HHS OIG releases bulletin on direct-to-consumer drug sales, RFI on need for regulatory changes

The Department of Health and Human Services Office of Inspector General Jan. 27 released a bulletin addressing how direct-to-consumer drug programs can sell prescription drugs to patients with federal health care program coverage at lower costs without violating the Anti-Kickback Statute. The bulletin explains conditions drug manufacturers must meet to sell products to cash-paying consumers. This includes ensuring that the products are not billed to Medicare, Medicaid or other federal programs; used to market other federally reimbursable products; or tied to future purchases or referrals. Additionally, the HHS OIG yesterday issued a request for information seeking feedback on the need for any regulatory modifications to safe harbors under the Anti-Kickback Statute or exceptions under the beneficiary inducements civil monetary penalty to support direct-to-consumer drug sales.