Original Notice.

     Preproposal statement of inquiry was filed as WSR 13-06-061.

     Title of Rule and Other Identifying Information: WAC 182-531-1600 Bariatric surgery.

     Hearing Location(s): Health Care Authority (HCA), Cherry Street Plaza Building, Conference Room, 626 8th Avenue, Olympia, WA 98504 (metered public parking is available street side around building. A map is available at http://maa.dshs.wa.gov/pdf/CherryStreetDirectionsNMap.pdf

or directions can be obtained by calling (360) 725-1000), on June 4, 2013, at 10:00 a.m.

     Date of Intended Adoption: Not sooner than June 5, 2013.

     Submit Written Comments to: HCA Rules Coordinator, P.O. Box 45504, Olympia, WA 98504-5504, delivery 626 8th Avenue, Olympia, WA 98504, e-mail arc@hca.wa.gov, fax (360) 586-9727, by 5:00 p.m. on June 4, 2013.

     Assistance for Persons with Disabilities: Contact Kelly Richters by May 28, 2013, TTY (800) 848-5429 or (360) 725-1307 or e-mail kelly.richters@hca.wa.gov.

     Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: Revision to this rule is necessary to add coverage for clients eighteen through twenty years of age for laparoscopic adjustable gastric banding (LAGB) when the criteria in WAC 182-531-1600 is met.

     Reasons Supporting Proposal: This policy change is based on the Health Technology Assessment Clinical Committee's Findings and Coverage Decision completed in 2007 (Pediatric Bariatric Surgery).

     Statutory Authority for Adoption: RCW 41.05.021, WAC 182-501-0055.

     Statute Being Implemented: RCW 41.05.021.

     Rule is not necessitated by federal law, federal or state court decision.

     Name of Proponent: HCA, governmental.

     Name of Agency Personnel Responsible for Drafting: Wendy L. Boedigheimer, Legal and Administrative Services, RPS, (360) 725-1306; Implementation and Enforcement: Jean Gowen, Health Services, Health Care Benefits, (360) 725-2005.

     No small business economic impact statement has been prepared under chapter 19.85 RCW. The agency has analyzed the proposed rules and concludes they do not impose more than minor costs for affected small businesses.

     A cost-benefit analysis is not required under RCW 34.05.328. RCW 34.05.328 does not apply to HCA rules unless requested by the joint administrative rules [review] committee or applied voluntarily.

April 29, 2013

Kevin M. Sullivan

Rules Coordinator

OTS-5360.1

AMENDATORY SECTION(Amending WSR 11-14-075, filed 6/30/11, effective 7/1/11)

WAC 182-531-1600   Bariatric surgery.   (1) The ((department)) agency covers medically necessary bariatric surgery for eligible clients.

     (2) Bariatric surgery must be performed in a hospital with a bariatric surgery program, and the hospital must be:

     (a) Located in the state of Washington or approved border cities (see WAC ((388-501-0175)) 182-501-0175); and

     (b) Meet the requirements of WAC ((388-550-2301)) 182-550-2301.

     (3) If bariatric surgery is requested or prescribed under the EPSDT program, the ((department)) agency evaluates it as a covered service under EPSDT's standard of coverage that requires the service to be:

     (a) Medically necessary;

     (b) Safe and effective; and

     (c) Not experimental.

     (4) The ((department)) agency authorizes payment for bariatric surgery and bariatric surgery-related services in three stages:

     (a) Stage one(( -- )) - Initial assessment of client;

     (b) Stage two(( -- )) - Evaluations for bariatric surgery and successful completion of a weight loss regimen; and

     (c) Stage three(( -- )) - Bariatric surgery.

     Stage one(( -- )) - Initial assessment

     (5) Any ((department-enrolled)) agency-enrolled provider who is licensed to practice medicine in the state of Washington may examine a client requesting bariatric surgery to ascertain if the client meets the criteria listed in subsection (6) of this section.

     (6) The client meets the preliminary conditions of stage one when:

     (a) The client is ((between)):

     (i) Twenty-one ((and)) through fifty-nine years of age; or

     (ii) Eighteen through twenty years old for laparoscopic adjustable gastric banding (LAGB) only;

     (b) The client has a body mass index (BMI) of thirty-five or greater;

     (c) The client is not pregnant. (Pregnancy within the first two years following bariatric surgery is not recommended. When applicable, a family planning consultation is highly recommended prior to bariatric surgery);

     (d) The client is diagnosed with one of the following:

     (i) Diabetes mellitus;

     (ii) Degenerative joint disease of a major weight bearing joint(s) (the client must be a candidate for joint replacement surgery if weight loss is achieved); or

     (iii) Other rare comorbid conditions (such as pseudo tumor cerebri) in which there is medical evidence that bariatric surgery is medically necessary and that the benefits of bariatric surgery outweigh the risk of surgical mortality; and

     (e) The client has an absence of other medical conditions such as multiple sclerosis (MS) that would increase the client's risk of surgical mortality or morbidity from bariatric surgery.

     (7) If a client meets the criteria in subsection (6) of this section, the provider must request prior authorization from the ((department)) agency before referring the client to stage two of the bariatric surgery authorization process. The provider must attach a medical report to the request for prior authorization with supporting documentation that the client meets the stage one criteria in subsections (5) and (6) of this section.

