Publication Feature: Risks to the 340B Drug Pricing Program
CRS is excited to share a publication of the Viewpoint, “Risks to the 340B Drug Pricing Program Related to Manufacturer Restrictions on Drug Availability,” in JAMA, written by CRS fellow Ryan Knox and CRS Faculty Dr. Ameet Sarpatwari and Dr. Aaron S. Kesselheim.
The article draws attention to the fact that 16 manufacturers (and counting) have restricted the delivery of discounted drugs to external pharmacies connected with health care centers covered under the 340B Drug Pricing Program, threatening patients’ access to medicines. Created in 1992, the 340B program requires manufacturers participating in Medicaid to sell drugs at substantial discounts to participating providers, which can then charge non-discounted prices to payors and use the revenue earned to subsidize the care they provide, including the provision of low-cost medications for several therapeutic areas such as diabetes and HIV/AIDS.
The restrictions—prompted in part by concerns over diversion (the dispensing of 340B drugs to patients whose prescriptions were written by clinicians at non-340B centers) and duplicate discounting (the receipt of 340B discounts and Medicaid rebates) have led to multiple lawsuits. Federal district courts hearing these cases have reached different conclusions, some finding the manufacturers’ restrictions were improper and others finding the restrictions not prohibited by the 340B statute. While these decisions are appealed, no courts have yet required manufacturers comply with the current 340B program requirements, emboldening more manufacturers to restrict their participation in the 340B program.
Congress could step in to remedy this situation by explicitly permitting contract pharmacies under the 340B program and by delegating rulemaking powers to the Health Resources and Services Administration, the agency within the Department of Health and Human Services that administers the 340B program. These steps would facilitate care and support access to medicines for populations in need.
For open access to the Viewpoint, click here.