Section 182-531-0550 - Experimental and investigational services(1) When the department makes a determination as to whether a proposed service is experimental or investigational, the department follows the procedures in this section. The policies and procedures and any criteria for making decisions are available upon request.(2) The determination of whether a service is experimental and/or investigational is subject to a case-by-case review under the provisions of WAC 388-501-0165 which relate to medical necessity. The department also considers the following: (a) Evidence in peer-reviewed medical literature, as defined in WAC 388-531-0050, and preclinical and clinical data reported to the National Institute of Health and/or the National Cancer Institute, concerning the probability of the service maintaining or significantly improving the enrollee's length or quality of life, or ability to function, and whether the benefits of the service or treatment are outweighed by the risks of death or serious complications;(b) Whether evidence indicates the service or treatment is more likely than not to be as beneficial as existing conventional treatment alternatives for the treatment of the condition in question;(c) Whether the service or treatment is generally used or generally accepted for treatment of the condition in the United States;(d) Whether the service or treatment is under continuing scientific testing and research;(e) Whether the service or treatment shows a demonstrable benefit for the condition;(f) Whether the service or treatment is safe and efficacious;(g) Whether the service or treatment will result in greater benefits for the condition than another generally available service; and(h) If approval is required by a regulating agency, such as the Food and Drug Administration, whether such approval has been given before the date of service.(3) The department applies consistently across clients with the same medical condition and health status, the criteria to determine whether a service is experimental. A service or treatment that is not experimental for one client with a particular medical condition is not determined to be experimental for another enrollee with the same medical condition and health status. A service that is experimental for one client with a particular medical condition is not necessarily experimental for another, and subsequent individual determinations must consider any new or additional evidence not considered in prior determinations.(4) The department does not determine a service or treatment to be experimental or investigational solely because it is under clinical investigation when there is sufficient evidence in peer-reviewed medical literature to draw conclusions, and the evidence indicates the service or treatment will probably be of greater overall benefit to the client in question than another generally available service.(5) All determinations that a proposed service or treatment is "experimental" or "investigation" are subject to the review and approval of a physician who is:(a) Licensed under chapter 18.57 RCW or an osteopath licensed under chapter 18.71 RCW;(b) Designated by the department's medical director to issue such approvals; and(c) Available to consult with the client's treating physician by telephone.Wash. Admin. Code § 182-531-0550
11-14-075, recodified as §182-531-0550, filed 6/30/11, effective 7/1/11. Statutory Authority: RCW 74.08.090. 10-19-057, § 388-531-0550, filed 9/14/10, effective 10/15/10. Statutory Authority: RCW 74.08.090, 74.09.520. 01-01-012, § 388-531-0550, filed 12/6/00, effective 1/6/01.