HRSA has purportedly reversed its stance on allowing newly established HOPDs, not yet on hospitals’ Medicare Cost Reports, to be eligible for 340B drug pricing. Commensurate with the end of the Coronavirus Public Health Emergency (PHE), HOPD sites that are not listed as a reimbursable facility on the hospital’s most recent Medicare cost report and not listed on the OPAIS website, will not be considered an eligible location. While HRSA has not yet released public-facing guidance on the issue, the agency moved the June 2020 FAQ allowing patients of unregistered outpatient facilities to be eligible for 340B drug pricing to the COVID-19 Resource section of the website and has reported the change to several national 340B Advocacy groups.
Accordingly, the new standard go-live policies for 340B will revert to the following. All current child sites operating under the immediate eligibility rules :
In March and June 2020, HRSA issued FAQ guidance allowing newly established hospital outpatient departments (HOPDs) to be considered 340B-eligible. HRSA’s March 2020 guidance indicated that patients in newly established HOPD facilities may still be eligible to receive 340B drugs to the extent that they are patients of the covered entity. Further, HRSA’s June 2020 FAQ update indicated that while hospitals could not register newly established HOPD facilities as offsite outpatient facilities, patients in those facilities were still eligible to receive 340B drugs. HOPDs were not required to wait until the Quarterly Enrollment Period and following effective date to be able to utilize drugs at the newly established sites.
Collectively, guidance did not require HOPDs to list newly established sites on its Medicare Cost Report to be considered eligible for 340B pricing. As a result, many covered entities were able to recognize up to 18+ months of additional savings. Because HRSA’s guidance did not reference the PHE as a driver for FAQ updates, HRSA’s change in guidance was accepted as permanent.
With just days before the PHE ends, HRSA has now indicated that the agency intends to return to a “pre-COVID policy regarding registration of outpatient facilities” and now requires outpatient facility sites to be registered as child sites in OPAIS for patients seen at those sites to be eligible for 340B drugs. In a non-public statement, HRSA confirmed that the hospital should halt purchase and use of 340B drugs at the non-listed HOPDs following the May 11th end date. HRSA has confirmed that accumulations incurred during the PHE can be carried over, however.
While HRSA has not released public-facing guidance on the issue, the agency moved the June 2020 FAQ allowing patients of unregistered outpatient facilities to be eligible for 340B drug pricing to the COVID-19 Resource section of the website.
Given HRSA’s recent change in stance on eligibility, Advis recommends that Covered entities begin preparing to take the following steps to remain in compliance with HRSA policy:
Un-map the previously eligible locations in billing software and inventory management systems until they are registered as child sites in OPAIS.
Update the covered entities policies and procedures to reflect any changes
Now that the unregistered child sites are ineligible until registration, consider establishing Group Purchasing Organization Accounts for these locations until they can be registered.
Advis will continue to follow this important update and offer additional guidance as it becomes available. For any questions regarding this update, or for organizational assistance with any other healthcare regulatory or operational matter, please contact an Advis expert or call 708.478.7030.