The U.S. Department of Health and Human Services (HHS) announced last month that the Health Resources and Services Administration (HRSA) is working on two new proposed 340B Drug Pricing Program regulations. These regulations are separate from the upcoming mega reg, which addresses a range of critical 340B regulatory matters and other legislative issues and may be released in July.

The first new regulation, scheduled to be released in December, addresses the extent to which state AIDS Drug Assistance Programs that pay health insurance premiums, copayments, and deductibles for program clients can collect 340B rebates from drug manufacturers. The second new regulation, due to be released in February, would clarify how National Hemophilia Program Regional Hemophilia Network grantees can use support from the 340B program. Hemophilia treatment centers have previously asked for clarification on whether they can use support from the 340B program for research, patient assistance, and education and training.