With September 1 quickly approaching, all eyes are on the imminent developments that will shape the drug pricing landscape in 2023. President Joe Biden signed the Inflation Reduction Act into law, marking a notable milestone in drug pricing legislation. A key feature of the IRA is its authorization for Medicare to directly negotiate prices with manufacturers for specific high-expenditure Medicare drugs. CMS will announce the first 10 drugs selected for negotiation later this week by September 1, 2023 and first round of negotiations will occur during 2023 and 2024.
In March, CMS released initial guidance on the process for drug price negotiation that outlined how the agency would select drugs for negotiation. CMS also released revised program guidance in June that outlined how CMS will negotiate to reach agreement on a maximum fair price for a selected drug with participating manufacturers.