not 23 medically appropriate for the covered person. 24 (3) There is no available standard health care service or 25 treatment covered by the health carrier that is more beneficial 26 than the recommended or requested health care service or 27 treatment sought. 28 d. The covered person’s treating physician has certified in 29 writing one of the following: 30 (1) That the recommended or requested health care service 31 or treatment that is the subject of the adverse determination 32 or final adverse determination is likely to be more beneficial 33 to the covered person, in the physician’s opinion, than any 34 available standard health care services or treatments. 35 -21- HF 597 (3) 84 av/nh/mb 21/ 41

H.F. 597 (2) The physician is a licensed, board-certified, or 1 board-eligible physician qualified to practice in the area of 2 medicine appropriate to treat the covered person’s condition, 3 and that scientifically valid studies using accepted protocols 4 demonstrate that the health care service or treatment 5 recommended or requested that is the subject of the adverse 6 determination or final adverse determination is likely to 7 be more beneficial to the covered person than any available 8 standard health care services or treatments. 9 e. The covered person or the covered person’s authorized 10 representative has exhausted the health carrier’s internal 11 grievance process, unless the covered person or the covered 12 person’s authorized representative is not required to exhaust 13 the health carrier’s internal grievance process pursuant to 14 section 514J.106 or 514J.108. 15 f. The covered person or the covered person’s authorized 16 representative has provided all the information and forms 17 required by the commissioner that are necessary to process an 18 external review pursuant to this section. 19 4. Within one business day after completion of the 20 preliminary review pursuant to subsection 3, the health 21 carrier shall notify the commissioner and the covered person 22 or the covered person’s authorized representative in writing 23 whether the request is complete and whether the request is 24 eligible for external review pursuant to this section. If the 25 request is not complete, the health carrier shall notify the 26 commissioner and the covered person or the covered person’s 27 authorized representative in writing and include in the notice 28 what information or materials are needed to make the request 29 complete. If the request is not eligible for external review, 30 the health carrier shall notify the covered person or the 31 covered person’s authorized representative and the commissioner 32 in writing and include in the notice the reasons for its 33 ineligibility. 34 5. The commissioner may specify by rule the form required 35 -22- HF 597 (3) 84 av/nh/mb 22/ 41

H.F. 597 for the health carrier’s notice of initial determination and 1 any supporting information to be included in the notice. The 2 notice of initial determination shall include a statement 3 informing the covered person or the covered person’s authorized 4 representative that a health carrier’s initial determination 5 that the external review request is ineligible for review may 6 be appealed to the commissioner. 7 6. The commissioner may determine that a request is eligible 8 for external review pursuant to this section, notwithstanding 9 a health carrier’s initial determination that the request 10 is ineligible, and require that it be referred for external 11 review. In making this determination, the commissioner’s 12 decision shall be made in accordance with the terms of the 13 covered person’s health benefit plan and shall be subject to 14 all applicable provisions of this chapter. 15 7. Within one business day after receipt of the notice 16 from the health carrier that the external review request is 17 eligible for external review or upon a determination by the 18 commissioner that a request is eligible for external review, 19 the commissioner shall do all of the following: 20 a. Assign an independent review organization from the list 21 of approved independent review organizations maintained by the 22 commissioner and notify the health carrier of the name of the 23 assigned independent review organization. 24 b. Notify the covered person or the covered person’s 25 authorized representative in writing of the request’s 26 eligibility and acceptance for external review and the 27 name of the assigned independent review organization and 28 that the covered person or the covered person’s authorized 29 representative may submit in writing to the independent review 30 organization, within five business days following the date 31 of receipt of such notice, additional information that the 32 independent review organization shall consider when conducting 33 the external review. The independent review organization 34 may, in the organization’s discretion, accept and consider 35 -23- HF 597 (3) 84 av/nh/mb 23/ 41

