BILL REQ. #:  Z-1045.2 

Read first time 01/10/2006.   Referred to Committee on Health & Long-Term Care.

     AN ACT Relating to establishing a state health technology assessment program; amending RCW 41.05.013; adding new sections to chapter 70.14 RCW; and creating a new section.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF WASHINGTON:

NEW SECTION.  Sec. 1   The legislature finds that a systematic assessment of the best available scientific and medical evidence and timely application of this evidence to informed coverage and medical necessity decisions by state purchased health care programs should result in improved access, prevention, and health outcomes for Washington citizens. Therefore, it is the intent of the legislature to support the establishment by the state of an evidence-based health technology assessment program that:
     (1) Conducts systematic reviews of scientific and medical literature to identify safe, efficacious, and cost-effective treatments;
     (2) Provides for the establishment of a statewide health technology clinical advisory committee;
     (3) Provides for the establishment of an evidence-based health technology assessment center;
     (4) Develops methods and processes to track health outcomes across state agencies; and
     (5) Provides clear and transparent access to the scientific basis of coverage decisions and treatment guidelines developed under this program.

NEW SECTION.  Sec. 2   A new section is added to chapter 70.14 RCW to read as follows:
     The definitions in this section apply throughout this chapter unless the context clearly requires otherwise.
     (1) "Best available scientific and medical evidence" means the best available external clinical evidence derived from systematic research.
     (2) "Coverage decision" means a determination regarding including or excluding a health technology as a covered benefit, and if covered, under what circumstances.
     (3) "Health technology" means a medical device, surgical and other procedures, medical equipment, diagnostic tests, and other health care services.
     (4) "Medical necessity decision" or "proper and necessary decision" means a determination whether or not to provide reimbursement for a covered health technology 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 decision.
     (5) "Treatment guideline" means an evidence-based set of explicit clinical recommendations for the appropriate application and use of a covered health technology for an individual circumstance, and developed or adopted by the health technology assessment program.

NEW SECTION.  Sec. 3   A new section is added to chapter 70.14 RCW to read as follows:
     (1) Each agency administering a state purchased health care program as defined in RCW 41.05.011(2) shall, in cooperation with other agencies, take action to prevent the application of health technologies where scientific and medical evidence suggests little or no benefit or possible harm, and to enhance the use of health technologies where evidence suggests substantial benefits. To accomplish this purpose, participating agencies may establish an evidence-based health technology assessment program. The provisions of the health technology assessment program do not apply to agency health technology decisions that have not been reviewed by the health technology clinical advisory committee and adopted by the agencies.
     (2) In developing the evidence-based health technology assessment program, agencies, to the extent permitted under federal and state law governing each agency:
     (a) Shall use the best available scientific and medical evidence to make coverage and medical necessity decisions and shall develop the resources necessary to collect and analyze the available scientific and medical evidence regarding a medical technology under review, including coordinating efforts with the evidence-based health technology assessment center in section 4 of this act;
     (b) Shall develop and implement uniform policies for a health technology assessment as provided in RCW 41.05.013, including development of common coverage decisions and treatment guidelines;
     (c) May develop treatment guidelines to assist in the appropriate application of medical necessity or proper and necessary decisions;
     (d) May develop criteria for payment of health technologies under reasonable exceptions, such as experimental or investigational treatment or services under a clinical investigation approved by an institutional review board;
     (e) May track and share safety, health outcome, and cost data related to use of health technologies to help inform health technology decisions;
     (f) For decisions related to the use of prescription drugs, shall develop policies and decisions consistent with RCW 70.14.050; and
     (g) Shall adopt rules as necessary to implement this section.
     (3) The agencies shall establish a health technology clinical advisory committee to make recommendations to the agencies regarding this act, including the development of treatment guidelines as appropriate.
     (4) The agencies may develop methods to report cost and outcome performance of the health technology assessment program.
     (5) The agencies shall develop a centralized, web-based communication tool that allows clear and transparent access to the scientific basis of coverage decisions and treatment guidelines developed under this program.
     (6) The standard of medical necessity or proper and necessary shall not apply to health technologies that are determined not to be covered based on the best available scientific evidence.
     (7) Appeals by persons or groups of an agency coverage decision or a medical necessity or proper and necessary decision must demonstrate that the decision is inconsistent with sound, evidence-based medical practice.

NEW SECTION.  Sec. 4   A new section is added to chapter 70.14 RCW to read as follows:
     (1) An evidence-based health technology assessment center is established to:
     (a) Conduct systematic reviews of the scientific literature regarding safety, efficacy, and cost-effectiveness; and
     (b) Assess the adequacy and quality of systematic reviews undertaken by other national or internationally recognized health technology assessment programs using systematic review methods substantially similar to those developed by the health technology assessment program.
     (2) Completed or received health technology assessments must be conducted in a timely manner and at the request of the health technology assessment program.
     (3) Requests for the conduct of a new health technology assessment must be proposed according to explicit prioritization criteria developed by the health technology assessment program.

NEW SECTION.  Sec. 5   A new section is added to chapter 70.14 RCW to read as follows:
     In the conduct of systematic scientific reviews by the evidence-based health technology assessment center, and in the conduct of business by the health technology clinical advisory committee, the health technology assessment program must ensure that conflicts of interest regarding a specific health technology be minimized and fully disclosed to the extent possible.

Sec. 6   RCW 41.05.013 and 2005 c 462 s 3 are each amended to read as follows:
     (1) The authority shall coordinate state agency efforts to develop and implement uniform policies across state purchased health care programs that will ensure prudent, cost-effective health services purchasing, maximize efficiencies in administration of state purchased health care programs, improve the quality of care provided through state purchased health care programs, and reduce administrative burdens on health care providers participating in state purchased health care programs. The policies adopted should be based, to the extent possible, upon the best available scientific and medical evidence and shall endeavor to address:
     (a) Methods of formal assessment, such as a health technology assessment under sections 2 through 5 of this act. Consideration of the best available scientific evidence does not preclude consideration of experimental or investigational treatment or services under a clinical investigation approved by an institutional review board;
     (b) Monitoring of health outcomes, adverse events, quality, and cost-effectiveness of health services;
     (c) Development of a common definition of medical necessity; and
     (d) Exploration of common strategies for disease management and demand management programs, including asthma, diabetes, heart disease, and similar common chronic diseases. Strategies to be explored include individual asthma management plans. On January 1, 2007, and January 1, 2009, the authority shall issue a status report to the legislature summarizing any results it attains in exploring and coordinating strategies for asthma, diabetes, heart disease, and other chronic diseases.
     (2) The administrator may invite health care provider organizations, carriers, other health care purchasers, and consumers to participate in efforts undertaken under this section.
     (3) For the purposes of this section "best available scientific and medical evidence" means the best available external clinical evidence derived from systematic research.