Or. Admin. Code § 836-200-0532 - Prescription Drug Reporting - Patient Assistance Programs

(1) If a reporting manufacturer offers one or more patient assistance programs to consumers residing in Oregon to reduce consumer out-of-pocket costs for a drug meeting the conditions specified in OAR 836-200-0515, the report furnished to the department under OAR 836-200-0530(2) must have an appendix that includes at least the following information for each patient assistance program relevant to the drug that is the subject of the report:

(a) The number of consumers residing in Oregon who participated in the patient assistance program over the previous calendar year;

(b) The total dollar value of the coupons, discounts, copayment assistance or other reduction in costs provided to consumers residing in Oregon who participated in the patient assistance program over the previous calendar year;

(c) For each drug, the number of refills that qualify for the program, if applicable;

(d) If the program expires after a specified period of time, the period of time that the program is available to each consumer; and

(e) The eligibility criteria for the program and how eligibility is verified for accuracy.

(2) If a reporting manufacturer provides funding for an independent patient assistance program that reduces consumer out-of-pocket costs for a drug meeting the conditions specified in OAR 836-200-0515, the report furnished to the department under OAR 836-200-0530(2) must have an appendix that provides the name of the independent program and includes all of the information specified in section (1) that is available to the manufacturer at the time of the report. If the independent program provides services in addition to reducing consumer out-of-pocket costs for the drug that is the subject of the report, the manufacturer may limit the information provided to the information applicable to the drug that is the subject of the report. Reporting manufacturers that provide funding for independent patient assistance programs must act in good faith to secure this information.

(3) Reporting manufacturers that provide funding for a bona fide Independent Charity Patient Assistance Program operating in full compliance with the guidance provided in the Department of Health and Human Services Office of the Inspector General's Supplemental Special Advisory Bulletin: Independent Charity Patient Assistance Programs (Federal Register / Vol. 79, No. 104 / Friday, May 30, 2014 / Notices) are not required to include information about the bona fide Independent Charity Patient Assistance Program in any appendix required by this rule.

Notes

Or. Admin. Code § 836-200-0532

ID 2-2025, adopt filed 03/26/2025, effective 4/1/2025

Statutory/Other Authority: ORS 646A.689

Statutes/Other Implemented: ORS 646A.689