H.F. 597 additional information submitted by the covered person or the 1 covered person’s authorized representative after five business 2 days. 3 8. Within one business day after receipt of the notice 4 of assignment to conduct the external review, the assigned 5 independent review organization shall select one or more 6 clinical reviewers, as it determines is appropriate pursuant to 7 subsection 9 to conduct the external review. 8 9. In selecting clinical reviewers, the independent review 9 organization shall select physicians or other health care 10 professionals who meet the minimum qualifications described in 11 this chapter and, through clinical experience in the past three 12 years, are experts in the treatment of the covered person’s 13 condition and knowledgeable about the recommended or requested 14 health care service or treatment that is the subject of the 15 adverse determination or the final adverse determination. 16 Neither the covered person or the covered person’s authorized 17 representative nor the health carrier shall choose or control 18 the choice of the clinical reviewers selected to conduct the 19 external review. 20 10. Each clinical reviewer selected shall provide a written 21 opinion to the independent review organization regarding 22 whether the recommended or requested health care service or 23 treatment should be covered. Each clinical reviewer shall 24 review all of the information and documents received and any 25 other information submitted in writing by the covered person or 26 the covered person’s authorized representative. In reaching 27 an opinion, a clinical reviewer is not bound by any decisions 28 or conclusions reached during the health carrier’s internal 29 grievance process. 30 11. Within five business days after receipt of notice of the 31 assignment of the independent review organization, the health 32 carrier shall provide to the independent review organization 33 the documents and any information considered in making the 34 adverse determination or the final adverse determination. 35 -24- HF 597 (3) 84 av/nh/mb 24/ 41

H.F. 597 Failure by the health carrier to provide the documents and 1 information within the time specified shall not delay the 2 conduct of the external review. 3 12. If the health carrier fails to provide the documents 4 and information within the time specified, the independent 5 review organization may terminate the external review and 6 make a decision to reverse the adverse determination or final 7 adverse determination. Within one business day after making 8 such a decision, the independent review organization shall 9 notify the covered person or the covered person’s authorized 10 representative, the health carrier, and the commissioner. 11 13. Within one business day after the receipt of any 12 information submitted by the covered person or the covered 13 person’s authorized representative, the independent review 14 organization shall forward the information to the health 15 carrier. Upon receipt of the forwarded information, the health 16 carrier may reconsider its adverse determination or final 17 adverse determination that is the subject of the external 18 review. 19 a. Reconsideration by the health carrier of its adverse 20 determination or final adverse determination shall not delay or 21 terminate the external review. The external review shall only 22 be terminated if the health carrier decides, upon completion 23 of its reconsideration, to reverse its determination and 24 provide coverage or payment for the recommended or requested 25 health care service or treatment that is the subject of the 26 determination. 27 b. Within one business day after making a decision to 28 reverse its determination, the health carrier shall notify 29 the covered person or the covered person’s authorized 30 representative, the independent review organization, and the 31 commissioner in writing of its decision. The independent 32 review organization shall terminate the external review upon 33 receipt of such notice from the health carrier. 34 14. a. Within twenty days after being selected to conduct 35 -25- HF 597 (3) 84 av/nh/mb 25/ 41

H.F. 597 the external review, each clinical reviewer shall provide 1 an opinion to the assigned independent review organization 2 regarding whether the recommended or requested health care 3 service or treatment should be covered pursuant to this 4 section. 5 b. Each clinical reviewer’s opinion shall be in writing and 6 include the following information: 7 (1) A description of the covered person’s medical 8 condition. 9 (2) A description of the indicators relevant to determining 10 whether there is sufficient evidence to demonstrate that the 11 recommended or requested health care service or treatment is 12 likely to be more beneficial to the covered person than any 13 available standard health care services or treatments and that 14 the adverse risks of the recommended or requested health care 15 service or treatment would not be substantially increased over 16 those of available standard health care services or treatments. 17 (3) A description and analysis of any medical or scientific 18 evidence considered in reaching the opinion. 19 (4) A description and analysis of any applicable 20 evidence-based standards. 21 (5) Information on whether the reviewer’s rationale for 22 the opinion is based on either of the factors described in 23 subsection 15, paragraph “e” . 24 15. In addition to the documents and information provided, 25 each clinical reviewer, to the extent the information or 26 documents are available and the reviewer considers them 27 appropriate, shall consider all of the following in reaching 28 an opinion: 29 a. The covered person’s pertinent medical records. 30 b. The treating physician’s recommendation or request. 31 c. Consulting reports from appropriate health care 32 professionals and other documents submitted by the health 33 carrier, the covered person or the covered person’s authorized 34 representative, or the covered person’s treating physician or 35 -26- HF 597 (3) 84 av/nh/mb 26/ 41

