Section 246-305-051. Additional requirements for experimental or investigational treatment reviews.

(1) In addition to the qualifications listed in WAC 246-305-040 (3) and (5), at least part of the clinical reviewers' relevant, recent clinical experience must have been obtained in the past three years.

(2) Each clinical reviewer shall consider the following information, if appropriate and available, in reaching an opinion:

(a) The enrollee's pertinent medical records;

(b) The attending physician or health care provider's recommendation;

(c) Consulting reports from appropriate health care providers and other documents submitted by the carrier, enrollee, or enrollee's authorized representative, or the enrollee's treating physician or health care provider; and

(d) Whether:

(i) The terms of coverage under the enrollee's health benefit plan would have covered the treatment had the carrier not determined that the treatment was experimental or investigational;

(ii) 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

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

(3) Clinical reviewers shall include the following in their written opinions to the IRO:

(a) A description of the enrollee's medical condition;

(b) 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 likely to be more beneficial to the enrollee than any available standard health care services or treatments and the adverse risks would not be substantially increased over those of available standard health care services or treatments;

(c) A description and analysis of any medical, scientific evidence, or cost-effectiveness evidence as defined in WAC 246-305-010(21);

(d) A description and analysis of any evidence-based standard as defined in WAC 246-305-010(12); and

(e) Information on whether the reviewer's rationale for the opinion is based on subsection (2)(e)(i) or (ii) of this section.

(4) IROs shall include the following in their notification of the results and rationale for the determination:

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

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

(c) The date the review was requested;

(d) The date the review was conducted;

(e) The date of the IRO's decision;

(f) The principle reason or reasons for the IRO's decision; and

(g) The rationale for the IRO's decision.

[Statutory Authority: RCW 43.70.235 and 48.43.535. WSR 11-23-124, § 246-305-051, filed 11/21/11, effective 11/26/11.]

RCW 43.70.235 and 48.43.535. WSR 11-23-124, § 246-305-051, filed 11/21/11, effective 11/26/11.

Rules

246-305-040,246-305-010,246-305-010,