Category: Regulatory

Louisiana and Mississippi health care providers eligible to participate in the 340B program may enroll immediately rather than having to wait until the next quarterly registration period Oct. 1 through 15, the U.S. Health Resources and Services Administration (HRSA) announced

Michelle Herzog, long-time second-in-command at the U.S Health Resources and Services Administration’s Office of Pharmacy Affairs (OPA), has taken charge as OPA director on an acting basis.

A HRSA spokesperson confirmed yesterday morning that Herzog will oversee OPA temporarily now

The Biden administration plans to rescind a published but unimplemented Trump-era regulation that would peg Medicare Part B drug reimbursement for 50 expensive, physician-administered drugs on the lowest price that drug manufacturers get in similar countries. The widely criticized regulation

UPDATE Tuesday, July 27, 2021, 1:45 p.m. Eastern—Drug manufacturer Novartis provided the following statement:

“Novartis recently notified the Health Resources and Services Administration (HRSA) that we inadvertently neglected to offer the 340B ceiling price to covered entity types added by

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 (OPA), gave a brief update on the 340B program during yesterday’s 340B Coalition virtual summer conference. She explained that “due to current

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.

In

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