(1) A health benefit plan, as defined in ORS § 743B.005:

(a) Shall provide coverage for the routine costs of the care of patients enrolled in and participating in approved clinical trials;

(b) May not exclude, limit or impose additional conditions on the coverage of the routine costs for items and services furnished in connection with participation in an approved clinical trial; and

(c) May not include provisions that discriminate against an individual on the basis of the individual’s participation in an approved clinical trial.

(2) As used in this section, ‘routine costs’:

(a) Means all medically necessary conventional care, items or services consistent with the coverage provided by the health benefit plan if typically provided to a patient who is not enrolled in a clinical trial.

(b) Does not include:

(A) The drug, device or service being tested in the approved clinical trial unless the drug, device or service would be covered for that indication by the health benefit plan if provided outside of an approved clinical trial;

(B) Items or services required solely for the provision of the drug device or service being tested in the clinical trial;

(C) Items or services required solely for the clinically appropriate monitoring of the drug, device or service being tested in the clinical trial;

(D) Items or services that are provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient;

(E) Items or services customarily provided by a clinical trial sponsor free of charge to any participant in the clinical trial; or

(F) Items or services that are not covered by the health benefit plan if provided outside of the clinical trial.

(3) As used in this section, ‘approved clinical trial’ means a clinical trial that is:

(a) Funded by the National Institutes of Health, the Centers for Disease Control and Prevention, the Agency for Healthcare Research and Quality, the Centers for Medicare and Medicaid Services, the United States Department of Defense or the United States Department of Veterans Affairs;

(b) Supported by a center or cooperative group that is funded by the National Institutes of Health, the Centers for Disease Control and Prevention, the Agency for Healthcare Research and Quality, the Centers for Medicare and Medicaid Services, the United States Department of Defense or the United States Department of Veterans Affairs;

(c) Conducted as an investigational new drug application, an investigational device exemption or a biologics license application subject to approval by the United States Food and Drug Administration; or

(d) Exempt by federal law from the requirement to submit an investigational new drug application to the United States Food and Drug Administration.

(4) The coverage required by this section may be subject to provisions of the health benefit plan that apply to other benefits within the same category, including but not limited to copayments, deductibles and coinsurance.

(5) An insurer that provides coverage required by this section is not, based upon that coverage, liable for any adverse effects of the approved clinical trial.

(6) This section is exempt from ORS § 743A.001. [2009 c.274 § 2; 2013 c.681 § 34]