H.F. 597 other health care professional. 1 d. The terms of coverage under the covered person’s health 2 benefit plan with the health carrier to ensure that, but 3 for the health carrier’s determination that the recommended 4 or requested health care service or treatment that is the 5 subject of the opinion is experimental or investigational, the 6 reviewer’s opinion is not contrary to the terms of coverage 7 under the covered person’s health benefit plan with the health 8 carrier. 9 e. Whether either of the following factors is applicable: 10 (1) The recommended or requested health care service or 11 treatment has been approved by the federal food and drug 12 administration, if applicable, for the condition. 13 (2) Medical or scientific evidence or evidence-based 14 standards demonstrate that the expected benefits of the 15 recommended or requested health care service or treatment is 16 likely to be more beneficial to the covered person than any 17 available standard health care service or treatment and the 18 adverse risks of the recommended or requested health care 19 service or treatment would not be substantially increased over 20 those of available standard health care services or treatments. 21 16. a. If a majority of the clinical reviewers opine that 22 the recommended or requested health care service or treatment 23 should be covered, the independent review organization shall 24 make a decision to reverse the health carrier’s adverse 25 determination or final adverse determination. 26 b. If a majority of the clinical reviewers opine that the 27 recommended or requested health care service or treatment 28 should not be covered, the independent review organization 29 shall make a decision to uphold the health carrier’s adverse 30 determination or final adverse determination. 31 c. If the clinical reviewers are evenly split as to whether 32 the recommended or requested health care service or treatment 33 should be covered, the independent review organization shall 34 obtain the opinion of an additional clinical reviewer in order 35 -27- HF 597 (3) 84 av/nh/mb 27/ 41

H.F. 597 for the independent review organization to make a decision 1 based on the opinions of a majority of the clinical reviewers. 2 d. The additional clinical reviewer selected shall use the 3 same information to reach an opinion as the clinical reviewers 4 who have already submitted their opinions. 5 e. The selection of an additional clinical reviewer under 6 this subsection shall not extend the time within which the 7 assigned independent review organization is required to make a 8 decision based on the opinions of the clinical reviewers for 9 the external review. 10 17. Within twenty days after it receives the opinion 11 of each clinical reviewer, the assigned independent review 12 organization shall make a decision based on the opinions of 13 the clinical reviewer or reviewers, to uphold or reverse the 14 adverse determination or final adverse determination of the 15 health carrier and provide written notice of the decision 16 to the covered person or the covered person’s authorized 17 representative, the health carrier, and the commissioner. 18 18. a. A covered person or the covered person’s authorized 19 representative may make a written or oral request to the 20 commissioner for an expedited external review of the adverse 21 determination or final adverse determination pursuant to 22 this subsection if the covered person’s treating physician 23 certifies, in writing, that the recommended or requested 24 health care service or treatment that is the subject of the 25 request would be significantly less effective if not promptly 26 initiated. 27 (1) Upon receipt of a request for an expedited external 28 review pursuant to this subsection, the commissioner shall 29 immediately notify the health carrier. 30 (2) Upon receipt of notice of the request for expedited 31 external review, the health carrier shall immediately determine 32 whether the request is eligible for external review as 33 provided in subsection 3, paragraphs “a” through “f” , and shall 34 immediately issue a notice of initial determination informing 35 -28- HF 597 (3) 84 av/nh/mb 28/ 41

