W. Va. Code R. § 114-97-8

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

Section 114-97-8 - External Review of Experimental or Investigational Treatment Adverse Determinations

8.1. Within four months after the date of receipt of a notice of an adverse determination or final adverse determination that involves a denial of coverage based on a determination that the health care service or treatment recommended or requested is experimental or investigational, a covered person may file a request for external review with the Commissioner.

8.2. A covered person may make an oral request for an expedited external review of the adverse determination or final adverse determination pursuant to subsection 8.1 if the covered person's treating physician certifies, in writing, that the recommended or requested health care service or treatment that is the subject of the request would be significantly less effective if not promptly initiated. Such a request shall be handled in accordance with the procedure set forth in subsections 7.2 through and including 7.8.

8.3. Except for a request for expedited external review made pursuant to subsection 8.2, the Commissioner shall notify the issuer of any request made pursuant subsection 8.1 within one business day after the date of receipt of such request.

8.4. Within six business days following receipt of a copy of a covered person's external review request from the Commissioner pursuant to subsection 8.3, the issuer shall send the Commissioner and the covered person its determination whether the request is complete and if it is eligible for external review; such determination shall be based on consideration on the following:

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

8.4.b. The recommended or requested health care service or treatment that is the subject of the adverse determination or final adverse determination:

8.4.b.1. Is a covered benefit under the covered person's health benefit plan except for the issuer's determination that the service or treatment is experimental or investigational for a particular medical condition; and

8.4.b.2. Is not explicitly listed as an excluded benefit under the covered person's health benefit plan with the issuer;

8.4.c. The covered person's treating physician has certified that one of the following situations is applicable:

8.4.c.1. Standard health care services or treatments have not been effective in improving the condition of the covered person;

8.4.c.2. Standard health care services or treatments are not medically appropriate for the covered person; or

8.4.c.3. There is no available standard health care service or treatment covered by the issuer that is more beneficial than the recommended or requested health care service or treatment described in subdivision 8.4.d;

8.4.d. The covered person's treating physician:

8.4.d.1. Has recommended a health care service or treatment that the physician certifies, in writing, is likely to be more beneficial to the covered person, in the physician's opinion, than any available standard health care services or treatments; or

8.4.d.2. Who is licensed, board certified or board eligible physician qualified to practice in the area of medicine appropriate to treat the covered person's condition, has certified in writing that scientifically valid studies using accepted protocols demonstrate that the health care service or treatment requested by the covered person that is the subject of the adverse determination or final adverse determination is likely to be more beneficial to the covered person than any available standard health care services or treatments;

8.4.e. The covered person is deemed to have exhausted the issuer's internal grievance process as set forth in W.Va. Code of St. R. §114-95; and

8.4.f. The covered person has provided all the information and forms required by the Commissioner that are necessary to process an external review.

8.5. After the issuer has completed its review pursuant to subsection 8.4, the request for external review shall thereafter proceed according to the provisions of subsections 6.3 through and including 6.9.

8.5.a. Within one business day after the receipt of the notice of assignment to conduct the external review pursuant to subsection 8.5, the assigned IRO shall:

8.5.a.1. Select one or more clinical reviewers, as it determines is appropriate, pursuant to subdivision 8.5.b to conduct the external review; and

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

8.5.b. In selecting clinical reviewers pursuant to subdivision 8.5.a, the assigned IRO shall select physicians or other health care professionals who meet the minimum qualifications described in section 11 and, through clinical experience in the past three years, are experts in the treatment of the covered person's condition and knowledgeable about the recommended or requested health care service or treatment. Neither the covered person, the covered person's authorized representative, if applicable, nor the issuer shall choose or control the choice of the physicians or other health care professionals to be selected to conduct the external review.

8.5.c. In accordance with subsection 8.9, each clinical reviewer shall provide a written opinion to the assigned IRO on whether the recommended or requested health care service or treatment should be covered.

8.5.d. In reaching an opinion, clinical reviewers are not bound by any decisions or conclusions reached during the issuer's utilization review process as set forth in W.Va. Code of St. R. §114-95 or the issuer's internal grievance process as set forth W.Va. Code of St. R. §114-96.

8.6. Within five business days after the date of receipt of the notice provided pursuant to subdivision 8.5.a., the issuer or its designee utilization review organization shall provide to the assigned IRO the documents and any information considered in making the adverse determination or the final adverse determination.

8.6.a. Except as provided in subdivision 8.6.b, failure by the issuer or its designee utilization review organization to provide the documents and information within the time specified in subsection 8.6 may not delay the conduct of the external review.

8.6.b. If the issuer or its designee utilization review organization has failed to provide the documents and information within the time specified in subsection 8.6, the assigned IRO may terminate the external review and make a decision to reverse the adverse determination or final adverse determination. Immediately upon making the decision, the IRO shall notify the covered person, the issuer and the Commissioner.

8.7. Each clinical reviewer selected pursuant to subsection 8.5 shall review all of the information and documents received pursuant to subsection 8.6 and any other information submitted in writing by the covered person. Upon receipt of any information submitted by the covered person pursuant to subdivision 6.5.a and subsection 8.5, within one business day after the receipt of the information, the assigned IRO shall forward the information to the issuer.

8.8. Upon receipt of the information required to be forwarded pursuant to subsection 8.6, the issuer may reconsider its adverse determination or final adverse determination that is the subject of the external review. Reconsideration by the issuer of its adverse determination or final adverse determination of this subsection may not delay or terminate the external review.

8.8.a. The external review may be terminated only if the issuer decides, upon completion of its reconsideration, to reverse its adverse determination or final adverse determination and provide coverage or payment for the recommended or requested health care service or treatment that is the subject of the adverse determination or final adverse determination.

