The Centers for Medicare & Medicaid Services (CMS) had released a final rule on November 2, 2023, which details how the agency plans to remedy underpayments from 2018 to 2022 for drugs acquired through the 340B Drug Pricing Program. The final rule will become effective 60 days after its publication in the Federal Register.
The provision of adequate compensation to 340B-covered entities has been a significant issue in healthcare law for the past few years. The 340B Drug Pricing Program, regulated by the Health Resources and Services Administration (HRSA), allows certain outpatient drug providers that care for a large number of underserved patient populations to purchase prescription drugs at significantly reduced prices. However, there have been widespread reports of underpayments related to drugs obtained through this program over the last few years.
The recent final rule released by the CMS is a strategic initiative towards providing thorough reimbursement for these underpayments. There isn’t a lot of specific detail available at the moment regarding the nuts and bolts of how these reimbursements will be processed. However, this rule is certainly a much-anticipated step in the right direction to serve and protect the financial health of 340B covered entities.
Further information about the rule can be had from the original article by Holland & Knight LLP provided at JD Supra.