HB 5223 Summary

• Requires prescription drug manufacturers to file annual reports with the Department of Health and Human Services beginning January 1, 2019, for drugs with an annual wholesale acquisition cost of $10,000 or more or $10,000+ per course of treatment distributed in Michigan.

• Reports must include itemized accounting of manufacturing and distribution costs, research and development costs (including government-funded and after-tax costs), acquisition costs, and marketing/advertising expenses.

• Reports must document each price increase during the year (as percentage and date), wholesale acquisition cost increases, total profit expected and derived from drug sales, and international pricing information.

• Manufacturers must obtain independent third-party audits of reports before filing; audit costs are paid by the manufacturer and audit summaries filed by May 1 annually.

• Establishes the Prescription Drug Cost Advisory Commission with representatives from pharmaceutical industry, insurers, HMOs, pharmacy benefit managers, consumers, and prescribers to analyze data and make policy recommendations; Department of Health and Human Services maintains searchable public database of reported information.

• Manufacturers failing to file required reports are subject to a $100,000 administrative fine.