Remedy for the 340B-Acquired Drug Payment Policy Final Rule Summary

CMS released a final rule (CMS-1793-F) on November 2, 2023, that describes the agency’s actions to craft a remedy relating to the adjustment of Medicare payment rates for drugs acquired under the 340B Program from calendar year 2018 through September 27, 2022, following a remand from the United States District Court for the District of Columbia and the United States Supreme Court’s decision in American Hospital Association v. Becerra. The final rule was published in the November 8, 2023, issue of the Federal Register. CMS is adopting the following final rule policies:

• Repay 340B hospitals for money owed from January 1, 2018, through September 27, 2022, through a lump sum payment less amounts already paid through claims reprocessing that occurred for services furnished between January 1, 2022, through September 27, 2022.
• Provide the repayment amount to hospitals inclusive of any additional beneficiary coinsurance and not allowing hospitals to collect additional coinsurance.
• Maintain budget neutrality for these additional payments to 340B hospitals through a -0.5 percentage point adjustment to the annual outpatient prospective payment system (OPPS) update that applies to non-drug OPPS services beginning January 1, 2026, until such time as the full amount of the additional payment is recouped (currently estimated at 16 years).