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In Proposed Rule, CMS Restores 340B Reimbursement and Seeks Comments on Remedying Past Unlawful 340B Cuts



July 19, 2022

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Legal Updates

On July 15, 2022, the Centers for Medicare and Medicaid Services (CMS) released its Hospital Outpatient Prospective Payment System (OPPS) Proposed Rule for calendar year (CY) 2023. Among other proposals, which are discussed by Husch Blackwell in a separate legal alert, CMS signaled that it intends to restore reimbursement for 340B drugs that have been unlawfully reduced since 2018. Reimbursement for 340B drugs will return to average sales price (ASP) plus 6% in the CY 2023 OPPS Final Rule. This Proposed Rule comes in response to the recent Supreme Court decision which ruled that HHS’s reimbursement cuts for 340B drugs to ASP minus 22.5% were unlawful. In order to maintain budget neutrality, CMS stated that it planned to offset the increased 340B reimbursement rates by decreasing the OPPS conversion factor. In doing so, all Medicare providers will be impacted rather than only safety-net providers.

Notably, CMS indicated that it is still evaluating how to rectify the unlawful 340B reimbursement cuts affecting cost years 2018-2022 and requested public comments on suggestions for remedies.

What this means for you

Husch Blackwell strongly urges 340B Covered Entities to submit public comments to CMS to influence how the historic 340B reimbursement cuts will be recouped. In addition, 340B Covered Entities should calculate the reimbursement they should have received had the reimbursement reductions never been implemented and consider submitting reimbursement appeals to CMS for calendar years 2018 – 2022. Our attorneys at Husch Blackwell are experienced in drafting and submitting public comments, in addition to analyzing and handling reimbursement appeals.

Contact us

For assistance with submitting public comments or any questions related to the 340B Drug Pricing Program, contact Daniel Avants, Amanda Bogle or your Husch Blackwell attorney.