Chiesi Loses Suit Over Drug Strength in Medicaid Rebate Program

Drugmaker Chiesi USA, Inc. failed to convince a federal judge that the Medicaid agency acted unlawfully when it determined what “new formulation” drugs are under its rebate program.

Judge Ana C. Reyes for the US District Court for the District of Columbia affirmed Wednesday the agency’s “new formulation” definition under the Medicaid Drug Rebate Program, ruling against Chiesi’s claims that the government overstepped its statutory authority and acted arbitrarily and capriciously when it created the meaning.

“CMS reasonably embraced the statute’s flexibility in its Final Rule,” Reyes said in the decision. “CMS’s reading also makes linguistic and legal sense.”

Manufacturers ...