Annual vs. One-Time: Deconstructing State Drug Price Transparency Registration Requirements
In Part 1 of our series, we introduced the critical role of state drug price transparency registrations in ensuring compliance. Now, we’ll dive deeper into the two primary types of registrations you’ll encounter: recurring annual registrations and one-time registrations, highlighting specific state examples to illustrate their unique demands.
Required Annual Registrations: The Yearly Check-in
For states with annual registration mandates, compliance is an ongoing, yearly commitment. These programs require reporting entities to revisit their registration information regularly, ensuring that state agencies always have the most current details for effective communication and regulatory oversight. Missing these annual updates can lead to compliance gaps and missed opportunities for vital program information.
- New Jersey Drug Affordability Unit (Division of Consumer Affairs): Pursuant to NJ S1615, reporting entities are mandated to register with the Division by January 31st of each calendar year through the Division website. This annual deadline requires proactive attention to ensure continued compliance.
- Maine Health Data Organization (MHDO): Under 90-590 C.M.R. Chapter 570, reporting entities must complete an annual registration form each year via the MHDO Prescription Drug Price Data Portal. This is the designated time to update and/or confirm all company and contact information.
One-Time Registrations with a Catch: The Importance of Portal Access
While seemingly less frequent, one-time registrations often come with stringent rules about maintaining up-to-date information and, critically, continuous portal access. States like Oregon and Minnesota exemplify this, placing a high value on having reliable access to their online systems.
These states highly recommend having more than one contact person associated with the company account. Why? Because losing portal access can be incredibly difficult to regain, potentially leading to late filings and associated penalties. Imagine a key contact leaves the company, or login credentials are forgotten – without a backup, your ability to submit reports on time could be severely compromised.
Crucially, these states often allow for the establishment of third-party accounts. This feature is an invaluable asset for reporting entities, as it allows service providers like State DPT Servicing, Inc. to establish access and report on behalf of their clients. This ensures seamless operations, even if internal contact persons change or access is temporarily lost. Additionally, it means the third-party also receives copies of important email notices from the department, providing an extra layer of awareness.
- Oregon Department of Consumer and Business Services (DCBS): Pursuant to OAR 836-200-0510, prescription drug manufacturers licensed by the Oregon Board of Pharmacy are required to register through the iReg system. Maintaining iReg system access via a primary contact user with appropriate permissions is paramount. Oregon also leverages email to send “demand to pay notices” (OAR 836-200-0553), underscoring the necessity of accurate contact information in the registration.
- Minnesota Department of Health – Rx Transparency: To gain system access for submitting reports in Minnesota’s DPT portal, a manufacturer must complete the system registration, designate a primary company contact, and activate that primary contact account in accordance with Minnesota Statute 62J.84.
Understanding whether your obligations involve an annual check-in or a one-time setup with critical ongoing maintenance is fundamental to a successful drug price transparency compliance strategy.
In our final piece, Part 3, we’ll address the unique challenges of states with no formal registration requirements and offer a comprehensive review of why proactive contact with regulatory authorities is key.
Ready to ensure your state registrations are watertight? Contact State DPT Servicing, Inc. today to discuss how we can streamline your compliance processes.