W. Va. Code R. § 114-58-5

Current through Register Vol. XLI, No. 50, December 13, 2024

Section 114-58-5 - Standard External Review

5.1. Within seven calendar days after receiving the written request for external review from the enrollee, a preliminary determination shall be completed by the commissioner to determine:

a. If the enrollee has provided all the information and forms necessary to process the external review request including, but not limited to, an authorization permitting disclosure of protected health information;

b. If the enrollee has received an adverse determination as defined in section 2 this rule;

c. If the adverse determination by the managed care plan would result in payment of at least one thousand dollars for health care services or a course of health care services if paid for by the enrollee;

d. If the individual is or was an enrollee in the plan at the time the health care service was requested, or in the case of a retrospective review, was an enrollee in the plan at the time the health care service was provided;

e. If the enrollee has exhausted all of the managed care plan's available internal grievance procedures; and

f. If the health care service that is the subject of the adverse determination reasonably appears to be a covered benefit under the plan. If the commissioner determines that the resolution of a medical issue is required for this determination, and if the request otherwise meets the requirements of this subsection, the commissioner shall certify the request for external review and proceed with assignment of an external review organization.

5.2. Within seven calendar days after receiving the written request for external review from the enrollee, the commissioner shall send to the enrollee and the managed care plan notification:

a. If the criteria for the preliminary determination set forth in subsection 5.1 have not been met, that the request is denied; or

b. If the criteria for the preliminary determination set forth in subsection 5.1 have been met and the request is complete, that the request has been certified for external review. If certified by the commissioner, the notice shall include the names, addresses, and telephone numbers of two randomly selected external review organizations which have been approved pursuant to section 8 and which do not have a conflict of interest as described in subdivision (d) of subsection 9.1 from which the managed care plan will choose one to conduct the external review. The managed care plan will notify the commissioner and the enrollee of its choice within two business days.

5.3. The notification required to be given by the commissioner under subsection 5.2 may be provided by telephone, facsimile, or electronic means followed by a written confirmation to the enrollee and the managed care plan within two business days.

5.4. If the commissioner cannot make the preliminary determination required by subsection 5.1 because the request for external review is incomplete, the notice shall so state and shall describe the information or materials needed to make the request complete.

5.5. The standard of review in an external review shall be whether the health care service denied by the managed care plan was medically necessary or experimental within the meaning of subsections 2.6 and 2.14 under the terms of the plan. In reaching a decision, the external review organization shall not be bound by any decisions or conclusions reached during the managed care plan's internal grievance procedure.

5.6. External review determinations are to be made by physician or provider panels.

a. External reviews concerning questions of medical necessity will be conducted by at least one physician, or other provider appropriate to the health care service under consideration, who is knowledgeable about the proposed health care service.

b. External reviews concerning whether a proposed health care service is experimental will be conducted by a panel of at least three physicians, or other providers appropriate to the health care service under consideration, who are knowledgeable about the proposed health care service.

c. External reviews concerning questions of both medical necessity and whether a proposed health care service is experimental will be conducted by a panel of at least three physicians, or other providers appropriate to the health care service under consideration, who are knowledgeable about the proposed health care service.

d. The opinion of a majority of the panel members is binding on the managed care plan with respect to that enrollee. If the opinions of the panel members are evenly divided, the decision shall be in favor of coverage. If less than a majority of the panel members recommends coverage, the managed care plan may, in its discretion, provide coverage, subject to the terms and conditions of the plan.

5.7. Within seven calendar days from the date the managed care plan receives notice from the commissioner that the request has been certified for external review, the managed care plan shall deliver to the assigned external review organization all documents and information in its possession that are relevant to the enrollee's medical condition and considered in making the managed care plan's adverse determination, including, but not limited to, the following:

a. All information used by the managed care plan during the internal grievance process to determine whether the proposed health care services were medically necessary or experimental, including medical and scientific evidence and clinical review criteria;

b. A copy of all denial letters issued by the managed care plan concerning the case under review;

c. A copy of the signed authorization permitting disclosure of protected health information; and

d. An index of all submitted documents.

