MN HF2518

Manufacturers of prescription drugs with a wholesale acquisition cost of $10,000 or more annually or per course of treatment must file annual cost reports with the commissioner beginning May 1, 2020.

Reports must include total production costs broken down by research and development, clinical trials and regulatory costs, materials and manufacturing, government-funded research, patent/licensing acquisitions, and marketing and advertising expenses.

Reports must document cumulative annual history of average wholesale price (AWP) and wholesale acquisition cost (WAC) increases expressed as percentages, total profit attributable to the drug, and financial assistance provided through patient prescription assistance programs.

All reported information must be itemized, documented by manufacturers, and audited by an independent third-party auditor prior to filing.

The commissioner shall issue an annual report to the legislature by August 1, 2020, and each year thereafter summarizing submitted information and making it available to the public on the agency website.