(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.
Notes
Or. Admin. Code
§
836-200-0520
ID
2-2019, adopt filed 02/26/2019, effective
3/1/2019;
ID
2-2025, amend filed 03/26/2025, effective
4/1/2025
Statutory/Other Authority: ORS
646A.689
Statutes/Other Implemented: ORS
646A.689
