Ashley Ifeadike

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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 to adopt stakeholder suggestions...more

7/5/2023 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Inflation Reduction Act (IRA) , Medicare , Medicare Part D , Popular , Prescription Drugs

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 Act (IRA) on August 16, 2022. The Drug...more

3/20/2023 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Food and Drug Administration (FDA) , Inflation Reduction Act (IRA) , Medicare , Medicare Part D , Pharmaceutical Industry , Prescription Drugs

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)....more

1/6/2023 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Health Care Providers , Medicare , Medicare Part B , OIG

340B Program: HRSA Proposes to Modify Administrative Dispute Resolution Process

On November 30, 2022, the Health Resources and Services Administration (HRSA) published a proposed rule (Proposed Rule) in the Federal Register that proposes to introduce several changes to the current administrative dispute...more

12/6/2022 / Administrative Review Board , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Dispute Resolution , HRSA , Prescription Drugs , Section 340B

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