H.F. 597 the commissioner and the covered person or the covered person’s 1 authorized representative of its eligibility determination. 2 The notice of initial determination of eligibility issued by a 3 health carrier shall include a statement informing the covered 4 person or the covered person’s authorized representative that 5 the health carrier’s initial determination that the external 6 review request is ineligible for expedited external review may 7 be appealed to the commissioner. 8 (3) The commissioner may determine that a request is 9 eligible for external review, notwithstanding a health 10 carrier’s initial determination that the request is not 11 eligible, and refer the request for external review. In making 12 this determination, the commissioner’s decision shall be made 13 in accordance with the terms of the covered person’s health 14 benefit plan and shall be subject to all applicable provisions 15 of this chapter. 16 b. (1) Upon receipt of the notice of initial determination 17 that the request is eligible for expedited external review 18 or upon a determination by the commissioner that the request 19 is eligible for expedited external review, the commissioner 20 shall immediately assign an independent review organization 21 to conduct the expedited external review, from the list of 22 approved independent review organizations maintained by the 23 commissioner, and notify the health carrier of the name of the 24 assigned independent review organization. 25 (2) Upon receipt of notice of the independent review 26 organization assigned to conduct an expedited external review, 27 the health carrier shall provide or transmit all necessary 28 documents and information considered in making the adverse 29 determination or final adverse determination to the independent 30 review organization electronically or by telephone or facsimile 31 or any other available expeditious method. 32 (3) A clinical reviewer or clinical reviewers shall be 33 selected immediately by the independent review organization and 34 shall provide an opinion orally or in writing to the assigned 35 -29- HF 597 (3) 84 av/nh/mb 29/ 41

H.F. 597 independent review organization as expeditiously as the covered 1 person’s medical condition or circumstances require, but in no 2 event more than five calendar days after being selected. If 3 the opinion provided was not in writing, within forty-eight 4 hours following the date the opinion was provided, the clinical 5 reviewer shall provide written confirmation of the opinion to 6 the assigned independent review organization and include all 7 required information in support of the opinion. 8 c. Within forty-eight hours after the date of receipt 9 of the opinion of each clinical reviewer, the assigned 10 independent review organization shall make a decision based 11 on the opinions of the clinical reviewer or reviewers as to 12 whether to reverse or uphold the adverse determination or 13 final adverse determination and provide notice of the decision 14 orally or in writing to the covered person or the covered 15 person’s authorized representative, the health carrier, and 16 the commissioner. If the notice was provided orally, within 17 forty-eight hours after the date of providing that notice, 18 the independent review organization shall provide written 19 confirmation of the decision to the covered person or the 20 covered person’s authorized representative, the health carrier, 21 and the commissioner. 22 d. The independent review organization shall include in the 23 notice of its decision all of the following: 24 (1) A general description of the reason for the request for 25 an expedited external review. 26 (2) The written opinion of each clinical reviewer, 27 including the recommendation of each clinical reviewer as 28 to whether the recommended or requested health care service 29 or treatment should be covered and the rationale for the 30 reviewer’s recommendation. 31 (3) The date the independent review organization was 32 assigned by the commissioner to conduct the expedited external 33 review. 34 (4) The date the expedited external review was conducted. 35 -30- HF 597 (3) 84 av/nh/mb 30/ 41

H.F. 597 (5) The date of its decision. 1 (6) The principal reason or reasons for its decision. 2 (7) The rationale for its decision. 3 19. Upon receipt of notice of a decision of the independent 4 review organization reversing an adverse determination or final 5 adverse determination, the health carrier shall immediately 6 approve coverage of the recommended or requested health care 7 service or treatment that was the subject of the determination. 8 Sec. 10. NEW SECTION . 514J.110 Effect of external review 9 decision. 10 1. An external review decision pursuant to this chapter is 11 binding on the health carrier except to the extent the health 12 carrier has other remedies available under applicable Iowa law. 13 The external review process shall not be considered a contested 14 case under chapter 17A. 15 2. a. A covered person or the covered person’s authorized 16 representative may appeal the external review decision made by 17 an independent review organization by filing a petition for 18 judicial review either in Polk county district court or in 19 the district court in the county in which the covered person 20 resides. The petition for judicial review must be filed 21 within fifteen business days after the issuance of the review 22 decision. The petition shall name the covered person or the 23 covered person’s authorized representative, or the person’s 24 health care provider as the petitioner. The respondent 25 shall be the health carrier. The petition shall not name the 26 independent review organization as a party. 27 b. The commissioner shall not be named as a respondent 28 unless the petitioner alleges action or inaction by the 29 commissioner under the standards articulated in section 30 17A.19, subsection 10. Allegations against the commissioner 31 under section 17A.19, subsection 10, shall be stated with 32 particularity. The commissioner may, upon motion, intervene in 33 the judicial review proceeding. The findings of fact by the 34 independent review organization conducting the external review 35 -31- HF 597 (3) 84 av/nh/mb 31/ 41

