In a significant reversal of course, on Thursday, July 11, the White House announced that it was withdrawing a proposed rule by the Department of Health and Human Services’ Office…
On July 5, 2019, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) released a report which found that the Medicare program lost out on over…
On July 8, 2019, RWC-340B submitted a comment letter in response to the HRSA Information Collection Request (ICR) published in the Federal Register on May 9, 2019. In the ICR,…
On June 18, 2019, HRSA issued an information collection request (ICR) regarding the guidelines for manufacturer audits of 340B covered entities and the OPA informal dispute resolution process to resolve…
On June 14, 2019, RWC-340B submitted a letter to Captain Krista Pedley, director of the Office of Pharmacy Affairs, contesting HRSA’s multisite registration policy that will adversely affect the registration,…
On Thursday May 9, 2019 the House Energy and Commerce Committee, Health Subcommittee held a hearing on Lowering Prescription Drug Prices: Deconstructing the Drug Supply Chain. In the latter half…
Earlier today, HHS issued a Final Rule that will require pharmaceutical manufacturers to disclose the wholesale acquisition cost (“WAC”) in direct-to-consumer TV advertisements for all Medicare and Medicaid covered drugs. …
On May 6, 2019, the U.S. District Court for the District of Columbia ruled that CMS acted outside its statutory authority in adopting an almost 30% reimbursement cut for Medicare…
The Office of Pharmacy Affairs (OPA) recently published an update regarding the 340B ceiling price website. The update announces that HRSA will publish additional pricing data elements in the OPAIS…
A report prepared for 340B Health and published by L&M Policy Research shows that 340B hospitals care for a greater proportion of the underserved and low-income patient population than non-340B…