Oregon Department of Consumer and Business Services, Insurance Regulation

Rule Rule 836-200-0505
Definitions


For purposes of 836-200-0500 (Purpose and Statutory Authority) to 836-200-0560 (Civil Penalties), the following definitions apply, unless the context requires otherwise:
(1) “Course of treatment” means the total dosage of a drug that would be prescribed in a single prescription to a patient taking the drug as recommended by its prescribing label as approved by the federal Food and Drug Administration. If there is more than one such recommended dosage, the largest recommended total dosage will be considered for the purposes of determining a course of treatment.
(2) “Developed by the manufacturer” means, for a prescription drug, that its research and development costs were funded by the manufacturer in whole or in part through Phase I, II, or III trials as defined in 21 CFR 312.21.
(3) “Inaccurate information” means false or misleading representations or statements.
(4) “Incomplete information” means representations or statements that fail to provide all available information required in a report or in response to a request for additional information under OAR 836-200-0515 (Threshold for Reporting Drug Price Increase) to 836-200-0535 (Additional Information Requests).
(5) “Net yearly increase” means an increase in the wholesale acquisition cost of a drug over the course of a calendar year, calculated by dividing the average wholesale acquisition cost of the drug over the course of a calendar year by the average wholesale acquisition cost over the course of the previous calendar year.
(6) “New prescription drug” means a prescription drug that has received initial approval under an original new drug application under 21 U.S.C. 355(b), under an abbreviated new drug application under 21 U.S.C. 355(j), or under a biologics license application under 42 U.S.C. 262. In cases where multiple products are included on an application, each product will be considered a new prescription drug. A new prescription drug’s introduction date is the date of its market entry.
(7) “One-month supply” means the total daily dosage units of a prescription drug recommended by its prescribing label as approved by the federal Food and Drug Administration for 30 days. If there is more than one such recommended daily dosage, the largest recommended daily dosage will be considered for the purposes of determining a one-month supply.
(8) “Price” means the wholesale acquisition cost of a prescription drug.
(9) “Price increase” means any increase in the wholesale acquisition cost of a prescription drug.
(10) “Public funds” means any funds granted, loaned or otherwise provided by a national, state, local or foreign government entity.
(11) “Reporting manufacturer” means an entity:
(a) Required to be registered with the Oregon Board of Pharmacy as a drug manufacturer;
(b) That engages in the manufacture of prescription drugs as defined by 2018 Or Laws ch 7; and
(c) That sets or changes the wholesale acquisition cost of the drugs it manufacturers.
(12) “The threshold established by the Centers for Medicare and Medicaid Services for specialty drugs in the Medicare Part D program” means $670, which is the dollar amount specified for minimum Part D specialty tier eligibility in the 2018 Final Call Letter from the Centers for Medicare and Medicaid Services.
(13) “Timely” and “timely manner” mean in compliance with the required deadlines for reporting and providing responses to requests for additional information detailed in OAR 826-200-0515 to 826-200-0535.
(14) “Wholesale acquisition cost” has the meaning given the term in 42 U.S.C. 1395w-3a(c)(6)(B).
Source

Last accessed
Jun. 8, 2021