H.F. 597 are conclusive and binding on appeal. 1 3. The health carrier shall follow and comply with the 2 decision of the court on appeal. The health carrier or 3 treating health care provider shall not be subject to any 4 penalties, sanctions, or award of damages for following and 5 complying in good faith with the external review decision of 6 the independent review organization or the decision of the 7 court on appeal. 8 4. The covered person or the covered person’s authorized 9 representative may bring an action in Polk county district 10 court or in the district court in the county in which the 11 covered person resides to enforce the external review decision 12 of the independent review organization or the decision of the 13 court on appeal. 14 5. A covered person or the covered person’s authorized 15 representative shall not file a subsequent request for external 16 review involving any determination for which the covered person 17 or the covered person’s authorized representative has already 18 received an external review decision. 19 6. If a covered person dies before the completion of 20 the external review process, the process shall continue to 21 completion if there is potential liability of a health carrier 22 to the estate of the covered person. 23 7. a. If a covered person who has already received health 24 care services under a health benefit plan requests external 25 review of the plan’s adverse determination or final adverse 26 determination and changes to another health benefit plan before 27 the external review process is completed, the health carrier 28 whose coverage was in effect at the time the health care 29 service was received is responsible for completing the external 30 review process. 31 b. If a covered person who has not yet received health 32 care services requests external review of a health benefit 33 plan’s adverse determination or final adverse determination 34 and then changes to another plan prior to receipt of the 35 -32- HF 597 (3) 84 av/nh/mb 32/ 41

H.F. 597 health care services and completion of the external review 1 process, the external review process shall begin anew with the 2 covered person’s current health carrier. In this instance, 3 the external review process shall be conducted as an expedited 4 external review. 5 Sec. 11. NEW SECTION . 514J.111 Approval of independent 6 review organizations. 7 1. The commissioner shall approve applications submitted by 8 independent review organizations to conduct external reviews 9 under this chapter. The commissioner may retain an outside 10 expert to perform reviews of such applications. 11 2. In order to be eligible for approval by the commissioner 12 to conduct external reviews, an independent review organization 13 shall meet all of the following requirements: 14 a. Be accredited by a nationally recognized private 15 accrediting entity that the commissioner determines has 16 independent review organization accreditation standards that 17 are equivalent to or exceed the minimum qualifications for 18 independent review organizations established in this chapter. 19 b. Submit an application in a form and format as directed by 20 the commissioner. 21 c. Meet the minimum qualifications contained in section 22 514J.112. 23 3. The commissioner may approve independent review 24 organizations that are not accredited by a nationally 25 recognized private accrediting entity if there are no 26 acceptable nationally recognized private accrediting entities 27 providing independent review organization accreditation. 28 4. The commissioner shall develop an application form for 29 initially approving and for reapproving independent review 30 organizations to conduct external reviews. 31 5. The commissioner may charge an initial application fee 32 and a renewal fee as specified by rule. 33 6. The approval of an independent review organization to 34 conduct external reviews by the commissioner pursuant to this 35 -33- HF 597 (3) 84 av/nh/mb 33/ 41

