Following a favorable May 17 Letter (the “Letter”) issued by HHS requiring six drug companies to restart 340B pricing on drugs shipped to contract pharmacies or risk civil monetary penalties,…
Yesterday, HRSA Acting Administrator Diana Espinosa sent letters to Eli Lilly, AstraZeneca, Novartis, Novo Nordisk, Sanofi, and United Therapeutics making clear to the manufacturers that their restrictions on access to…
Representative Spanberger issued a press release yesterday announcing that she and 225 of her colleagues sent a letter to Acting HHS Secretary Norris Cochran, asking HHS to take immediate action…
Washington, D.C. – On November 23, 2020, Ryan White Clinics for 340B Access (RWC-340B) and five 340B providers filed a motion in the United States District Court for the District…
On October 9, 2020, RWC-340B and two of its member 340B grantee clinics, Cempa Community Cares and Matthew 25 AIDS Services, Inc., filed a lawsuit in the United States District…
Today, RWC-340B submitted to a letter to Secretary of the U.S. Department of Health and Human Services (HHS) Alex Azar requesting that HHS initiate enforcement actions, in the form of…
On Friday, July 24, President Donald Trump signed four Executive Orders designed to lower the cost of prescription drugs. This alert will focus on three Orders that could impact 340B…
On April 2, the Food and Drug Administration (FDA) announced that, effective immediately, it is modifying its current policy to shorten the abstinence period, from 12 months to 3 months,…
The Centers for Medicare & Medicaid Services (CMS) released a toolkit on Medicare payments to providers of telehealth and telemedicine services on Friday, March 20. The toolkits give further information…
HRSA/OPA Guidance in Response to COVID-19 Late yesterday, HRSA/OPA updated its website to include guidance addressing the COVID-19 pandemic. The guidance states: Case-by-Case Waivers – OPA is reviewing on a…