Indiana District Court Holds Important Hearing on HRSA’s Enforcement and Eli Lilly’s 340B Price Restrictions

On July 30, the U.S. District Court for the Southern District of Indiana held oral arguments in the case, Eli Lilly et al. v. Becerra et al., regarding the May 17 enforcement letter (“May 17 Letter”) that HRSA sent to Eli Lilly and other drug manufacturers informing them of HRSA’s formal determination that their actions to…

House of Representatives Approves Spanberger-McKinley Amendment Supporting HRSA Action Against Drug Manufacturer

On July 27, the U.S. House of Representatives approved an amendment to the House Appropriations Labor, Health and Human Services legislation that supports agency action against manufacturers that are not honoring contract pharmacy arrangements.  The amendment was approved as part of a funding package for the next fiscal year for many federal departments, including HHS.  The…

On July 11, the U.S. House Appropriations Committee emphasizes the importance of the 340B program in HHS report

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 Agencies.  The accompanying report calls for HRSA to report on actions it is taking to (1) safeguard safety-net providers’ access to discounted drugs, including those dispensed at contract pharmacies, and…

Secretary of Health and Human Services (HHS) appoints of the much-awaited 340B Alternative Dispute Resolution (ADR) Board

340B Safety net providers laud the Secretary of Health and Human Services’ (HHS) appointment of the much-awaited 340B Alternative Dispute Resolution (ADR) Board on June 21, 2021.  Members of the ADR Board will serve as ADR Panelists to resolve disputes between 340B safety-net providers and drug companies. Beginning in the summer of 2020, several drug manufacturers have…

Secretary Becerra Provides Important Insight on 340B at the U.S. Senate Appropriations Sub-Committee

On June 9, 2021, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra appeared before the U.S. Senate Appropriations subcommittee.  In his testimony, Secretary Becerra provided important insight into HHS’s stance regarding six drug companies’ unilateral actions to halt 340B pricing on drugs shipped to contract pharmacies.  Senator Manchin stated his interest in…

White House Budget Office Approves Plan to Rescind Controversial Trump-Era Insulin Rule

Earlier this week, the White House Office of Management and Budget (OMB) completed its review of HHS’ proposal to rescind the Trump Administration’s final rule that would require federally qualified health centers (FQHCs) to provide insulin and injectable epinephrine to low-income patients at the price the FQHC pays for those drugs under the 340B program.…

Tennessee Governor Enacts Law to Protect 340B Covered Entities from Discriminatory Reimbursement Practices

Last week, Tennessee Governor Bill Lee signed into a law a bill that will protect 340B covered entities and their contract pharmacies from discriminatory reimbursement practices commonly employed by pharmacy benefit managers (PBMs) and third party payers and will help to bring pricing transparency to Tennessee’s healthcare system (HB 1398/SB 1617).    The law prohibits…

HRSA Determines Six Manufacturers’ Contract Pharmacy Policies Violate 340B Statute

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 340B pricing at contract pharmacies “have resulted in overcharges and are in direct violation of the 340B statute.”  As a result, HRSA is requiring the six manufacturers…

340B providers filed an amicus brief in opposition to AstraZeneca’s motion to invalidate Advisory Opinion.

On May 4, 2021, 340B safety-net providers and their trade associations filed a brief in the case brought by AstraZeneca Pharmaceuticals LP (AstraZeneca) against the U.S. Department of Health and Human Services (HHS) seeking to invalidate the former HHS General Counsel’s 2020 Advisory Opinion on contract pharmacy arrangements.  The brief was filed jointly with the…

Arkansas Passes Comprehensive 340B Anti-Discriminatory Reimbursement Bill, Protects Covered Entities Rights to Use Contract Pharmacies

Last week, Arkansas passed legislation (HB 1881) intended to address 340B discriminatory pricing practices by third party payers and pharmacy benefit managers (PBMs).  The law also addresses drug manufacturers denying access to 340B pricing at contract pharmacies.  The bill has been sent to Governor Asa Hutchinson for his signature.   The “340B Drug Pricing Nondiscrimination…