H.F. 597 chapter is effective for two years, unless the commissioner 1 determines that the independent review organization is not 2 satisfying the minimum qualifications of this chapter. If the 3 commissioner determines that an independent review organization 4 has lost its accreditation or no longer satisfies the minimum 5 requirements established under this chapter, the commissioner 6 shall terminate approval of the independent review organization 7 to conduct external reviews and remove the independent review 8 organization from the list of independent review organizations 9 approved to conduct external reviews that is maintained by the 10 commissioner. 11 7. The commissioner shall maintain a list of currently 12 approved independent review organizations. 13 Sec. 12. NEW SECTION . 514J.112 Minimum qualifications for 14 independent review organizations. 15 1. To be approved to conduct external reviews pursuant 16 to this chapter, an independent review organization shall 17 have and maintain written policies and procedures that govern 18 all aspects of both the standard external review process and 19 the expedited external review process and that include, at a 20 minimum, all of the following: 21 a. A quality assurance mechanism that does all of the 22 following: 23 (1) Ensures that external reviews are conducted within the 24 specified time frames and that required notices are provided 25 in a timely manner. 26 (2) Ensures the selection of qualified and impartial 27 clinical reviewers to conduct external reviews on behalf of 28 the independent review organization and suitable matching of 29 reviewers to specific cases and that the independent review 30 organization employs or contracts with an adequate number of 31 clinical reviewers to meet this objective. 32 (3) Ensures the confidentiality of medical and treatment 33 records and clinical review criteria. 34 (4) Establishes and maintains written procedures to 35 -34- HF 597 (3) 84 av/nh/mb 34/ 41

H.F. 597 ensure that the independent review organization is unbiased in 1 addition to any other procedures required under this section. 2 (5) Ensures that any person employed by or under contract 3 with the independent review organization adheres to the 4 requirements of this chapter. 5 b. A toll-free telephone service to receive information 6 related to external reviews twenty-four hours a day, seven days 7 a week, that is capable of accepting, recording, or providing 8 appropriate instruction to incoming telephone callers outside 9 normal business hours. 10 c. An agreement and a system to maintain required records 11 and provide access to those records by the commissioner. 12 2. Each clinical reviewer assigned by an independent review 13 organization to conduct external reviews shall be a physician 14 or other appropriate health care professional who meets all of 15 the following minimum qualifications: 16 a. Is an expert in the treatment of the covered person’s 17 medical condition that is the subject of the external review. 18 b. Is knowledgeable about the recommended or requested 19 health care service or treatment through recent or current 20 actual clinical experience treating patients with the same or 21 similar medical condition as the covered person. 22 c. Holds a nonrestricted license in a state of the United 23 States and, for physicians, a current certification by a 24 recognized American medical specialty board in the area or 25 areas appropriate to the subject of the external review. 26 d. Has no history of disciplinary actions or sanctions, 27 including loss of staff privileges or participation 28 restrictions, that have been taken or are pending by any 29 hospital, governmental agency or unit, or regulatory body that 30 raise a substantial question as to the clinical reviewer’s 31 physical, mental, or professional competence or moral 32 character. 33 3. An independent review organization shall not own 34 or control, be a subsidiary of, or in any way be owned or 35 -35- HF 597 (3) 84 av/nh/mb 35/ 41

H.F. 597 controlled by, or exercise control with, a health benefit plan, 1 a national, state, or local trade association of health benefit 2 plans, or a national, state, or local trade association of 3 health care providers. 4 4. Neither the independent review organization selected to 5 conduct an external review nor any clinical reviewer assigned 6 by the independent organization to conduct an external review 7 shall have a material professional, familial, or financial 8 conflict of interest with any of the following: 9 a. The health carrier that is the subject of the external 10 review. 11 b. The covered person whose health care service or treatment 12 is the subject of the external review or the covered person’s 13 authorized representative. 14 c. Any officer, director, or management employee of the 15 health carrier that is the subject of the external review. 16 d. The health care professional or the health care 17 professional’s medical group or independent practice 18 association recommending the health care service or treatment 19 that is the subject of the external review. 20 e. The facility at which the recommended health care service 21 or treatment would be provided. 22 f. The developer or manufacturer of the principal drug, 23 device, procedure, or other therapy being recommended for the 24 covered person whose health care service treatment is the 25 subject of the external review. 26 5. In determining whether an independent review 27 organization or a clinical reviewer of the independent 28 review organization has a material professional, familial, 29 or financial conflict of interest as provided in subsection 30 4, the commissioner shall take into consideration situations 31 where the independent review organization to be assigned to 32 conduct an external review of a specified case or a clinical 33 reviewer to be assigned by the independent review organization 34 to conduct an external review of a specified case may have an 35 -36- HF 597 (3) 84 av/nh/mb 36/ 41

