Participants in clinical trials
(1) As used in this section:
(a) “Approved clinical trial” has the meaning given that term in ORS 743A.192 (Clinical trials).
(b) “Routine health care”:
(A) Means the types and extent of health care and services that the Oregon Health Authority requires to be provided in medical assistance in accordance with ORS 414.065 (Determination of health care and services covered).
(B) Does not include:
(i) The drug, device or service being tested in an approved clinical trial, unless a coordinated care organization would provide or pay for the drug, device or service if provided to a member who is not enrolled in an approved clinical trial;
(ii) Items or services required solely for the provision of the drug, device or service being tested in an approved clinical trial;
(iii) Items or services required solely for the clinically appropriate monitoring of the drug, device or service being tested in an approved clinical trial;
(iv) Items or services that are provided solely to satisfy data collection and analysis needs associated with an approved clinical trial and that are not used in the direct clinical management of the member; or
(v) Items or services customarily provided by a clinical trial sponsor free of charge to any participant in an approved clinical trial.
(2) A coordinated care organization may not discriminate against a member on the basis of the member’s participation in an approved clinical trial by:
(a) Denying the provision of or payment for routine health care; or
(b) Excluding, limiting or imposing additional conditions on the provision of or payment for routine health care furnished in connection with the member’s participation in an approved clinical trial.
(3) A coordinated care organization that provides routine health care to a member enrolled in an approved clinical trial is not, based on the provision of that care, liable for any adverse effects of the approved clinical trial. [2016 c.26 §5]
Note: Sections 10 and 14, chapter 721, Oregon Laws 2017, provide:
Sec. 10. (1) As used in this section, “health benefit plan” has the meaning given that term in section 2 of this 2017 Act [743A.067 (Reproductive health services)].
(2) In consultation with the Department of Consumer and Business Services, the Oregon Health Authority shall design a program to provide statewide access to abortion coverage for Oregon residents enrolled in health benefit plans described in section 2 (7)(e) and (9) of this 2017 Act.
(3) In developing the design of the program described in subsection (2) of this section, the authority and the department shall consult with consumer advocates, insurers transacting insurance in this state that offer the health benefit plans described in section 2 (7)(e) and (9) of this 2017 Act and other stakeholders.
(4) The authority, in collaboration with the department, shall:
(a) If funding is available, take any actions authorized by state law to implement the program described in subsection (2) of this section; and
(b) Not later than November 1, 2017, report to the Speaker of the House of Representatives, the President of the Senate and the interim committees of the Legislative Assembly related to health:
(A) Any actions taken by the authority under paragraph (a) of this subsection; and
(B) Recommendations for legislative changes necessary to fully implement the program described in subsection (2) of this section. [2017 c.721 §10]
Sec. 14. Section 10 of this 2017 Act is repealed on January 2, 2019. [2017 c.721 §14]
Note: Sections 1 and 3, chapter 95, Oregon Laws 2014, provide:
Sec. 1. Durable medical equipment pilot project. (1) As used in this section:
(a) “Coordinated care organization” has the meaning given that term in ORS 414.025 (Definitions for ORS chapters 411, 413 and 414).
(b) “Durable medical equipment” means equipment that is primarily and customarily used for a medical purpose, can withstand repeated use and is appropriate for use in the home.
(c) “Equipment” means durable medical equipment that was donated by an individual or organization.
(d) “Medical assistance” has the meaning given that term in ORS 414.025 (Definitions for ORS chapters 411, 413 and 414).
(2) The Oregon Health Authority shall contract with one or more nonprofit organizations to operate a pilot project to test whether the authority and coordinated care organizations can achieve good outcomes for individuals who receive medical assistance by reusing durable medical equipment in a safe, functionally appropriate and cost-effective manner. The pilot project does not supplant the durable medical equipment coverage provided by the medical assistance program. The pilot project shall serve recipients of medical assistance who reside in Washington, Multnomah, Clackamas, Umatilla, Marion and Polk Counties. The pilot project may be expanded as the authority deems appropriate.
(3) The pilot project must have all of the following elements:
(a) The capacity to receive, store and transport used equipment.
(b) A web-based, searchable and regularly updated inventory of the equipment that is available for reuse.
(c) A strategy to facilitate sufficient and appropriate equipment donations.
(d) Procedures, adopted by the authority by rule, to ensure that:
(A) Reused equipment is safe and functionally appropriate;
(B) Reused equipment is properly cleaned, sanitized, repaired, refurbished and reconfigured;
(C) There is a streamlined and user-friendly process for requesting equipment, processing the requests, checking the status of requests and maintaining records of requests and distributions of equipment;
(D) The nonprofit organizations properly dispose of equipment or salvage parts from equipment if the equipment is unsuitable for reuse; and
(E) Assistive technology professionals or other appropriately licensed or certified providers, acting in accordance with quality standards adopted by the authority, have the responsibility to:
(i) Assess each individual’s needs for equipment, consult with and advise the individual and the individual’s care provider in the selection of equipment and continue to be available after the delivery of reused equipment to provide timely support, repairs and adjustments; and
(ii) Inspect, adjust, refurbish and fit the reused equipment.
(e) Limits of liability comparable to other providers of services to medical assistance recipients.
(4) The authority shall develop and collect data, including feedback from coordinated care organizations, consumers and health care providers, and analyze the data to assess the success of the pilot project and report the results of the assessment to the Seventy-eighth Legislative Assembly no later than February 1, 2016. The authority shall continue to report annually to the Legislative Assembly until the end of the pilot project.
(5) The authority shall reimburse the nonprofit organizations operating the pilot project, on a fee-for-service basis, for the costs of providing, delivering and servicing each item of equipment provided to individuals eligible for medical assistance who are not members of coordinated care organizations. The authority shall adopt the reimbursement rates by rule.
(6) The authority shall take all actions necessary to implement the pilot project no later than October 1, 2014.
(7) The authority may apply for and receive gifts or grants from any public or private source for the purpose of carrying out this section. [2014 c.95 §1]
Sec. 3. Section 1 of this 2014 Act is repealed April 20, 2018. [2014 c.95 §3]
3 OregonLaws.org assembles these lists by analyzing references between Sections. Each listed item refers back to the current Section in its own text. The result reveals relationships in the code that may not have otherwise been apparent.