Section 10-16-113.5 - Independent external review of adverse determinations - legislative declaration - definitions - rules(1) The general assembly hereby finds, determines, and declares that, in the interest of improving accountability for health-care coverage decisions, individuals should have the option of an independent external review by qualified experts when there has been an adverse determination with respect to a health coverage plan pursuant to a carrier's procedures as required by section 10-16-113.(2) As used in this section, unless the context otherwise requires:(a) "Adverse determination" means a denial of:(I) A preauthorization for a covered benefit;(II) A request for benefits for an individual on the grounds that the treatment or covered benefit is not medically necessary, appropriate, effective, or efficient or is not provided in or at the appropriate health-care setting or level of care;(III) A request for benefits on the grounds that the treatment or services are experimental or investigational;(IV) A benefit as described in section 10-16-113 (1)(c); or(V) A request for benefits for a prescription drug that is unavailable in the state because a manufacturer has withdrawn the prescription drug from sale or distribution within the state under section 10-16-1412.(b) "Division" means the division of insurance in the department of regulatory agencies, established in section 10-1-103.(c) "Expedited review" means a review following completion of procedures for expedited internal review of an adverse determination involving a situation where the time frame of the standard independent external review procedures would seriously jeopardize the life or health of the individual or would jeopardize the individual's ability to regain maximum function. Expedited review is available if the adverse determination concerns an admission, availability of care, continued stay, or health-care services for which the individual received emergency services, and the individual has not been discharged from a facility.(d)(I) "Expert reviewer" means a physician or other appropriate health-care provider assigned by an independent external review entity to conduct an independent external review. An expert reviewer shall not: (A) Have been involved in the individual's care previously;(B) Be a member of the board of directors of the carrier;(C) Have been previously involved in the review process for the individual requesting an independent external review;(D) Have a direct financial interest in the case or in the outcome of the review; or(E) Be an employee of the carrier.(II) Physicians or other appropriate health-care providers who are expert reviewers must: (A) Be experts in the treatment of the medical condition of the individual requesting an independent external review and knowledgeable about the recommended treatment or service that is the subject of the review through the expert's actual, current clinical experience;(B) Hold a license issued by a state and, for physicians, a current certification by a recognized American medical specialty board in the area appropriate to the subject of review; and(C) Have no history of disciplinary action or sanction, including loss of staff privileges or participation restrictions, taken or pending by any hospital, government, or regulatory body.(e)(I) Except as specified in subparagraph (II) of this paragraph (e), "health coverage plan" has the same meaning as set forth in section 10-16-102 (34).(II) "Health coverage plan" does not include insurance arising out of the "Workers' Compensation Act of Colorado", articles 40 to 47 of title 8, C.R.S., or other similar law, automobile medical payment insurance, property and casualty insurance, or insurance under which benefits are payable with or without regard to fault and that is required by law to be contained in any liability insurance policy or equivalent self-insurance.(f) "Independent external review entity" means an entity that meets the requirements of this section, is accredited by a nationally recognized private accrediting organization, and is certified by the commissioner to conduct independent external reviews of adverse determinations by a carrier.(g)(I) "Individual requesting an independent external review" means a covered person who: (A) Has gone through at least one of the internal appeals review levels offered by a carrier and established pursuant to section 10-16-113 and has requested an independent external review of a carrier's decision to uphold an adverse determination; or(B) Has pursued an expedited review of an adverse determination.(II) "Individual requesting an independent external review" also includes the designated representative of an individual requesting an independent external review.(h) "Medical and scientific evidence" includes the following sources:(I) 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;(II) Peer-reviewed literature, biomedical compendia, and other medical literature that meet the criteria of the national institute of health's national library of medicine for indexing in index medicus, excerpta medicus ("EMBASE"), medline, and MEDLARS database of health services technology assessment research ("HSTAR");(III) Medical journals recognized by the United States secretary of health and human services, pursuant to section 1861 (t)(2) of the federal "Social Security Act", 42 U.S.C. sec. 1395x;(IV) The following standard reference compendia:(A) The American hospital formulary service-drug information;(B) The American medical association drug evaluation;(C) The American dental association accepted dental therapeutics; and(D) The United States pharmacopoeia - drug information.(V) Findings, studies, or research conducted by or under the auspices of federal government agencies and nationally recognized federal research institutes, including the federal agency for health care policy and research, national institutes of health, the national cancer institute, the national academy of sciences, the health care financing administration, the congressional office of technology assessment, and the national board recognized by the national institutes of health for the purpose of evaluating the medical value of health services.(3) Carriers shall make available an independent external review process that meets the requirements of this section. The carrier shall pay the cost of an independent external review. There is no restriction on the minimum dollar amount of a claim for it to be eligible for external review.(4)(a) To qualify for certification by the commissioner as an independent external review entity, the entity must meet the following requirements:(I) The independent external review entity shall ensure that cases are reviewed by expert reviewers knowledgeable about the recommended treatment or service through the expert reviewers' actual, current clinical experience and who have appropriate expertise in the same or similar specialties as would typically manage the case being reviewed.(II) The independent external review entity shall ensure that the decision is based upon a case review that includes a review of the medical records of the individual requesting an independent external review and a review of relevant medical and scientific evidence.