H.F. 597 apparent professional, familial, or financial relationship or 1 connection with a person described in subsection 4, but the 2 characteristics of that relationship or connection are such 3 that they do not constitute a material professional, familial, 4 or financial conflict of interest that would prohibit selection 5 of the independent review organization or the clinical reviewer 6 to conduct the external review. 7 6. a. An independent review organization that is accredited 8 by a nationally recognized private accrediting entity that 9 has independent review accreditation standards that the 10 commissioner has determined are equivalent to or exceed the 11 minimum qualifications of this section shall be presumed to be 12 in compliance with the requirements of this section. 13 b. The commissioner shall initially and periodically review 14 the standards of each nationally recognized private accrediting 15 entity that provides accreditation to independent review 16 organizations to determine whether the accrediting entity’s 17 standards are, and continue to be, equivalent to or exceed the 18 minimum qualifications established under this section. The 19 commissioner may accept a review of those standards conducted 20 by the national association of insurance commissioners for the 21 purpose of making a determination under this subsection. 22 c. Upon request, a nationally recognized private accrediting 23 entity shall make its current independent review organization 24 accreditation standards available to the commissioner or 25 to the national association of insurance commissioners in 26 order for the commissioner to determine if the accrediting 27 entity’s standards are equivalent to or exceed the minimum 28 qualifications established under this section. The 29 commissioner may exclude consideration of accreditation of 30 independent review organizations by any private accrediting 31 entity whose standards have not been reviewed by the national 32 association of insurance commissioners. 33 Sec. 13. NEW SECTION . 514J.113 Immunity for independent 34 review organizations. 35 -37- HF 597 (3) 84 av/nh/mb 37/ 41

H.F. 597 An independent review organization, a clinical reviewer 1 working on behalf of an independent review organization, or 2 an employee, agent, or contractor of an independent review 3 organization shall not be liable in damages to any person for 4 any opinions rendered or acts or omissions performed within the 5 scope of the duties of the organization, the clinical reviewer, 6 or an employee, agent, or contractor of the organization under 7 this chapter during, or upon completion of, an external review 8 conducted pursuant to this chapter, unless the opinion was 9 rendered or the act or omission was performed in bad faith or 10 involved gross negligence. 11 Sec. 14. NEW SECTION . 514J.114 External review reporting 12 requirements. 13 1. a. An independent review organization assigned to 14 conduct an external review shall maintain written records in 15 the aggregate by state and by health carrier of all requests 16 for external review for which it conducted an external review 17 during a calendar year. 18 b. Each independent review organization required to maintain 19 written records pursuant to this section shall submit to the 20 commissioner, upon request, a report in the format specified by 21 the commissioner. The report shall include in the aggregate by 22 state and by health carrier all of the following: 23 (1) The total number of requests for external review 24 assigned to the independent review organization. 25 (2) The average length of time for resolution of each 26 request for external review assigned to the independent review 27 organization. 28 (3) A summary of the types of coverages or cases for which 29 an external review was requested, in the format required by the 30 commissioner by rule. 31 (4) Any other information required by the commissioner. 32 c. The independent review organization shall retain the 33 written records for at least three years. 34 2. a. Each health carrier shall maintain written records 35 -38- HF 597 (3) 84 av/nh/mb 38/ 41

