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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 ...

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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...

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CMS Issues Revised Medicare Part B and Part D Inflation Rebate Guidance

On December 14, 2023, the Centers for Medicare & Medicaid Services (CMS) published two “revised” guidance documents implementing the Medicare Part B and Part D inflation...

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The Genesis case: The beginning of the end of HRSA’s “patient” definition?

On November 3, 2023, the U.S. District Court for the District of South Carolina issued a decision granting in large part Genesis Health Care’s (Genesis’s) motion for summary...

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CMS Issues Final Guidance on the Inflation Reduction Act (IRA) Drug Price Negotiation Program

On July 3, 2023, the Centers for Medicare & Medicaid Services (CMS) issued its final guidance on the Drug Price Negotiation Program established by the IRA. CMS showed some willingness...

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CMS Proposes Significant Changes to Medicaid Drug Rebate Program

On May 23, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled Misclassification of Drugs, Program Administration and Program Integrity Updates...

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CMS issues initial guidance on Drug Price Negotiation Program

On March 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued initial guidance on the Drug Price Negotiation Program, which was established under the Inflation Reduction...

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CMS issues Medicare Part B and Part D inflation rebate guidance

On February 9, 2023, the Centers for Medicare & Medicaid Services (CMS) published two “initial” guidance documents implementing the Medicare Part B and Part D inflation...

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HHS OIG issues ASP reports exploring need for guidance and increased oversight in ASP reporting

On January 3, 2023, the Department of Health and Human Services Office of Inspector General (OIG) publicly released two reports with respect to Medicare Part B average sales price (ASP).Fi...

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