Effective Date of Rule: January 1, 2013.

     Purpose: These rules define the process used by the health care authority's (HCA) medical director to independently access 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.

     Statutory Authority for Adoption: RCW 7.70.060.

     Other Authority: ESHB 2318.

      Adopted under notice filed as WSR 12-21-109 on October 23, 2012.

     Changes Other than Editing from Proposed to Adopted Version: In response to stakeholders concern, the agency made the following changes to the final rule:

WAC 182-60-005 Authority and purpose.

     Under RCW 7.70.060(4), the agency's medical director is authorized to independently assess and certify patient decision aids based on the International Patient Decision Aid Standards.

WAC 182-60-010 Definitions.

     (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 or 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; or

     (b) Has been evaluated based on the International Patient Decision Aid Standards by an organization located in the United States and or 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 or Canada.

     (4) "National certifying organization" means a group, entity, or organization in the United States and or Canada that is recognized by the agency's medical director 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.

WAC 182-60-020 National certifying organizations.

     The agency's medical director will:

     (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.

WAC 182-60-025 Review process and certification.

     (2) A patient decision aid may be used certified 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.

     Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 5, Amended 0, Repealed 0.

     Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0;      Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 5, Amended 0, Repealed 0.

     Date Adopted: November 30, 2012.

Kevin M. Sullivan

Rules Coordinator

OTS-5083.4

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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 or 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; or

     (b) Has been evaluated based on the International Patient Decision Aid Standards (IPDAS) by an organization located in the United States or 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 or Canada.

     (4) "National certifying organization" means a group, entity, or organization in the United States or Canada that is recognized by the agency's medical director.

     (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.

     (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 certified 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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