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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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.
Chiquita Brooks-LaSure’s nomination was approved in a 55-44 vote, with five Republicans joining Democrats in favor. Her confirmation clears the way for other appointments to key positions at the agency, such as the directors of the centers for Medicare and Medicaid.
Tactic aims to allow incoming Administration to scrutinize so-called ‘midnight rules’ issued in the final days of the Trump Administration before they take effect. Regulators may also solicit stakeholder comments on delayed rules.