The announced Centers for Medicare & Medicaid Services Price Negotiations for Medicare Part D drugs introduces a fundamental change for the process of drug pricing related to Medicare. The Inflation Reduction Act drug price negotiation program is designed to reduce the high costs of prescription medications by authorizing Medicare to negotiate directly with drug manufacturers and offers guidance as to how CMS will reach a maximum fair price on the selected drugs.

The implications for the new initiative go far beyond the 10 drugs that CMS will select as their first program participants. The action is expected to significantly impact same-class drugs’ pricing and profitability as well. It is also an ongoing plan for drug price negotiation. The first CMS list of selected drugs will be released on 1 September 2023. 

The first guidance document for the price negotiations was released on 15 March 2023. Revised Guidance was issued by CMS on 30 June 2023.