Covered entities in the 340B Discount Drug Program now can verify that drug manufacturers are charging them no more than the “ceiling price” for a given drug. On Monday, April 1, the Office of Pharmacy Affairs (OPA), the agency within the Health Resources and Services Administration (HRSA) that oversees the 340B program, released a new version of the OPA Information System (OPAIS) that includes a tool for checking ceiling prices for 340B drugs (Ceiling Price Database).  The Affordable Care Act required HRSA to make a tool to verify ceiling prices available, but implementation has been delayed repeatedly by postponed final regulations, lawsuits, and operational challenges within OPA. Just last year, the American Hospital Association and other hospital trade groups sued HRSA for failing to finalize the ceiling price regulations.

Covered entities should begin checking that they are being charged accurately for 340B drugs each quarter. If your covered entity finds a discrepancy, contact Michael Glomb at mglomb@feldesman.com. Drug manufacturers who knowingly and intentionally overcharge covered entities may be subject to civil monetary penalties from HRSA.