Manufacturers

Registration requirements: 

Prescription drug manufacturers that meet the definition of a reporting manufacturer are required to register with the Drug Price Transparency Program and pay an annual assessment to cover program expenses. Some companies have multiple entities in their organization that meet this definition so each entity must be registered and pay the annual assessment. Reporting manufacturers pay an annual fee currently due Oct. 1. An entity is a reporting manufacturer, if it meets all of the following:

• Required to register with the Oregon Board of Pharmacy as a drug manufacturer
• Manufactures prescription drugs as defined by ORS 646A.689(1)(d)
• Sets or changes the wholesale acquisition cost (WAC) of those drugs

iReg system access:

iReg is Oregon's system for manufacturers to submit reports, view correspondence, provide additional reporting information, and view assessments. An iReg account is created when a reporting manufacturer is initially registered with the program.

Due to the large number of companies registered with the program, we ask that manufacturers manage access for users whenever possible. Every company should have at least one registered user with the appropriate permissions to manage users on the manufacturer's account. There should be at least one person who is a user and one person who is a contact, with at least two different people in the company as users or contacts. A user is someone who can view the account information in iReg, submit reports, and view billing information. A contact is someone who receives notices, such as when we send correspondence. It is important to mark all the boxes to receive all types of notices. The company is responsible for keeping current both your user and contact information.

Find instructions on user management in our Manufacturer User Guide. If you have questions or need help, email rx.prices@dcbs.oregon.gov.

iReg reporting system

Submitting drug reports

All reporting manufacturers are required to report on prescription drug price increases and on new prescription drugs that meet the threshold reporting requirements. Do not submit reports that are not required. After reviewing the user guide, let us know if you have questions about whether to submit and what information is required. You can email us at rx.prices@dcbs.oregon.gov.

The Manufacturer User Guide is meant to help reporting manufacturers comply with the requirements in ORS 646A.680 through 646A.692 and OAR 836-200-0500 through OAR 836-200-0560 for Oregon's Drug Price Transparency Program.

New drug reporting:

• A report is required, within 30 days of introduction, for each prescription drug National Drug Code (NDC) for sale in the U.S. when the price of the NDC exceeds the threshold set by the Centers for Medicare and Medicaid Services in Medicare Part D for a 30-day supply or for a course of treatment lasting less than one month. The threshold was set when the program began and is $670 per OAR 836-200-0505.

Annual price increase reporting:

ATTENTION: The iReg system has been updated to accept revised filings for annual price increase reports as indicated in DFR Bulletin No. 2024-3. The due date for the revised filings has been extended to May 15, 2024.

A report is required by March 15 for each NDC when the following criteria are met:

• The average price for the calendar year that just ended (reporting year) is compared to the average price for the previous calendar year (comparison year) and the price has increased by 10 percent or more. Here, average price means the weighted average of the WAC prices of the drug package from the calendar year, with each price weighted according to how many days it was in effect. Refer to the user guide for more information.
• The price at any point during the reporting year was $100 or more for a one-month supply, or for a course of treatment lasting less than one month.
  
• There was a patient assistance program available in Oregon for the drug during the reporting year, even if there were no Oregon participants.
• Example 1: A package of Drug A contains a three-month supply of the drug; the average price of the package was $700 for 2022 (comparison year) and $850 for 2023 (reporting year), and there was patient assistance available to Oregonians. The price for a one-month supply of Drug A was higher than $100 in 2023, and the increase of the average price comparing the two years is greater than 10 percent, so a report is required for Drug A by the extended due date of May 15, 2024.
  

Sixty-day notice price increase reporting:

• A report is required 60 days before a price increase for each NDC for a brand-name prescription drug when the planned price increase is 10 percent or more OR the increase is $10,000 or more.
• Example 2: A brand-name prescription drug's WAC is $500 and there is a plan to increase it to $600. This increase is more than 10 percent, so a report is filed at least 60 days before that price increase.
  