(III) The independent external review entity shall have a quality assurance procedure that ensures the timeliness and quality of the reviews conducted pursuant to this section, the qualifications and independence of the expert reviewers, and the confidentiality of medical records and review materials.(IV) The independent external review entity shall maintain patient confidentiality pursuant to Colorado and federal law.(b) In addition to the requirements set forth in paragraph (a) of this subsection (4), the commissioner shall certify only an independent external review entity that: (I) Is not a subsidiary of, or owned or controlled by, a carrier, a trade association of carriers, or a professional association of health-care providers;(II) Maintains documentation available for review by the division upon request that includes the following: (A) The names of all stockholders and owners of more than five percent of stock or options;(B) The names of all holders of bonds or notes in amounts in excess of one hundred thousand dollars;(C) The names of all corporations and organizations that the independent external review entity controls or is affiliated with, and the nature and extent of any ownership or control, including the affiliated organization's business activities;(D) The names of all directors, officers, and executives of the independent external review entity and a statement regarding any relationship the directors, officers, or executives may have with any carrier;(III) Does not have any material professional, family, or financial conflict of interest with: (A) The carrier or any officer, director, or executive of the carrier. This requirement does not prohibit a physician or qualified health-care professional who contracts with the carrier as a participating provider from serving on a review panel of the independent external review entity if the physician or qualified health-care professional meets the requirements of paragraph (d) of subsection (2) of this section. If a participating provider serves on the panel reviewing the case of an individual requesting an independent external review, the review entity shall notify the individual requesting an independent external review that a health-care professional serving on the review panel has a contract as a participating provider with the carrier.(B) The physician or physician's medical group that treated the individual requesting an independent external review;(C) The institution at which the treatment or service would be provided;(D) The development or manufacture of the principal drug, device, procedure, treatment, or service proposed for the individual requesting an independent external review whose treatment is under review; or(E) The individual requesting an independent external review.(c) Nothing in subparagraph (III) of paragraph (b) of this subsection (4) includes affiliations that are limited to staff privileges at a health-care institution.(d) The commissioner shall promulgate rules as necessary for the certification of independent external review entities under this section. The commissioner may deny, suspend, or revoke the certification of an independent external review entity that does not comply with the requirements of this section. The commissioner may contract with any person or entity to develop the certification rules and for implementation and administration of the certification program.(5) Upon receipt of a request from an individual requesting an independent external review of a denial, the carrier shall contact the division. The division or its contractor shall inform the carrier of the name of the independent external review entity to which the appeal should be sent.(6) All health coverage plan materials dealing with the carrier's grievance procedures must advise individuals in writing of the availability of an independent external review process, the circumstances under which an individual requesting an independent external review may use the independent external review process, the procedures for requesting an independent external review, and the deadlines associated with an independent external review.(7) An individual requesting an independent external review shall make the request within four months after receiving notification of the denial of the individual's internal appeal of an adverse determination. In the internal appeal denial notification, the carrier shall inform the individual of his or her right to an independent external review. An individual requesting an independent external review shall notify the carrier if the individual requests an expedited review. An individual requesting an expedited independent external review may obtain such external review concurrently with an expedited internal appeal request under section 10-16-113.(8) An individual may request an independent external review or an expedited independent external review involving a denial of coverage of a recommended or requested medical service that is experimental or investigational if the individual's treating physician certifies in writing that the recommended or requested health-care service or treatment that is the subject of the denial would be significantly less effective if not promptly initiated. The individual's treating physician must certify in writing that at least one of the following situations applies: (a) Standard health-care services or treatments have not been effective in improving the condition of the individual or are not medically appropriate for the individual; or(b) There is no available standard health-care service or treatment covered by the carrier that is more beneficial than the recommended or requested health-care service, and the physician is a licensed, board-certified or board-eligible physician qualified to practice in the area of medicine appropriate to treat the individual's condition. The physician must certify that scientifically valid studies using accepted protocols demonstrate that the health-care service or treatment requested by the individual that is the subject of the denial is likely to be more beneficial to the individual than any available standard health-care services or treatments.(8.5) An individual requesting an independent external review may request the review or an expedited review to determine if section 10-16-704 (3) or (5.5) applies to the items or services that were provided or may be provided to a covered person by an out-of-network provider or at an out-of-network facility.(9) After receipt of a written request for an independent external review, the carrier shall notify the individual requesting an independent external review in writing. The notification must include descriptive information on the independent external review entity that the division or its contractor has selected to conduct the independent external review.