Federal 340B program officials confirmed last week that providers granted immediate 340B enrollment under a COVID-19 public health emergency flexibility are not losing their 340B eligibility and will not need to re-enroll now that the PHE is over.
The U.S. Health Resources and Services Administration unnerved some program stakeholders this month when it added the language below to the Office of Pharmacy Affairs homepage:
Supplemental Medicaid Exclusion File for immediate registrations
HRSA’s supplemental Medicaid Exclusion File (MEF) (XLSX – 217 KB) includes a list of entities that have been approved for immediate enrollment and will be posted through June 9, 2023. This list is in addition to the quarterly MEF posted on the 340B Office of Pharmacy Affairs Information System.
It was tacked to the end of the notice HRSA added to the OPA homepage on May 11 that the PHE was ending that day and, “as such, the specific COVID-19 PHE flexibilities allowed under the 340B Program will expire on May 11, 2023.”
Early during the pandemic, HRSA announced it would let some providers, upon request and review, enroll in 340B immediately as a pandemic-response measure. It began posting a “supplemental Medicaid exclusion file” every Friday in addition to its normal Medicaid exclusion file that it posts every calendar quarter on the 340B program database 340B OPAIS.
HRSA’s statement on the OPA homepage that it would post the supplemental Medicaid exclusion file “through June 9, 2023” caused at least one long-time 340B program veteran to question if HRSA was saying that entities let into 340B immediately under the COVID-19 flexibility were losing their eligibility effective June 9 and would have to re-enroll. The question arose in the context of HRSA’s controversial reversal of its policy that it announced during the pandemic that for hospitals unable to register outpatient facilities in 340B because they are not yet on the hospital’s most recently filed Medicare cost report, “the patients of the new site may still be 340B eligible to the extent that they are patients of the covered entity.”
340B Report asked HRSA on May 15 if entities that were granted immediate 340B enrollment under its COVID-19 flexibilities will lose their 340B eligibility and need to register again to participate.
“No, these entities will not lose 340B eligibility,” a HRSA spokesperson said May 16. “After June 9th, all entities will appear on the regular quarterly MEF posted.”