OAR 836-200-0520: Threshold for Reporting New Prescription Drug

(1) For new prescription drugs introduced on or after March 15, 2019, with a price for a one-month supply that exceeds the threshold established by the Centers for Medicare and Medicaid Services for specialty drugs in the Medicare Part D program, the manufacturer must report to the department the information described in OAR 836-200-0531. (2) For new prescription drugs introduced on or after January 1, 2025, the threshold is $950, which is the dollar amount specified for minimum Medicare Part D specialty tier eligibility in the 2024 Final Call Letter from the Centers for Medicare and Medicaid Services. (3) For new prescription drugs introduced prior to January 1, 2025, the threshold is $670, which is the dollar amount specified for minimum Medicare Part D specialty tier eligibility in the 2018 Final Call Letter from the Centers for Medicare and Medicaid Services. (4) The date of introduction is the FDA start marketing date or the date the product is first available for purchase in the United States, whichever is later.