H.F. 597 in the aggregate by state and by type of health benefit plan 1 offered by the health carrier of all requests for external 2 review that the health carrier receives notice of from the 3 commissioner pursuant to this chapter. 4 b. Each health carrier required to maintain written records 5 of requests for external review pursuant to this subsection 6 shall submit to the commissioner, upon request, a report in the 7 format specified by the commissioner. The report shall include 8 in the aggregate by state and by type of health benefit plan 9 offered all of the following: 10 (1) The total number of requests for external review of 11 the health carrier’s adverse determinations and final adverse 12 determinations. 13 (2) Of the total number of requests for external review, the 14 number of requests determined eligible for external review. 15 (3) The number of requests for external review resolved 16 and, of those resolved, the number resolved upholding the 17 adverse determination or final adverse determination of the 18 health carrier and the number resolved reversing the adverse 19 determination or final adverse determination of the health 20 carrier. 21 (4) The number of external reviews that were terminated as 22 the result of a reconsideration by the health carrier of its 23 adverse determination or final adverse determination after the 24 receipt of additional information from the covered person or 25 the covered person’s authorized representative. 26 (5) Any other information the commissioner may request or 27 require. 28 c. The health carrier shall retain the written records for 29 at least three years. 30 Sec. 15. NEW SECTION . 514J.115 Expenses of external review. 31 The health carrier against which a request for a standard 32 external review or an expedited external review is filed shall 33 pay the costs of retaining an independent review organization 34 to conduct the external review. 35 -39- HF 597 (3) 84 av/nh/mb 39/ 41

H.F. 597 Sec. 16. NEW SECTION . 514J.116 Disclosure requirements. 1 1. Each health carrier shall include a description of 2 the external review procedures contained in this chapter in 3 or attached to any policy, certificate, membership booklet, 4 outline of coverage, or other evidence of coverage that is 5 provided to a covered person. The description shall be in a 6 format prescribed by the commissioner by rule. 7 2. The description required by subsection 1 shall include 8 a statement that informs the covered person of the right of 9 the covered person to file a request for an external review 10 of an adverse determination or final adverse determination of 11 the health carrier with the commissioner. The statement shall 12 explain that external review is available when the adverse 13 determination or final adverse determination involves an issue 14 of medical necessity, appropriateness, health care setting, 15 level of care, or effectiveness. The statement shall include 16 the telephone number and address of the commissioner. The 17 statement shall also inform the covered person that when filing 18 a request for external review, the covered person will be 19 required to authorize the release of any medical records of 20 the covered person that may be required to be reviewed for the 21 purpose of reaching a decision on the request for external 22 review. 23 Sec. 17. NEW SECTION . 514J.117 Rulemaking authority. 24 The commissioner may adopt rules pursuant to chapter 17A to 25 carry out the provisions of this chapter. 26 Sec. 18. NEW SECTION . 514J.118 Severability. 27 If any provision of this chapter, or the application of the 28 provision to any person or circumstance is held invalid, the 29 remainder of the chapter, and the application of the provision 30 to persons or circumstances other than those to which it is 31 held invalid, shall not be affected. 32 Sec. 19. NEW SECTION . 514J.119 Penalties. 33 A person who fails to comply with the provisions of this 34 chapter or the rules adopted pursuant to this chapter is 35 -40- HF 597 (3) 84 av/nh/mb 40/ 41

H.F. 597 subject to the penalties provided under chapter 507B. 1 Sec. 20. NEW SECTION . 514J.120 Applicability. 2 1. This chapter applies to all requests for external review 3 filed on or after July 1, 2011. 4 2. Section 514J.116 applies to all health benefit plans 5 delivered, issued for delivery, continued, or renewed in this 6 state on or after July 1, 2011. 7 Sec. 21. REPEAL. Sections 514J.1 through 514J.15, Code 8 2011, are repealed. 9 Sec. 22. TRANSITION PROVISION —— APPLICABILITY TO PRIOR 10 REQUESTS. Sections 514J.1 through 514J.15, Code 2011, are 11 applicable to all requests for external review filed prior to 12 July 1, 2011. 13 -41- HF 597 (3) 84 av/nh/mb 41/ 41