Kalderos Sues HHS Over Contract Pharmacy Policy
On October 7, technology company Kalderos Inc. filed a lawsuit in the U.S. District Court for the District of Columbia against HHS alleging that HRSA’s contract pharmacy policy is unlawful. …
Fighting to Preserve the Benefits of the 340B Program
On October 7, technology company Kalderos Inc. filed a lawsuit in the U.S. District Court for the District of Columbia against HHS alleging that HRSA’s contract pharmacy policy is unlawful. …
The law firm representing United Therapeutics (UT), Latham & Watkins, has filed a request with HRSA to obtain a wide range of records related to HRSA’s enforcement of the 340B…
On September 23, U.S. Senator Mike Braun (R-IN) introduced a bill to amend the 340B statute to allow HHS to audit 340B covered entities to determine how they use “net…
Earlier today, HRSA sent letters to Eli Lilly, AstraZeneca, Novartis, Novo Nordisk, Sanofi, and United Therapeutics alerting them that the agency has notified the HHS-Office of the Inspector General (OIG),…
On July 19, HHS and the Departments of Labor and Treasury took an important step to remove insurance copayment requirements as a barrier to access to HIV preexposure prophylaxis (“PrEP”)…
On July 11, the U.S. House Appropriations Committee approved the fiscal year (FY) 2022 appropriations bill (the “Bill”) and accompanying report for the Department of Labor, HHS, Education, and Related…
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…
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,…