Preproposal statement of inquiry was filed as WSR 06-16-123.
Title of Rule and Other Identifying Information: WAC 182-55-005 Health technology assessment program.
Hearing Location(s): Health Care Authority (HCA), 676 Woodland Square Loop S.E., the Center Conference Room, Olympia, WA, on November 7, 2006, at 8:30 a.m.
Date of Intended Adoption: November 9, 2006.
Submit Written Comments to: Leah Hole-Curry, 676 Woodland Square Loop S.E., P.O. Box 42712, e-mail firstname.lastname@example.org, fax (360) 923-2766, by close of business on November 7, 2006.
Assistance for Persons with Disabilities: Contact Nikki Johnson by October 27, 2006, TTY (888) 923-5622 or (360) 923-2805.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The purpose of the proposed rule is to use a transparent and public process to implement new legislation. The proposed rules govern a new health technology assessment program that uses evidence to make coverage determinations for participating state purchased health care programs. The health technology assessment program (a) selects health technologies for assessment; (b) contracts with an evidence based practice center to produce health technology assessments; (c) establishes an independent health technology committee; and (d) maintains a centralized, internet based communication tool.
There are no existing rules related to this program.
Reasons Supporting Proposal: The 2006 legislature enacted E2SHB 2575 (chapter 307, Laws of 2006), creating new sections in chapter 70.14 RCW (RCW 70.14.080 - 70.14.140) and amending RCW 41.05.013. This legislation requires HCA to establish a new health technology assessment program and a health technology clinical committee. The agency must therefore adopt rules governing their operation.
Statutory Authority for Adoption: RCW 41.05.013, 41.05.160, and 70.14.090.
Statute Being Implemented: RCW 70.14.080 - 70.14.140.
Rule is not necessitated by federal law, federal or state court decision.
Name of Proponent: Health care authority, governmental.
Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Leah Hole-Curry, 676 Woodland Square Loop, Lacey, WA, (360) 923-2748.
No small business economic impact statement has been prepared under chapter 19.85 RCW. The joint administrative rules review committee has not requested the filing of a small business impact statement, and these rules set forth the internal processes that the health care authority will use to administer the health technology assessment program and the clinical committee. There are no requirements, or costs to comply with requirements imposed on businesses, including 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 4, 2006
Assistant Rules Coordinator
HEALTH TECHNOLOGY ASSESSMENT PROGRAM
(1) Selects health technologies for assessment;
(2) Contracts with an evidence-based practice center to produce health technology assessments;
(3) Establishes an independent health technology committee; and
(4) Maintains a centralized, internet based communication tool.
(1) "Administrator" means the administrator of the Washington state health care authority under chapter 41.05 RCW, as set forth in RCW 70.14.080, as amended.
(2) "Advisory group" means a group established under RCW 70.14.110 (2)(c).
(3) "Committee" means the health technology clinical committee established under RCW 70.14.090.
(4) "Coverage determination" means a determination of the circumstances, if any, under which a health technology will be included as a covered benefit in a state purchased health care program, as set forth in RCW 70.14.080, as amended.
(5) "Health technology" means medical and surgical devices and procedures, medical equipment, and diagnostic tests. Health technologies do not include prescription drugs governed by RCW 70.14.050.
(6) "Participating agency" means the department of social and health services, the state health care authority, and the department of labor and industries, as set forth in RCW 70.14.080, as amended.
(7) "Reimbursement determination" means a determination to provide or deny reimbursement for a health technology included as a covered benefit in a specific circumstance for an individual patient who is eligible to receive health care services from the state purchased health care program making the determination, as set forth in RCW 70.14.080, as amended.
(8) "Health technology assessment" means a report produced by a contracted evidence-based practice center as provided for in RCW 70.14.100(4) that is based on a systematic review of evidence of a technology's safety, efficacy, and cost-effectiveness.
(2) When appointing committee members, the administrator will consider, in addition to the membership requirements imposed by RCW 70.14.090 and any other relevant information, the following factors: Practitioner specialty or type and use of health technologies, especially in relation to current committee member specialty or types; practice location and community knowledge; length of practice experience; knowledge of and experience with evidence-based medicine, including formal additional training in fields relevant to evidence-based medicine; medical quality assurance experience; health technology assessment review experience.
(a) Shall not have a substantial financial conflict of interest, such as an interest in a health technology company, including the holding of stock options, or the receipt of honoraria, or consultant moneys;
(b) Must complete a conflict of interest disclosure form, update the form annually, and keep disclosure statements current;
(c) Must abide by confidentiality requirements and keep all personal medical information and proprietary information confidential; and
(d) Shall not utilize information gained as a result of committee membership outside of committee responsibilities, unless such information is publicly available. The administrator, in his/her sole discretion, may disqualify members if he/she determines that committee member has violated a condition of appointment.
