In 2018, the U.S. Department of Health & Human Services (HHS) implemented a reduction to reimbursement payments for 340B drugs under the Outpatient Prospective Payment System (OPPS) Rule. This lowered the reimbursement rate from the average sales price (ASP) plus 6% to ASP minus 22.5%. In June 2022, the U.S. Supreme Court vacated the 2018 and 2019 rule and remanded the case back to the federal district court to determine remediation. U.S. District Court Judge Rudolph Contreras ruled to provide hospitals prospective relief by restoring the reimbursement rate for the remainder of the year on September 28, 2022. There has yet to be a ruling on the second motion filed by hospital groups seeking to remedy underpayments to 340B hospitals in OPPS Rules 2018-2022.
CMS has announced the final OPPS Rule for 2023, confirming that reimbursement would be restored to ASP plus 6% for the calendar year. CMS will continue to require the appropriate modifiers “JG” or “TB” to be applied to 340B claims for informational purposes. In addition to the final rule, the agency announced it “will address the remedy for 340B drug payments from 2018-2022 in future rulemaking prior to the CY 2024 OPPS/ASC proposed rule.”
Some Medicare Administrative Contractors (MACs) have announced that claims prior to September 28, 2022, may be reprocessed as ASP plus 6%. However, CMS has not announced an official remedy for the calendar year 2022. It is advised that entities reach out to their specific MAC regarding the process for timely submission for adjustments to impacted claims. Hospitals should review repayment instructions by MAC and also discuss repayment requirements with MAC. Hospitals also should monitor payments on or after September 28, 2022. They should seek MAC repayments for January 1, 2022 to September 27, 2022 and note that timely filing limits apply. Hospitals should assess Medicare Advantage plans for repayments and future contract terms for reimbursement. Some Medicare Advantage plans have reprocessed claims while others have not acknowledged the change.
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