The Rebate Debate and Other “Fast and Furious” 340B Developments

340B lately has had a news cycle that seems to change by the hour, and 340B Health President and CEO Maureen Testoni joins us to break down some of the biggest news happening in Washington, D.C., and in courthouses around the country.

HRSA Seeks Feedback on Reviving Rebates 

After courts halted the rebate pilot that was set to go into effect in January, Maureen notes that the Health Resources & Services Administration is seeking more information on a possible revival of its rebate plans. Hospitals are responding with their objections, as are lawmakers on Capitol Hill. Nearly 100 members of the House of Representatives wrote a letter to the committee in charge of funding HRSA urging it to block federal spending for any HRSA rebate model.

Huge Rulings on the GPO Prohibition, Child Site Registration

The past several months have seen big 340B rulings from federal courts. One decision vacated HRSA guidance that had blocked certain 340B hospitals’ use of GPOs for their initial drug inventory, finding that HRSA failed to properly explain the reasons for that restriction. The other decision found that HRSA similarly failed to explain a rationale for restricting 340B eligibility for child sites for up to 23 months after the sites come online. Maureen notes that HRSA could appeal the rulings or seek to issue new guidance.

Federal Government Weighs in on State Contract Pharmacy Lawsuits

For the first time, the federal government has filed briefs in support of drug companies in several lawsuits over state contract pharmacy protection laws. In these briefs, Maureen says the government effectively is telling judges it does not believe states have the right to protect contract pharmacy because federal 340B law preempts such actions. With the federal government weighing in on the matter and a recent split among appeals courts over the issue of preemption, it is possible this issue might be appealed at some point to the U.S. Supreme Court.

Resources

1. Use Our Letter Template Today To Oppose Development of a New 340B Rebate Program
2. Nearly 100 Members of Congress Urge Funding Block for 340B Rebate Model
3. Please Help Advocate for Enforcement Actions Against Drugmakers’ In-House Claims Data Demands
4. Federal Court Vacates HRSA’s 2013 GPO Prohibition Policy
5. Federal Court Decides HRSA Child Site Eligibility Restrictions Are Unlawful
6. Federal Government Backs Drug Companies in Litigation Over State Contract Pharmacy Laws
7. Appeals Court Blocks West Virginia 340B Contract Pharmacy Law, Creating Potential Split with Other Circuits
8. 340B Health Impact Profile Guidebook and Template