PharmaEssentia Challenges Medicare Decision in Part D Redesign

PharmaEssentia USA Corp. is seeking to block the Medicare agency’s determination that the company doesn’t qualify for a gradual phase-in of required manufacturer discounts under the new Medicare Part D Manufacturer Discount Program.

The biopharmaceutical company filed a lawsuit Wednesday in the US District Court for the District of Columbia alleging the Centers for Medicare & Medicaid Services unlawfully relied on incomplete data to determine PharmaEssentia isn’t a “specified small manufacturer,” a designation for when the total “costs” of a manufacturer’s drugs to Part D plans are highly concentrated in a single drug. That label would allow it to offer ...