The U.S. Department of Health and Human Services (HHS) late last week extended the COVID-19 public health emergency (PHE) to mid-January, giving some 340B-eligible entities more time for immediate enrollment in the program without having to wait for the next calendar quarter, along with other 340B program flexibilities that HHS granted at the start of the pandemic.
In an Oct. 13 notice, HHS Secretary Xavier Becerra said he had extended the PHE for another 90 days “as a result of the continued consequences” of the COVID-19 pandemic. It was the 11th extension of the emergency first declared on Jan. 31, 2020.
The extension keeps in place until Jan. 13 the 340B program flexibilities granted to 340B providers by the U.S. Health Resources and Services Administration (HRSA) in March 2020. They include:
- Exempting 340B site registration requirements on a case-by-case basis.
- Allowing remote audits of covered entities, and in some cases, granting extra time to respond to audit deadlines.
- Allowing some hospitals not usually qualified to buy drugs though a group purchasing organization to purchase through a GPO if they cannot get the 340B price or wholesale acquisition cost price due to shortages and not requiring reporting of this information to HRSA.
A 340B flexibility that Congress granted expires at the end of this year.
A law enacted in March lets hospitals terminated from 340B during the pandemic because their Medicare disproportionate share (DSH) adjustment percentage fell below 340B statutory requirements as a consequence of the pandemic apply for readmission. The hospital must have been terminated from 340B during Medicare cost reporting periods ending no later than December 31, 2022.
HRSA made two of its program flexibilities—one on the use of telehealth and the other on use of 340B drugs in offsite outpatient facilities not yet listed as reimbursable on a hospital’s Medicare cost report—permanent in June 2020.
Groups that represent 340B covered entities want HRSA to clarify before the PHE ends if it will make any others permanent or seek public input on the issue.