§ 414.770 — Participants in clinical trials

Oregon § 414.770

• Jurisdiction: Oregon
• Vol.: 11
• Title 34: Human Services; Juvenile Code; Corrections
• Ch. 414: Medical Assistance

Text

(1) As used in this section:
(a) “Approved clinical trial” has the meaning given that term in ORS 743A.192.
(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.
(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.

Legislative History

2016 c.26 §5