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CMS issues Final Rule adopting some but not all proposed changes to the Medicaid Drug Rebate Program

On September 20, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled: Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program....more

HRSA Issues 340B Program final rule modifying administrative dispute resolution process

On April 19, 2024, the Health Resources and Services Administration (HRSA) published a final rule (Final Rule) in the Federal Register adopting several changes to the current administrative dispute resolution (ADR) process...more

CMS finalizes regulation specifying all covered prescriptions drugs are essential health benefits

On April 2, 2024, the Centers for Medicare & Medicaid Services (CMS) released the 2025 Notice of Benefit and Payment Parameters (NBPP) final rule (Final Rule), finalizing policies applicable to qualified health plans offered...more

Government declines to appeal ruling in PBM accumulator programs MDRP final rule litigation

On Tuesday, May 17, 2022, the U.S. District Court for the District of Columbia issued a decision granting the Pharmaceutical Research and Manufacturers of America’s (PhRMA)’s motion for summary judgment and vacating (i.e.,...more

D.C. District Court rules for PhRMA in PBM accumulator programs Final Rule litigation

On Tuesday, May 17, 2022, the U.S. District Court for the District of Columbia issued a decision granting the Pharmaceutical Research and Manufacturers of America’s (PhRMA)’s motion for summary judgment and vacating (i.e.,...more

MDRP: CMS issues Manufacturer Release on multiple best prices reporting option for VBPs

Last week, the Centers for Medicare & Medicaid Services (CMS) issued Manufacture Release 116, available here, which provides technical guidance to manufacturers on the multiple best prices (BPs) reporting option for...more

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