• A report is required 60 days before a price increase for each NDC for a generic prescription drug when the planned price increase is 25 percent or more AND the increase is $300 or more.
• Example 3: A generic prescription drug's WAC is $200 and there is a plan to increase it to $300. This increase is more than 25 percent, but the increase is less than $300, so a report is not filed.
  
• There are more examples and information on the report filing requirements in Bulletin No. 2020-12.
• Exceptions: No report is required if the prescription drug is manufactured by four or more companies and meets one of the criteria listed in ORS 646A.683(4).

Biscom access:

We use Biscom to securely communicate information claimed as trade secret. We will generally send access instructions to the user who submitted the report with claimed trade secrets. If we send communication in Biscom, we will also add a message in iReg. Those listed as contacts for a manufacturer are automatically notified when a message is posted in iReg if they have all required notices selected on their contact profile. It is important that users and contacts are up to date and the correct people are receiving the notices. A manufacturer only needs access to Biscom if we issue a trade secret determination. Here are instructions about using Biscom, but remember that Biscom is only used to receive a trade secret determination and you will not reply to us using Biscom: external user guide

Billings and collections

Manufacturers owe an assessment each year. The fee structure has changed for billing periods starting on or after Aug. 1, 2023. Demand to pay notices are sent by email 30 days before the assessment is due to the contacts on the account in iReg. Labeler information, billing details, payment vouchers, and fiscal details can be viewed by logging into iReg. 

For billing periods starting on or after Aug. 1, 2023, the manufacturer fees are based on size categories. The size categories are small, medium, and large using the count of NDC package codes for Food and Drug Administration (FDA) approved prescription drugs listed in the FDA NDC directory during the billing period for the manufacturer:

• Small size category: 10 or fewer NDCs
• Medium size category: 11 to 39 NDCs
• Large size category: 40 or more NDCs 

Exception: For reporting manufacturers where all NDCs used for billing purposes on the account have an FDA market category of ANDA (approved under an abbreviated new drug application) or NDA authorized generic (approved as a new drug application for an authorized generic version of a brand name drug), or are products that are biosimilars where the proprietary and nonproprietary name are the same (approved under a BLA, biologics license application), there is no large size category. In these cases, there are two size categories: medium (40 or more NDCs) and small (39 or fewer NDCs).

Before annual assessments are posted, manufacturers have 30 days to review their size category for the upcoming billing period and provide information if they do not agree. During the review period, we will post the size categories for all registered manufacturer accounts active during the billing period and email iReg contacts that their size category is available to review. If a request for a change to a manufacturer's size category is not received during the 30-day review period, the size category becomes final. Timely requests will be reviewed and contacts will be notified of the results. Contacts on any other accounts affected will also be notified and given an opportunity to provide additional information about their products.

Remember that some accounts are reporting manufacturers responsible for multiple labeler names and those NDCs are also part of the size category for that account. 

For those registered prior to Aug. 1, 2024, the review period and deadline to submit a change request for the 2024 billing was Aug. 31, 2024. The program completed reviews of all timely requests and updated the size categories list for 2024.

Manufacturer size categories for 2024 billing

For all manufacturers who owe the 2024 assessment, including those with a late registration, the amount owed by each manufacturer is based on their size category and those amounts are:

• Large size category:$16,145
  
• Medium size category:$6,570
  
• Small size category:$680

The 2024 assessments are posted in iReg and are due Nov. 1, 2024.

Contacts on the account are emailed after assessments are posted in iReg and receive a demand to pay notice 30 days before the due date.

Future billing periods will be based on a calendar year and assessments and demand to pay notices will be issued in the spring or early summer after the calendar year has ended.

You can download our Form W-9, if needed. Here is our mailing and physical address for sending payments: 

Refer to “Assessment and collections" in our Manufacturer User Guide. Manufacturer accounts with unpaid billings sent to collections will show a banner message in iReg that states “In Collections" on the blue bar near the top of the page.

 

Questions? Email rx.prices@dcbs.oregon.gov.

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