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…

Indiana General Assembly passes landmark 340B anti-discrimination bill (HB 1405)

On April 22, 2021, the Indiana General Assembly passed a bill (HB 1405) that protects Indiana 340B safety-net providers from discriminatory and predatory practices by pharmacy benefit managers (PBMs).  HB 1405 is expected to be signed into law by the governor of Indiana, Eric J. Holcomb, next week and without objection.  HB 1405 prohibits a contract between…

United Therapeutics Announces Details on Phase Two of its Restrict Contract Pharmacy Policy

By letter dated April 12, drug manufacturer United Therapeutics (UT) announced additional details regarding the second phase of its restrictive contract pharmacy policy.  UT initially sent letters to covered entities in November 2020 notifying them that UT would be implementing a new contract pharmacy policy in two phases.  Under the first phase, UT stated that it will deny all…