FDA REVOKESEVUSHELD EMERGENCY USEAUTHORIZATION (EUA)

On January 26, 2023, the Federal Drug Administration (FDA) added AstraZenica?s Evusheld (tixagevimab and cilgavimab) to the list of drugs no longer authorized under an EUA in the United States. Previously Evusheld was approved as a pre-exposure option for individuals with moderate to severe immunocompromised systems or for whom COVID-19 vaccinations were not recommended The FDA states this monoclonal antibody therapy is ineffective with several omicron subvariants, includingBQ.1, BQ.1.1, BF.7, BF.11, BA.5.2.6, BA.4.6, BA.2.75.2, XBB, and XBB.1.5.1 .

The letter issued from the FDA to AstraZeneca is available through the following download: https://www fda gov/media/154704/download

Facilities seeking to recover underpayments made by Medicare due to unlawfully reduced OPPSreimbursement for drugs purchased under the Health Resource Service Agency?s 340B program between 2018 and September 28, 2022, will have to wait until this fall to learn exactly how and when CMSplans to remedy that financial shortfall

By some estimates, nearly $10 billion dollars of underpayments are at stake Drugs purchased under the 340B program are reported with modifier JG on outpatient facility claims

PARA Dat a Edit or users can identify 340B discounted payments from Medicare by searching the CMStab for outpatient claims reporting modifier JG:

CMSasserts that due to budget neutrality requirements, it is unable to immediately remit payment to correct years of prior claims processing. The agency has promised to publish a proposed remedy prior to the publication of the 2024 OPPSProposed Rule, which is typically released in early summer. The final decision on repayment methodology should be released in the fall of 2023, commensurate with the release of Medicare?s 2024 OPPSFinal Rule

Dissatisfied with the delay in resolution, the American Hospital Association filed a motion with the United States District Court for the District of Columbia to require immediate repayment to the affected providers, claiming that this was the only appropriate solution to resolve the underpayments That motion was denied on January 10, 2023 The court?s decision included the following key excerpts:

?Plaintiffs argue that the Supreme Court?s holding in Becerra ?dictates a single possible remedy?: ?repaying those hospitals that were unlawfully underpaid, from 2018 to the present, the difference between what they were paid and ASP plus 6%.?? And this Court has already identified several potential remedies that the parties previously put on the table ? Thus, the Court is puzzled by Plaintiffs?attempt to now characterize the remedial path as providing just one option, and it fails to see what exactly that option is.

?To the extent Plaintiffs seek an order commanding HHSto repay each underpaid claim to the penny, that cannot possibly be the only rational choice available to the agency.As Plaintiffs readily acknowledge, HHScould seek to implement a remedy such as a prospective one-time rate increase that avoids calculating individual claims ?

?Although the Court declines to retain jurisdiction, it expects that HHSwill act promptly to remediate its underpayments ?

The AHA issued a press release which reported the court decision at the following link: https://www.aha.org/news/headline/2023-01-10-district-court-remands-case-hhs-determineremedy-340b-underpayments

?The U S District Court for the District of Columbia today decided to allow the Department of Health and Human Services to propose an appropriate remedy for its past underpayments to hospitals participating in the 340B drug pricing program. ? In the outpatient prospective payment system final rule for calendar year 2023, the agency said it would defer any proposal of a remedy for CYs 2018-2021 until sometime before its CY2024 payment rule, and in subsequent legal filings, the agency stated that it intends to announce a final remedy before the 2024 OPPSrulemaking cycle is complete next fall.

?In a statement shared with the media today, AHA General Counsel Melinda Hatton said, ?For more than five years, the Department of Health and Human Services has unlawfully withheld vital funding from 340B hospitals that helps them provide a range of important benefits to their patients and communities.

"We are disappointed that the district court elected to extend this delay by remanding this case back to the department to determine the appropriate remedy. HHSrecently indicated that it expects to propose a remedy by April, and like the district court said in its opinion, the AHA ?expects that HHSwill act promptly to remediate its underpayments ?We look forward to continuing to work with the Administration to develop a plan to swiftly repay 340B hospitals, with interest, while ensuring the remainder of the hospital field is not penalized as they too continue to serve and care for their patients and communities.?

As a result of legal action taken by the AHA, the District Court previously ordered Medicare to stop applying the unlawful 340B discounts on claims processed on or after September 28, 2022. Medicare announced its compliance with that directive in its ?MLN Connects?edition dated October 13, 2022: https://www.cms.gov/outreach-and-educationoutreachffsprovpartprogprovider-partnershipemail-archive/2022-10-13-mlnc# Toc116466499