Original Notice.

     Preproposal statement of inquiry was filed as WSR 12-17-081.

     Title of Rule and Other Identifying Information: New chapter 182-60 WAC, Patient decision aids.

     Hearing Location(s): Health Care Authority (HCA), Cherry Street Plaza Building, Sue Crystal Conference Room A, 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 November 27, 2012, at 10:00 a.m.

     Date of Intended Adoption: Not sooner than November 28, 2012.

     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 November 27, 2012.

     Assistance for Persons with Disabilities: Contact Kelly Richters by November 19, 2012, 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: The proposed rules define the process used by the HCA's medical director to independently assess and certify patient decision aids. In addition, the proposed rules allow HCA to charge a fee to the certification applicant to defray the costs of the assessment and certification.

     Reasons Supporting Proposal: These rules are necessary to implement ESHB 2318 regarding shared decision making.

     Statutory Authority for Adoption: RCW 7.70.060, ESHB 2318.

     Statute Being Implemented: ESHB 2318.

     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 Boedigheimer, HCA, Legal and Administrative Services, (360) 725-1306; Implementation and Enforcement: Josiah Morse, HCA, Health Care Policy, (360) 725-0839.

     No small business economic impact statement has been prepared under chapter 19.85 RCW. The HCA has analyzed the proposed rules and concludes that 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.

October 23, 2012

Kevin M. Sullivan

Rules Coordinator

OTS-5083.2

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     (1) "Agency" means the Washington state health care authority (HCA), created pursuant to chapter 41.05 RCW.

     (2) "Certification fee" means a fee assessed by the agency to an individual or organization applicant requesting an independent review of a patient decision aid not already certified by an organization located in the United States and Canada and recognized by the agency's medical director.

     (3) "Certified patient decision aid" means a patient decision aid, as defined in this section, for any medical condition or procedure, including abortion as defined in RCW 9.02.170 that:

     (a) Is certified by one or more national certifying organizations recognized by the agency's medical director as using review criteria based on the International Patient Decision Aid Standards (IPDAS) developed by the IPDAS Collaboration;

     (b) Has been evaluated based on the International Patient Decision Aid Standards by an organization located in the United States and Canada and has current scores satisfactory to the agency's medical director in each of the following categories: Content criteria, development process criteria, and effectiveness criteria; or

     (c) Is independently assessed and certified by the agency's medical director based on the International Patient Decision Aid Standards developed by the IPDAS Collaboration if a current evaluation is not available from an organization located in the United States and Canada.

     (4) "National certifying organization" means a group, entity, or organization in the United States and Canada that uses the International Patient Decision Aid Standards developed by the IPDAS Collaboration to evaluate and certify patient decision aids, and that is determined, based on independent assessment of methods, reliability and validity by the agency's medical director, to meet the requirements in RCW 7.70.060.

     (5) "Patient decision aid" means a written, audio-visual, or on-line tool that provides a balanced presentation of the condition and treatment options, benefits, and harms including, if appropriate, a discussion of the limits of scientific knowledge about outcomes and a means to acknowledge that the tool has been fully reviewed and understood.

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     (1) Maintain a list of recognized national certifying organizations so that individuals or organizations seeking certification may identify organizations recognized by the agency's medical director as using the criteria of the International Patient Decision Aid Standards Collaboration and requiring a level of review of the validity and reliability of patient decision aids certified by the organization.

     (2) Consider organizations recommended by applicants for inclusion in the list.

     (3) Update the list as needed.

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     (2) A patient decision aid may be used if it is reviewed by a national certifying organization and has current scores satisfactory to the agency's medical director in each of the following categories: Content criteria, development process criteria, and effectiveness criteria.

     (3) The applicant requesting review and certification must provide written documentation of the basis for certification as provided in subsection (1) of this section.

     (4) The agency's medical director may contract for an assessment of the patient decision aid.

     (a) The contract will:

     (i) Be with an evidence-based organization or other appropriate entity; and

     (ii) Provide an assessment to evaluate the patient decision aid based on the most current International Patient Decision Aid Standards developed by the IPDAS Collaboration using information provided by the applicant and the agency's medical director.

     (b) The agency's medical director may use the results of the assessment in whole or part as the basis for a certification determination.

     (5) The agency's medical director may establish minimum scores in each of the following criteria: Content criteria, development process criteria, and effectiveness criteria, based on IPDAS Collaboration criteria, necessary to qualify as a certified patient decision aid.

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     (a) Fees will be based on the cost of obtaining an assessment.

     (b) One certification fee will apply to each review of a patient decision aid.

     (2) Applicants requesting review and certification of a patient decision aid must pay a fee established by the agency to defray the cost of review by a contracted review organization or group.

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