OAR 836-200-0520
Threshold for Reporting New Specialty Drug

Beginning March 15, 2019, 30 days or less after a manufacturer introduces a new prescription drug for sale in the United States at a price for a 30 day supply or for a course of treatment lasting less than one month 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 836-200-0530 (Form and Manner Requirements for Drug Pricing Reporting) (4).

Source: Rule 836-200-0520 — Threshold for Reporting New Specialty Drug, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=836-200-0520 (accessed May 26, 2025).

836–200–0000
Statutory Authority 836–200–0010
Assessments 836–200–0020
Filing Procedures 836–200–0030
Form 10 K and Other Financial Stability Filings 836–200–0040
Reimbursement Insurance Policy 836–200–0050
Registration Requirements Not Exclusive 836–200–0055
Annual Report 836–200–0060
Service on Registrant 836–200–0100
Notice, Collision Damage Waivers 836–200–0105
Statutory Authority 836–200–0110
Registration Procedures 836–200–0120
Warranty 836–200–0130
Reimbursement Insurance Policy 836–200–0140
Registration Requirements Not Exclusive 836–200–0200
License, Discount Medical Plan Organization 836–200–0210
Renewal of expired license 836–200–0215
One-time processing fee, cancelled application 836–200–0220
License Requirement Not Exclusive 836–200–0250
Purpose and Authority 836–200–0255
Registration of Contracting Entity 836–200–0300
Statement of Purpose 836–200–0305
Retainer Medical Practice Application for Certification 836–200–0310
Retainer Medical Practice Application for Renewal 836–200–0315
Disclosures 836–200–0401
Statement of Purpose 836–200–0406
Application Requirements for Pharmacy Benefit Manager 836–200–0411
Renewal of Pharmacy Benefit Registration 836–200–0416
Registration Requirements Not Exclusive 836–200–0421
Service on Registrant 836–200–0436
Submission of Complaints 836–200–0440
Market Conduct Requirements for Pharmacy Benefit Managers 836–200–0500
Purpose and Statutory Authority 836–200–0505
Definitions 836–200–0510
Account Generation Requirement 836–200–0515
Threshold for Reporting Drug Price Increase 836–200–0520
Threshold for Reporting New Specialty Drug 836–200–0525
Expectations of Reporting Manufacturers 836–200–0530
Form and Manner Requirements for Drug Pricing Reporting 836–200–0535
Additional Information Requests 836–200–0540
Information Claimed to be Trade Secret 836–200–0545
Public Disclosure of Prescription Drug Manufacturer Filings 836–200–0550
Consumer Notices to the Department 836–200–0555
Assessments Against Prescription Drug Manufacturers 836–200–0560
Civil Penalties

May 26, 2025

Rule 836-200-0520's source at or​.us