Health, Pharmaceutical and Biotechnology Alert: HRSA issues letter discussing ADAP 340B rebates; proposed rule expected

On 3 February 2014, the Office of Pharmacy Affairs (OPA) posted a letter to its 340B drug pricing programme website discussing 340B rebates paid to AIDS drug assistance programmes (ADAPs). OPA is part of the Health Resources and Services Administration (HRSA) and administers the 340B programme. The letter, which is not dated, is signed by HRSA administrator Doctor Wakefield.

The Wakefield letter addresses the ability of ADAPs, a type of 340B-covered entity, to claim 340B rebates from manufacturers when the ADAP does not itself purchase the drug but rather covers some amount of insurance-related cost sharing for the drug, in the form of an insurance premium, copayment or deductible expenditure. Notably, this letter appears to be the first time that the 340B programme itself has addressed this issue.

ADAPs are the only type of covered entity that can access the 340B discount via a rebate, an option created by HRSA in 1998 through a notice in the federal register…

If you are registered and logged in to the site, click on the link below to read the rest of the Hogan Lovells briefing. If not, please register or sign in with your details below.

Sign in or Register to continue reading this article

Sign in


It's quick, easy and free!

It takes just 5 minutes to register. Answer a few simple questions and once completed you’ll have instant access.

Register now

Why register to The Lawyer


Industry insight

In-depth, expert analysis into the stories behind the headlines from our leading team of journalists.


Market intelligence

Identify the major players and business opportunities within a particular region through our series of free, special reports.


Email newsletters

Receive your pick of The Lawyer's daily and weekly email newsletters, tailored by practice area, region and job function.

More relevant to you

To continue providing the best analysis, insight and news across the legal market we are collecting some information about who you are, what you do and where you work to improve The Lawyer and make it more relevant to you.

Briefings from Hogan Lovells

View more briefings from Hogan Lovells

Analysis from The Lawyer

View more analysis from The Lawyer


Atlantic House
Holborn Viaduct

Turnover (£m): 1,098.00
No. of lawyers: 2,313 (UK 200)
Jurisdiction: UK
No. of offices: 8
No. of qualified lawyers: 219 (International 50)
No. of partners: 56