HRSA Issues Proposed Rule to Ensure Affordable Access to Lifesaving Medications

U.S. Department of Health & Human Services
Health Resources and Services Administration
Thursday, September 24

Today, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), released a notice of proposed rulemaking (NPRM) to increase access to affordable insulin and injectable epinephrine for low-income Americans in health centers nationwide.

"The Health Center Program provides preventive and primary care services to nearly 30 million medically underserved people annually, including more than 2.7 million people with diabetes," said HRSA Administrator Tom Engels. "Expanding affordable access to lifesaving medications like insulin and injectable epinephrine can significantly improve the health status of patients with chronic diseases, ultimately reducing or even eliminating health disparities that acutely impact underserved and minority communities nationwide."

In response to President Trump's Executive Order 13937, this NPRM proposes to ensure future health center grants available under section 330(e) of the Public Health Service Act are conditioned upon these health centers that purchase insulin and injectable epinephrine through the 340B Drug Pricing Program having established practices to make these drugs available at the discounted price paid under the 340B Program. These discounted drugs will be available to health center patients with low incomes who also have health insurance with a high cost sharing requirement for either insulin or injectable epinephrine, health insurance with a high unmet deductible, or no health insurance.

View the text of the proposed rule, and the NPRM fact sheet (PDF - 55 KB).

For more information about HRSA's Bureau of Primary Health Care, visit:

For more information about HRSA's 340B Drug Pricing Program, visit:

Date Last Reviewed:  September 2020