(2) Committee members shall be appointed to a term of three years and shall serve until a successor is appointed. A member may be reappointed for additional three-year terms for a total of nine years. One year after the end of a nine-year term, a person is eligible for appointment to one additional three-year term. Committee members serve staggered three-year terms. Of the initial members, in order to provide for staggered terms, some members may be appointed initially for less than three years. If an initial appointment is for less than twenty-four months, that period of time shall not be counted toward the limitation of years of appointment. Vacancies on the committee will be filled for the balance of the unexpired term.
(3) The appointed committee chair shall select a vice-chair from among the committee membership; ratify committee bylaws approved by the administrator; and operate the committee according to the bylaws and committee member agreements.
(2) The committee shall give the greatest weight to the evidence determined, based on objective factors, to be the most valid and reliable, considering the nature and source of the evidence, the empirical characteristic of the studies or trials upon which the evidence is based, and the consistency of the outcome with comparable studies. The committee may also consider additional evidentiary valuation factors such as recency (date of information); relevance (the applicability of the information to the key questions presented or participating agency programs and clients); and bias (conflict of interest or political considerations).
(1) Determine the conditions, if any, under which the health technology will be included as a covered benefit in health care programs of participating agencies by deciding that:
(a) Coverage is allowed without special conditions because the evidence is sufficient to conclude that the health technology is safe, efficacious, and cost-effective for all populations; or
(b) Coverage is allowed with special conditions because the evidence is sufficient to conclude that the health technology is safe, efficacious, and cost-effective in only certain situations; or
(c) Coverage is not allowed because either the evidence is insufficient to conclude that the health technology is safe, efficacious, and cost-effective or the evidence is sufficient to conclude that the health technology is unsafe, ineffectual, or not cost-effective.
(2) Identify whether the determination is consistent with the identified Medicare decisions and expert guidelines.
(3) For decisions that are inconsistent with either the identified Medicare decisions or expert guidelines, specify the reason(s) for the decision and the evidentiary basis.
(4) For covered health technologies, specify criteria for participating agencies to use when deciding whether the health technology is medically necessary or proper and necessary treatment.
(2) Upon publication, participating agencies will implement the committee determination according to their statutory, regulatory, or contractual process unless:
(a) The determination conflicts with an applicable federal statute or regulation, or applicable state statute; or
(b) Reimbursement is provided under an agency policy regarding experimental or investigational treatment, services under a clinical investigation approved by an institutional review board, or health technologies that have a humanitarian device exemption from the federal food and drug administration.
(2) Advisory group membership: An ad hoc temporary advisory group shall include at least three members. Membership should reflect the diverse perspectives and/or technical expertise that drive the need for the specialized advisory group. The advisory group will generally include at least one enrollee, client, or patient; and two or more experts or specialists within the field relevant to the health technology, preferably with demonstrated experience in the use, evaluation, or research of the health technology. If substantial controversy over the health technology is present, at least one expert that is a proponent or advocate of the health technology and at least one expert that is an opponent or critic of the health technology should be appointed. A majority of each advisory group shall have no substantial financial interest in the health technology under review.
(3) As a continuing condition of appointment, advisory group members:
(a) Must complete an advisory group member agreement, including a conflict of interest disclosure form, and keep disclosure statements current;
(b) Must abide by confidentiality requirements and keep all personal medical information and proprietary information confidential; and
(c) Shall not utilize information gained as a result of advisory group membership outside of advisory group responsibilities, unless such information is publicly available.
(2) Interested parties that have submitted a petition for the review or rereview of a health technology that was not selected by the administrator may submit the petition to the committee for review or rereview.
(3) The committee may consider petitions submitted by interested parties for review or rereview of a health technology. The committee shall apply the priority criteria set forth in RCW 70.14.100.
(4) A health technology selected by the committee shall be referred to the administrator for the next available contract for health technology assessment review.
(2) Upon notice of the selection of the health technology for review, the administrator shall request participating agencies to provide information relevant to the health technology, including data on safety, health outcome, and cost. Such information shall be required to be submitted to the administrator, or designee, no earlier than thirty days from the date of the notice.
(3) Upon notice of the selection of the health technology for review, the administrator shall require staff to identify and organize relevant federal Medicare national coverage determinations and expert treatment guidelines, and any referenced information used as the basis for such determinations and/or guidelines.
(4) The administrator shall provide all information relevant to the selected health technology to the evidence-based practice center; and shall post such information, along with the key questions for review, on a centralized, internet based communication tool.
(5) Upon completion of the health technology assessment by the evidence-based practice center, the administrator shall provide the committee with:
(a) Final copy of the health technology assessment;
(b) Information as to whether the federal Medicare program has made a national coverage determination;
(c) A copy of identified national coverage decisions and accompanying information describing the basis for the decision;
(d) Information as to whether expert treatment guidelines exist, including those from specialty physician organizations and patient advocacy organizations; and
(e) A copy of identified guidelines and accompanying information describing the basis for the guidelines.