On Friday, July 9, Reps. David B. McKinley (R-WV) and Abigail Spanberger (D-VA) introduced the Preserving Rules Ordered for the Entities Covered Through (PROTECT) 340B Act (H.R. 4390), which seeks…
On June 23, 2021, drug manufacturer United Therapeutics (UT) filed a lawsuit in the U.S. District Court for the District of Columbia against HHS, alleging that HHS’s policy on contract…
The following press release was posted on Rep. David B. McKinley’s (R-WV-1) website on May 19, 2021. The press release can be accessed by clicking HERE. WASHINGTON – Today, Reps. David…
PRESS STATEMENT: FOR IMMEDIATE RELEASE Contact: Peggy.Tighe@PowersLaw.com July 9, 2021: RWC-340B, a national association of Ryan White HIV clinics, enthusiastically supports introduction of the PROTECT Act by Representatives McKinley (R-WV)…
The Supreme Court has agreed to review three cases in its next term that have potential impact on 340B covered entities. First, the Supreme Court will review AHA, et al.…
By letter dated June 30, 2021, drug manufacturer Boehringer Ingelheim Pharmaceuticals, Inc. notified covered entities that it will no longer honor all 340B contract pharmacy arrangements, effective August 1, 2021. …
As expected, on June 21, the Secretary of HHS appointed Alternative Dispute Resolution (ADR) Board members. ADR Board members are government representatives (not private stakeholders) from three government agencies: HHS…
The Powers team was informed today that the Secretary of HHS has signed a memorandum appointing members to the 340B Alternative Dispute Resolution Board (ADR Board). Appointment of ADR Board…
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…