Category: Regulatory

The U.S. Health Resources and Services Administration (HRSA) has posted drug manufacturer Novartis’ public notice to certain 340B hospitals that they might be eligible for refunds for overcharges on the company’s second-best selling drug—but only if the purchases comport with …

Hospitals groups were deeply disappointed last week with the U.S. Centers for Medicare & Medicaid Services’ (CMS) proposal to continue a nearly 30% cut in Medicare Part B reimbursement for hospitals’ 340B purchased drugs in place since 2018. Another provision …

Rear Adm. Krista Pedley, Director of the U.S. Health Resources and Services Administration’s (HRSA) Office of Pharmacy Affairs, gave a brief update on the 340B program during yesterday’s 340B Coalition virtual summer conference. She explained that “due to current litigation …

U.S. Health and Human Services (HHS) Secretary Xavier Becerra on Monday extended the COVID-19 national public health emergency (PHE) for another 90 days, to Oct. 17. The move extends 340B program flexibilities implemented during the pandemic’s early days. …

The recertification period for hospitals to continue to participate in the 340B program begins in mid-August. The U.S. Health Resources Services Administration (HRSA) has scheduled an informational webinar on Wednesday, Aug. 11 at 1 p.m. Eastern time to discuss the …

Several groups whose members or clients include 340B hospitals yesterday slammed the Biden administration’s decision to continue the Trump administration’s huge cut in Medicare Part B reimbursement for hospitals’ 340B purchased drugs. The American Hospital Association (AHA) has not, so …

Roughly one out of four 340B disproportionate share (DSH) hospitals could lose their eligibility for 340B drug discounts due to COVID-19 pandemic-related changes in patient mix, an analysis of hospital Medicare cost reports for 2019 and 2020 shows. About one …

There are signs that the U.S. Health Resources and Services Administration (HRSA) reorganization announced in late January is finally in motion. It is still unknown, though, if the 340B program is moving to a new home in the HRSA administrator’s …

340B trade associations and covered entities submitted public comments overwhelmingly supporting the Biden administration’s proposal to rescind a Trump-era rule requiring community health centers to pass along savings on insulin and injectable epinephrine to low-income patients. Drug manufacturer Eli Lilly, …