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 23, Senators Lamar Alexander (R-Tenn.) and Patty Murray (D-Wash.), the chair and ranking Democrat of the Health, Education, Labor and Pensions (“HELP”) Committee released bipartisan discussion draft…
The 340B annual recertification period for STD, TB and Title X grantees started on May 13, 2019 and ends on June 10, 2019. Recertification must be completed through the 340B…
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…
HRSA announced changes to the 2019 Ryan White HIV/AIDS Program Services Report (RSR) to require data on patients whose services are funded through Ryan White HIV/AIDS Program (RWHAP) program income…