5.8. Upon delivery of the required information and documentation to the external review organization, the managed care plan shall also provide to the commissioner written verification of its compliance with subsection 5.8.

5.9. The failure of the managed care plan to provide the information and documents set forth in subsection 5.8 within the stated time frame may result in the termination of the external review and a decision to reverse the adverse determination.

5.10. At the same time the information required by subsection 5.8 is delivered to the external review organization, the managed care plan shall also deliver to the enrollee a copy of the index of documents submitted. The enrollee or the enrollee's authorized representative may submit additional information to the external review organization within seven calendar days from the date the enrollee receives the index from the managed care plan. At the time any additional information is submitted by the enrollee to the external review organization, the enrollee shall also submit a copy of the information to the managed care plan.

5.11. The managed care plan, the enrollee, or the enrollee's health care provider shall provide any additional information the external review organization requests to complete the review. The additional information shall be provided within five calendar days of the request, which time may be extended upon written request to the commissioner, for good cause shown. The external review organization may make the request for additional information in writing, by telephone, by facsimile, or by electronic means followed by written confirmation of the request within five calendar days. If the requested additional information is not provided within the time specified, and the time is not extended by the commissioner, the external review organization shall proceed with its review without the information. The external review organization shall make record of its request for additional information and whether the additional information requested was received.

5.12. In making its decision, an external review organization shall consider safety, efficacy, appropriateness, and cost effectiveness. It shall take into account all of the information submitted by the managed care plan, the enrollee, and the enrollee's health care provider, including:

a. The enrollee's medical records;

b. The standards, criteria, and clinical rationale used by the managed care plan to make its decision;

c. The recommendation of the enrollee's health care provider;

d. Findings, studies, research, and other relevant documents of government agencies and nationally recognized medical professional organizations, including the National Institutes of Health or any board recognized by the National Institutes of Health, the National Cancer Institute, the National Academy of Sciences, the United States Food and Drug Administration, the Health Care Financing Administration of the United States Department of Health and Human Services, and the Agency for Health Care Policy Research and Quality;

e. Relevant findings in peer-reviewed medical or scientific literature, published opinions of nationally recognized medical experts, and clinical guidelines adopted by relevant national medical societies; and

f. The terms of coverage under the enrollee's managed care plan.

5.13. Nothing in this rule shall be construed to require the external review organization to utilize medical professionals or criteria in making decisions in external reviews regarding coverage for care by religious nonmedical providers.

5.14. As soon as possible, but not more than forty-five calendar days after the date the request for external review is assigned to the external review organization, unless extended by the commissioner for good cause shown, the assigned external review organization shall send written notice of its decision to uphold or reverse the managed care plan's adverse determination to:

a. The enrollee or the enrollee's authorized representative;

b. The managed care plan;

c. The commissioner; and

d. The enrollee's health care provider.

5.15. The notice sent pursuant to subsection 5.15 shall include the following information:

a. A general description of the reason for the request for external review;

b. The date the external review organization received the assignment from the commissioner to conduct the external review;

c. The date the external review was conducted;

d. The date of the external review organization's decision;

e. The reason(s) and clinical rationale for its decision, including, at a minimum, consideration of safety, efficacy, appropriateness, the managed care plan's terms of coverage, and cost effectiveness, with references to the evidence and documentation considered in reaching the decision; and

f. An explanation that the external review decision is binding on the enrollee and the managed care plan.

5.16. The managed care plan may elect at any time to cover the proposed health care service and request termination of the external review. The managed care plan shall notify the enrollee, the health care provider, the external review organization and the commissioner of its election to provide coverage. Upon receipt of the notice from the managed care plan, the external review organization shall terminate the external review.

5.17. If the external review organization reverses the adverse determination, the managed care plan shall provide coverage for the health care services that were the subject of the adverse determination.

5.18. An enrollee shall not be required to pay for any part of the cost of the review. All costs and fees associated with the external review shall be borne by the managed care plan.

W. Va. Code R. § 114-58-5