OAR 836-200-0525
Expectations of Reporting Manufacturers


(1) Reporting manufacturers must make a good-faith effort to include all of the information required in a report or a response to a request for additional information under OAR 836-200-0530 (Form and Manner Requirements for Drug Pricing Reporting) and 836-200-0535 (Additional Information Requests), and conduct a reasonable investigation to ensure the accuracy and completeness of their reports.
(2) If any of the information required in a report or a response to a request for additional information under OAR 836-200-0530 (Form and Manner Requirements for Drug Pricing Reporting) and 836-200-0535 (Additional Information Requests) is not available to the reporting manufacturer at the time of the filing due to circumstances outside the manufacturer’s control, the manufacturer must provide any available portion of the required information and a thorough explanation. The explanation must include a description of the missing information and the circumstances contributing to the manufacturer’s inability to meet the requirement.
(3) If the information required in a report or a response to a request for additional information under OAR 836-200-0530 (Form and Manner Requirements for Drug Pricing Reporting) and 836-200-0535 (Additional Information Requests) is not currently available to the manufacturer but is expected to be available in the future, the manufacturer must provide an explanation and a timeline for providing the required information to the department.
(4) Reporting manufacturers must make a good-faith effort to limit information provided to the department to information that is necessary for the director’s review and analysis of drug prices under 2018 Or Laws ch 7.
(5) A reporting manufacturer’s failure to comply with the expectations specified in (1)-(4) of this section may subject the manufacturer to a civil penalty under OAR 836-200-0560 (Civil Penalties).

Source: Rule 836-200-0525 — Expectations of Reporting Manufacturers, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=836-200-0525.

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
Last Updated

Jun. 8, 2021

Rule 836-200-0525’s source at or​.us