New Combo Products Exempt From Medicaid Rule Applying Price Inflation Rebates To Line Extensions
CMS final rule narrows definition of new formulations potentially subject to much higher Medicaid rebates and delays effective date of provisions targeting health plan copay accumulator programs.
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Federal district court decision in Medicaid line extension dispute brought by Vanda against CMS also has implications for new Medicare price inflation rebates.
Decision is a win for the Pharmaceutical Research and Manufacturers of America in lawsuit against the US Health and Human Services Department.
The regulatory provisions being challenged are part of a Trump-era “midnight rule” that could be changed by the Biden Administration before implementation, but PhRMA is not taking any chances about the future of copay assistance programs.