8.8.b. Immediately upon making the decision to reverse its adverse determination or final adverse determination, as provided in subdivision 8.8.a, the issuer shall notify the covered person, the assigned IRO, and the Commissioner in writing of its decision. The assigned IRO shall terminate the external review upon receipt of the notice from the issuer.

8.9. Except as provided in subdivision 8.9.b, within twenty days after being selected in accordance with subsection 8.5 to conduct the external review, each clinical reviewer shall provide an opinion to the assigned IRO pursuant to subsection 8.10 on whether the recommended or requested health care service or treatment should be covered.

8.9.a. Except for an opinion provided pursuant to subdivision 8.9.b, each clinical reviewer's opinion shall be in writing and include the following information:

8.9.a.1. A description of the covered person's medical condition;

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

8.9.a.3. A description and analysis of any medical or scientific evidence, as that term is defined in subsection 2.24.

8.9.a.4. A description and analysis of any evidence-based standard, as that term is defined in subsection 2.14.

8.9.a.5. Information on whether the reviewer's rational for the opinion is based on paragraphs 8.10.e.1 or 8.10.e.2.

8.9.b. For an expedited external review, each clinical reviewer shall provide an opinion orally or in writing to the assigned IRO as expeditiously as the covered person's medical condition or circumstances requires, but in no event more than five calendar days after being selected in accordance with subsection 8.5. If the opinion provided was not in writing, within forty-eight hours following the date the opinion was provided, the clinical reviewer shall provide written confirmation of the opinion to the assigned IRO and include the information required under subdivision 8.9.a.

8.10. In addition to the documents and information provided pursuant to subsection 8.2 or subsection 8.6, each clinical reviewer selected pursuant to subsection 8.5, to the extent the information or documents are available and the reviewer considers appropriate, shall consider the following in reaching an opinion pursuant to subsection 8.9:

8.10.a. The covered person's pertinent medical records;

8.10.b. The attending physician or health care professional's recommendation;

8.10.c. Consulting reports from appropriate health care professionals and other documents submitted by the issuer, covered person, the covered person's authorized representative, or the covered person's treating physician or health care professional;

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

8.10.e. Whether:

8.10.e.1. The recommended or requested health care service or treatment has been approved by the federal Food and Drug Administration, if applicable, for the condition; or

8.10.e.2. Medical or scientific evidence or evidence-based standards demonstrate that the expected benefits of the recommended or requested health care service or treatment is more likely than not to be beneficial to the covered person that any available standard health care service or treatment and the adverse risks of the recommended or requested health care service or treatment would not be substantially increased over those of available standard health care services or treatments.

8.11.Decisions.

8.11.a. Except as provided in 8.11.b, within twenty days after the date it receives the opinion of each clinical reviewer pursuant to subsection 8.9, the assigned IRO, in accordance with subdivision 8.11.d, shall make a decision and provide written notice of the decision to:

8.11.a.1. The covered person;

8.11.a.2. If applicable, the covered person's authorized representative;

8.11.a.3. The issuer; and

8.11.a.4. The Commissioner.

8.11.b. For an expedited external review, within forty-eight hours after the date it receives the opinion of each clinical reviewer pursuant to subsection 8.9, the assigned IRO, in accordance with subdivision 8.11 .d, shall make a decision and provide notice of the decision orally or in writing to the persons listed in subdivision 8.11.a.

8.11.c. If the notice provided under subdivision 8.11.b was not in writing, within forty-eight hours after the date of providing that notice, the assigned IRO shall provide written confirmation of the decision to the persons listed in subdivision 8.11.a and include the information set forth in subdivision 8.11.e.

8.11.d. If a majority of the clinical reviewers recommend that the recommended or requested health care service or treatment should be covered, the IRO shall make a decision to reverse the issuer's adverse determination or final adverse determination. If a majority of the clinical reviewers recommend that the recommended or requested health care service should not be covered , the IRO shall make a decision to uphold the issuer's adverse determination or final adverse determination.

8.11.d.1. If the clinical reviewers are evenly split as to whether the recommended or requested healthcare service or treatment should be covered, the IRO shall obtain the opinion of an additional clinical reviewer in order for the IRO to make a decision based on the opinions of a majority of the clinical reviewers pursuant to this subdivision.

8.11.d.2. The additional clinical reviewer selected under paragraph 8.11.d.1 shall use the same information to reach an opinion as the clinical reviewers who have already submitted their opinions pursuant to subsection 8.9.

8.11.d.3. The selection of the additional clinical reviewer under this paragraph shall not extend the time within which the assigned IRO is required to make a decision based on the opinions of the clinical reviewers selected under subsection 8.5.

8.11.e. The IRO shall include in the notice provided pursuant to subdivision 8.11.a:

8.11.e.1. A general description of the reason for the request for external review;

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

8.11.e.3. The date the IRO was assigned by the Commissioner to conduct the external review;

8.11.e.4. The date the external review was conducted;

8.11.e.5. The date of its decision;

8.11.e.6. The principal reason or reasons for its decision; and

8.11.e.7. The rationale for its decision.

8.11.f Upon receipt of a notice of a decision pursuant to subdivision 8.11.a reversing the adverse determination or final adverse determination, the issuer immediately shall approve coverage of the recommended or requested health care service or treatment that was the subject of the adverse determination or final adverse determination.

8.12. The assignment by the Commissioner of an approved IRO to conduct an external review in accordance with this section shall be done on a random basis among those approved IROs qualified to conduct the particular external review based on the nature of the health care service that is the subject of the adverse determination or final adverse determination and other circumstances, including conflict of interest concerns pursuant to subsection 11.4.

W. Va. Code R. § 114-97-8