In recent years, drug pricing decisions have come under increased scrutiny as state governments seek to regulate the impact of Pharmaceutical manufacturers’ pricing decisions on patients. Beginning with Vermont in 2016, more than 30 unique drug price transparency requirements have been enacted at the state level, with additional pending legislation on the way. Manufacturers can only expect this number to increase as costs continue to rise for Federal and State-sponsored health plans, leading to an ever-challenging compliance landscape for Life Sciences companies to navigate.
Key State Drug Price Report Types
State drug price reporting can take many forms. A single pricing decision can trigger several reporting requirements within a single state depending on the product type.
- New Product Reports: Manufacturers may have to submit reports when introducing a new drug to the market. In some jurisdictions, the reporting obligation is only triggered when the product’s wholesale acquisition cost (WAC) exceeds a certain threshold while in others, the obligation is unrelated to the product’s WAC. Some states may even require notice before the manufacturer introduces the product to the market.
- Periodic Reports (Quarterly & Annual): Certain jurisdictions require manufacturers to report pricing data quarterly or annually.
- Price Increase Reports (Pre & Post Price Increase): Manufacturers increasing the price of a particular product may need to submit reports to several states if the price increase exceeds certain thresholds. Depending upon the jurisdiction where reporting is triggered, these reports may be due before or after the price increase takes effect.
- Upon Jurisdiction Request: Several states proactively request pricing data from manufacturers of products that meet specific pre-defined criteria. Manufacturers may be informed that they must submit pricing data to a particular state via email, online portal or when the applicable governing authority posts lists of qualifying products to its website.
- Disclosure to HCPs: Although not the most common reporting requirement, some states require manufacturers to provide HCPs with a product’s pricing information when marketing or otherwise promoting the product.
- Prescription Drug Affordability Boards: A recent trend among states interested in better understanding drug pricing is the creating and implementing of Prescription Drug Affordability Boards (PDABs). Generally, PDABs are tasked with gathering and analyzing pricing data to better understand the costs associated with products deemed “essential” for patient care as well as those which have a significant impact on state-funded healthcare programs.
How MedPro Systems Can Help
State drug price reporting requirements for any given pharmaceutical manufacturer vary by state as well as product type being sold or introduced to the market. Whether a manufacturer is launching a new product or increasing its current price structure, it’s critical they’re aware of how their pricing decisions can trigger reporting obligations across the country.
MedPro makes it easy for manufacturers to drive informed pricing decisions with the authoritative transparency reference library solution, RegulatoryID. Stay up-to-date on new and evolving state drug pricing regulations and quick search reporting deadlines, product type specific requirements, submission prerequisites, and more by state. Plus, access our centralized disclosure compendium of all US & Global Aggregate Spend requirements paired with compliance expertise.
Please contact us to learn more about MedPro’s US State Drug Price Reporting solution.