H.R. 3134: Emergency Access to Insulin Act of 2023

This bill reduces the marketing exclusivity period for biological drug products from 12 to 7 years and establishes policies and programs designed to increase access to prescription insulin.

Specifically, the bill requires the Department of Health and Human Services (HHS) to award grants to states to create insulin card programs, which provide uninsured or underinsured individuals with insulin at no cost for specified time periods. Payments for insulin prescriptions made through the program must count toward an underinsured individual’s health plan deductible or other out-of-pocket expenses required under the plan. Further, HHS must collect annual fees from insulin manufacturers, based on each manufacturer’s market share, equal to the total estimated expenditures under the insulin grants program.

Subject to certain exceptions, the bill also establishes an excise tax on insulin manufacturers when the price of an insulin product spikes. The tax amount is a specified percentage of the revenue a manufacturer received as a result of the price spike. The tax amount increases in tiers based on the percentage of the price spike for that product.

Written by the Congressional Research Service, Library of Congress.