The US Department of Health and Human Services (HHS) issued new guidance clarifying how pharmaceutical manufacturers can offer lower-cost prescription drugs directly to patients, including those enrolled in Medicare and Medicaid, without triggering enforcement under the federal anti-kickback statute, provided specific safeguards are met. The announcement marks a significant policy development as the Trump administration continues to advance efforts aimed at reducing drug prices and increasing transparency in the prescription drug market.1What was included in the guidance? “Americans pay too much for prescription drugs because middlemen profit from a system patients can’t see,” said HHS secretary Robert F. Kennedy, Jr. in the agency’s press announcement.1 “This guidance makes clear that manufacturers can offer lower-cost drugs directly to patients without kickbacks or taxpayer billing. “We are taking action to give patients more options while keeping strong guardrails in place,” said CMS Administrator Mehmet Oz, MD, in the press announcement.1 “When patients can access affordable medicines without hidden incentives or gamesmanship, outcomes improve and prices come down. Taken together, the actions of HHS are designed to provide drugmakers with clearer parameters for offering lower-priced, direct-purchase options while preserving oversight of federal health care spending.