     (8) The ((department)) agency evaluates requests for covered services that are subject to limitations or other restrictions and approves such services beyond those limitations or restrictions when medically necessary, under the provisions of WAC ((388-501-0165)) 182-501-0165 and ((388-501-0169)) 182-501-0169.

     Stage two(( -- )) - Evaluations for bariatric surgery and successful completion of a weight loss regimen

     (9) After receiving prior authorization from the ((department)) agency to begin stage two of the bariatric surgery authorization process, the client must:

     (a) Undergo a comprehensive psychosocial evaluation performed by a psychiatrist, licensed psychiatric ARNP, or licensed independent social worker with a minimum of two years postmasters' experience in a mental health setting. Upon completion, the results of the evaluation must be forwarded to the ((department)) agency. The comprehensive psychosocial evaluation must include:

     (i) An assessment of the client's mental status or illness to:

     (A) Evaluate the client for the presence of substance abuse problems or psychiatric illness which would preclude the client from participating in presurgical dietary requirements or postsurgical lifestyle changes; and

     (B) If applicable, document that the client has been successfully treated for psychiatric illness and has been stabilized for at least six months and/or has been rehabilitated and is free from any drug and/or alcohol abuse and has been drug and/or alcohol free for a period of at least one year.

     (ii) An assessment and certification of the client's ability to comply with the postoperative requirements such as lifelong required dietary changes and regular follow-up.

     (b) Undergo an internal medicine evaluation performed by an internist to assess the client's preoperative condition and mortality risk. Upon completion, the internist must forward the results of the evaluation to the ((department)) agency.

     (c) Undergo a surgical evaluation by the surgeon who will perform the bariatric surgery (see subsection (13) of this section for surgeon requirements). Upon completion, the surgeon must forward the results of the surgical evaluation to the ((department)) agency and to the licensed medical provider who is supervising the client's weight loss regimen (refer to WAC ((388-531-1600)) 182-531-1600 (9)(d)(ii)).

     (d) Under the supervision of a licensed medical provider, the client must participate in a weight loss regimen prior to surgery. The client must, within one hundred and eighty days from the date of the ((department's)) agency's stage one authorization, lose at least five percent of his or her initial body weight. If the client does not meet this weight loss requirement within one hundred and eighty days from the date of the ((department's)) agency's initial authorization, the ((department)) agency will cancel the authorization. The client or the client's provider must reapply for prior authorization from the ((department)) agency to restart stage two. For the purpose of this section, "initial body weight" means the client's weight at the first evaluation appointment.

     (i) The purpose of the weight loss regimen is to help the client achieve the required five percent loss of initial body weight prior to surgery and to demonstrate the client's ability to adhere to the radical and lifelong behavior changes and strict diet that are required after bariatric surgery.

     (ii) The weight loss regimen must:

     (A) Be supervised by a licensed medical provider who has a core provider agreement with the ((department)) agency;

     (B) Include monthly visits to the medical provider;

     (C) Include counseling twice a month by a registered dietician referred to by the treating provider or surgeon; and

     (D) Be at least six months in duration.

     (iii) Documentation of the following requirements must be retained in the client's medical file. Copies of the documentation must be forwarded to the ((department)) agency upon completion of stage two. The ((department)) agency will evaluate the documentation and authorize the client for bariatric surgery if the stage two requirements were successfully completed.

     (A) The provider must document the client's compliance in keeping scheduled appointments and the client's progress toward weight loss by serial weight recordings. The client((s)) must lose at least five percent ((loss)) of his or her initial body weight and must maintain the five percent weight loss until surgery;

     (B) For diabetic clients, the provider must document the efforts in diabetic control or stabilization;

     (C) The registered dietician must document the client's compliance (or noncompliance) in keeping scheduled appointments, and the client's weight loss progress;

     (D) The client must keep a journal of active participation in the medically structured weight loss regimen including the activities under (d)(iii)(A), (d)(iii)(B) if appropriate, and (d)(iii)(C) of this subsection.

     (10) If the client fails to complete all of the requirements of subsection (9) of this section, the ((department)) agency will not authorize stage three(( -- )) - Bariatric surgery.

     (11) If the client is unable to meet all of the stage two criteria, the client or the client's provider must reapply for prior authorization from the ((department)) agency to reenter stage two.

     Stage three(( -- )) - Bariatric surgery

     (12) The ((department)) agency may withdraw authorization of payment for bariatric surgery at any time up to the actual surgery if the ((department)) agency determines that the client is not complying with the requirements of this section.

     (13) A surgeon who performs bariatric surgery for medical assistance clients must:

     (a) Have a signed core provider agreement with the ((department)) agency;

     (b) Have a valid medical license in the state of Washington; and

     (c) Be affiliated with a bariatric surgery program that meets the requirements of WAC ((388-550-2301)) 182-550-2301.

     (14) For hospital requirements for stage three(( -- )) - Bariatric surgery, see WAC ((388-530-2301)) 182-550-2301.

[11-14-075, recodified as § 182-531-1600, filed 6/30/11, effective 7/1/11. Statutory Authority: RCW 74.04.050, 74.08.090, 74.09.530, and 74.09.700. 06-24-036, § 388-531-1600, filed 11/30/06, effective 1/1/07. Statutory Authority: RCW 74.08.090, 74.09.520. 05-12-022, § 388-531-1600, filed 5/20/05, effective 6/20/05; 01-01-012, § 388-531-1600, filed 12/6/00, effective 1/6/01.]