New laws impacting reporting requirements happen several times a year in the State Drug Price Transparency world, but it’s less common to get an existing law suspended as part of a court ruling. Within the last three months, we’ve had both.
New York State Assembly Enacts Drug Price Transparency Law A1707A
New York enacted Assembly Bill A1707A in late December 2023. This new law requires prescription drug manufacturers to provide at least 60 days advance notice to the Department of Financial Services (DFS) when drugs with a WAC of $40 per course of therapy have an increase of more than 16%, including the proposed increase and the cumulative increases that occurred within the previous 24 months prior to the planned effective date of the increase.
This 60-day Advance Notice report must include (along with WAC pricing and product data) an explanation of whether a change or improvement in the drug necessitates the price increase and, if so, a description of that change or improvement. DFS plans to post this Advance Notice information on their website within 5 days of receipt.
The law takes effect 180 days after it was signed, so by late June 2024 manufacturers must have this reporting requirement included in their tracking databases and be ready to file this Advance Notice report for all qualifying increases.
US District Court Declares Parts of Oregon Law Unconstitutional
Meanwhile, an interesting US District Court ruling last week declared that portions of an Oregon State Transparency law were unconstitutional – particularly focused on the requirement to disclose marketing and R&D spending when submitting price increase reports. The Oregon Department of Consumer and Business Services (DCBS) believes the ruling was incorrect and plans to appeal, but for the time being, Oregon has indefinitely suspended this reporting requirement (while noting that their New Drug Reporting and 60-Day Advance Notice reporting requirements are still active).
An interesting point to watch related to this ruling is whether it will impact other states and their data collection requirements for new drug and price increase reporting. For example, Minnesota requires manufacturers to submit direct costs associated with manufacturing, distributing, and marketing new drugs above the Specialty Drug Threshold. Utah and Virginia (among others) have requirements in their Price Increase Reports for the submission of R&D amounts spent.
All this recent State Transparency activity highlights the need for manufacturers to either devote extensive research and focus to their state transparency reporting requirements or partner with a service provider who covers it for them.
In addition to our expertise within the State Transparency space, Pharosity partners with external legal counsel to ensure that our State Transparency database is accurate and up to date. Our STARS (State Transparency Analytic Reporting System) tool is built on that law library database and quickly integrates new laws and their key data points (types of reports, filing requirements, triggers/thresholds, due dates, penalties / fines, key contacts, and URL links) into the system.
STARS can also very quickly activate and deactivate existing reporting requirements. This functionality can provide your team with a complete snapshot of your current and future reporting requirements. If needed, our team has the expertise to also prepare and submit those reports on your behalf when they are due.
Contact us at info@pharosity.com for more information or to schedule a STARS demo!