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…

Gilead Delays Harmful Changes to Patient Assistance Program Until January 1, 2022

Last week, Gilead issued a statement that it is delaying a change to its Advancing Access® Patient Assistance/Medication Assistance Program (PAP/MAP) until January 1, 2022. Gilead previously announced that, effective Oct. 1, 2021, pharmacies dispensing drugs to clients enrolled in the PAP/MAP would only be reimbursed for “the amount paid for each bottle plus a dispensing fee and an administrative…

New Research Shows 340B Hospitals Provide More Medication Access Services Than Non-340B Hospitals

Below is a press release issued by CV340B highlighting new research showing that 340B hospitals provide more medication access services than non-340B hospitals.  The research was performed by the University of Illinois Chicago and funded, in part, by CV340B. *** CV340B PRESS STATEMENT ON MEDICATION ASSISTANCE PROGRAM STUDY (D0942315)CV340B PRESS STATEMENT ON MEDICATION ASSISTANCE PROGRAM…

Bipartisan Group of Senators Reintroduce Bill to Protect Eligibility of 340B Hospitals During COVID-19 Pandemic

Last week, a bipartisan group of six senators, led by Senator John Thune (R-SD), reintroduced legislation (S. 773) that would allow disproportionate share hospital (DSH), children’s hospitals, and rural referral centers, or sole community hospitals to temporarily maintain 340B eligibility during the COVID-19 pandemic.  One of the requirements for these hospital types to participate in…

Indiana District Court Issues Order to Halt the 340B Administrative Dispute Resolution for Claims Against to Eli Lilly

On March 16, 2021, the U.S. District Court for the Southern District of Indiana issued an order granting Eli Lilly’s request for a preliminary injunction to halt the 340B Administrative Dispute Resolution Final Rule (ADR Rule).   The ADR Rule was issued to provide a binding and precedential way for 340B safety-net providers and manufacturers to…

HHS issues proposal to further delay the Trump Administration’s 340B insulin final rule

On March 9, 2021 the Department of Health and Human Services (HHS) issued a proposal to further delay implementation of 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. …

Express Scripts Issues 340B Claims Identification Requirements

Express Scripts, a large US-based PBM, announced a new 340B retrospective claims identification requirement.  The new policy may impose significant burdens on 340B pharmacies and threaten the viability of safety net providers. On February 24, Express Scripts, one of the largest pharmacy benefit managers (PBMs) in the United States, issued a notice stating that, beginning March 1, pharmacies…

226 Members of Congress Sign Letter Condemning Manufacturer Actions

In a letter, led by Representatives Spanberger, Axne, Matsui, McKinley, sent to Acting HHS Secretary Norris Cochran, 226 Members of Congress called on HHS to take immediate action against manufacturers that refuse to provide discounted drugs to community safety net providers and require manufacturers to reimburse community safety net providers for overcharges. The also called on HHS…