(10)(a) The carrier shall provide to the independent external review entity a copy of the following documents after the division or its contractor has selected an independent external review entity for the case:(I) Any information submitted to the carrier, under the carrier's procedures, in support of the request for an independent external review, by an individual requesting the review or by the physician or other health-care professional of the individual seeking the review. The independent external review entity shall maintain the confidentiality of any medical records submitted pursuant to this subsection (10).(II) A copy of any relevant documents used by the carrier in making its adverse determination on the proposed service or treatment, and a copy of any denial letters issued by the carrier concerning the individual case under review. The carrier shall provide, upon request to the individual requesting an independent external review, all relevant information supplied to the independent external review entity that is not confidential or privileged under state or federal law concerning the individual case under review.(III) The individual requesting an independent external review may submit additional information directly to the independent external review entity within five business days after the notification under subsection (9) of this section. The independent external review entity shall provide a copy of the information submitted by the individual to the carrier whose adverse determination is being reviewed within one business day after receipt of the information.(b) The independent external review entity shall notify the individual requesting an independent external review, the physician or other health-care professional of the individual requesting an independent external review, and the carrier of any additional medical information required to conduct the review after receipt of the documentation required or provided pursuant to this subsection (10). The individual requesting an independent external review or the physician or other health-care professional of the individual requesting an independent external review shall submit the additional information, or an explanation of why the additional information is not being submitted, to the independent external review entity and the carrier after the receipt of such a request.(c) The carrier may determine that additional information provided by the individual requesting independent external review or the physician or other health-care professional of the individual requesting independent external review under subparagraph (III) of paragraph (a) and paragraph (b) of this subsection (10) justifies a reconsideration of its adverse determination, and a subsequent decision by the carrier to provide coverage terminates the independent external review upon notification in writing to the independent external review entity and the individual requesting an independent external review.(11)(a) The independent external review entity shall submit the expert determination to the carrier, the individual requesting independent external review, and the physician or other health-care professional of the individual requesting an independent external review within forty-five calendar days after the independent external review entity has received a request for external review. In the case of an expedited review, the independent external review entity shall submit the determinations as expeditiously as possible and no more than seventy-two hours after the independent external review entity received a request for an expedited external review. If the notice of the determination in an expedited review is not made in writing, the independent external review entity shall provide written confirmation of the decision within forty-eight hours after the date the notice of decision is transmitted to the individual, the physician, or other health-care professional.(b) The expert reviewer's determination must: (I) Be in writing and state the reasons the requested treatment or service should or should not be covered;(II) Specifically cite the relevant provisions in the health coverage plan documentation, the specific medical condition of the individual requesting an independent external review, and the relevant documents provided pursuant to this section to support the expert reviewer's determination; and(III) Be based on an objective review of relevant medical and scientific evidence.(c) Determinations must also include:(I) The titles and qualifying credentials of the persons conducting the review;(II) A statement of the understanding of the persons conducting the review of the nature of the grievance and all pertinent facts;(III) The rationale for the decision;(IV) Reference to medical and scientific evidence and documentation considered in making the determination; and(V) In cases involving a determination adverse to the individual requesting an independent external review, the instructions for requesting a written statement of the clinical rationale, including the clinical review criteria used to make the determination.(12) The determinations of the expert reviewer are binding on the carrier and on the individual requesting independent external review. A determination of the expert reviewer in favor of the individual requesting independent external review creates a rebuttable presumption in any subsequent action that the carrier's adverse determination was not appropriate. A determination of the expert reviewer in favor of the carrier creates a rebuttable presumption in any subsequent action that the carrier's adverse determination was appropriate.(13) Where an expert determination is made in favor of the individual requesting an independent external review, the carrier shall provide coverage for the treatment and services required under this section subject to the terms and conditions applicable to benefits under the health coverage plan.(14) An independent external review entity and an expert reviewer assigned by the independent external review entity to conduct a review pursuant to this section are immune from civil liability in any action brought by any person based upon the determinations made pursuant to this section. This subsection (14) does not apply to an act or omission of the independent external review entity that is made in bad faith or involves gross negligence.(15) A carrier is not liable for damages arising from any act or omission of the independent external review entity.(16) A carrier may require a surety bond to indemnify the carrier for the independent external review entity's noncompliance with this section.(17) An independent external review entity shall maintain written records of reviews on all requests for external review for which it was assigned to conduct an external review for at least three years.Amended by 2023 Ch. 162,§ 10, eff. 8/7/2023.Amended by 2022 Ch. 446, § 1, eff. 8/10/2022.Amended by 2016 Ch. 210, § 15, eff. 6/6/2016.Amended by 2013 Ch. 217, § 20, eff. 5/13/2013.L. 99: Entire section added, p. 1048, § 2, effective 6/1/2000. L. 2005: (2)(a)(I)(A) amended, p. 805, § 3, effective 1/1/2006. L. 2013: Entire section amended, (HB 13-1266), ch. 217, p. 961, § 20, effective May 13. L. 2016: (2)(f) amended, (SB 16-189), ch. 210, p. 756, § 15, effective June 6.2023 Ch. 162, was passed without a safety clause. See Colo. Const. art. V, § 1(3). 2022 Ch. 446, was passed without a safety clause. See Colo. Const. art. V, § 1(3).