Topic
340B
257 published works
Health Law Update
OMB Reviewing HRSA Proposed Rule For Civil Monetary Penalties And Ceiling Price Regulations For 340B Drug Discount Program
By Lee H. Rosebush, Dena Kessler
The agency that oversees the 340B Drug Discount Program (340B program) is seeking review by the White House Office of Management and Budget (OMB) of a proposed rule that would…
Health Industry Washington Watch
HRSA Moving Ahead on 340B Program Enforcement Rule, Including Manufacturer CMPs for Overcharges to 340B Entities
The Health Resources and Services Administration (HRSA) is seeking White House review of its proposed rule to implement new Affordable Care Act 340B drug discount program enforcement authorities and pricing policies.…
To Be or Not to 340B Blog
340B Reform Legislation: Is Anything in the Offing?
As readers of this blog already know, manufacturers and some legislators believe the 340B program has grown too large, suffers from mission creep and needs reform. They argue that the…
Health Industry Washington Watch
Congressional Health Policy Hearings
Congressional committees have held several hearings this week on health policy issues. On March 24, the Energy and Commerce Health Subcommittee held a hearing on the 340B drug pricing program.…
Health Industry Washington Watch
Upcoming House Hearing on 340B Program (March 25)
The House Energy and Commerce Subcommittee on Health will hold a hearing on Thursday, March 5, 2015 on “Examining the 340B Drug Pricing Program,” focusing on the functionality of the…
Real Lawyers Have Blogs
Franchising, Construction, Intellectual Property and A Lot More: New Blogs Joining the LexBlog Network
Because of upgrades to the LexBlog publishing platform last week and the ensuing content freeze, we've got a bit of a two-fer this week with new publications from this week…
To Be or Not to 340B Blog
The Message Is Clear from OPA Director Pedley
Covered entities should be constantly preparing for audit. That was the message, loud and clear, from Office of Pharmacy Affairs Director, Cmdr. Krista Pedly, who spoke by webcast at the…
To Be or Not to 340B Blog
340B Covered Entities: What to Expect When OPA Comes Knocking
Now that OPA has ramped up its audit activities, covered entities should not be surprised to find themselves on the receiving end of a 340B program review conducted by HRSA/OPA. …
To Be or Not to 340B Blog
340B Program Participants: It’s Time to Ramp Up Compliance
340B covered entities need to revisit and perhaps ramp up their compliance efforts. The director of the Health Resources and Services Administration’s Office of Pharmacy Affairs has been very open…
To Be or Not to 340B Blog
340B and the OIG Work Plan
By Jaya White
OIG's recently issued FY 2015 Work Plan has made duplicate discounts a new focus for FY 2015. OIG "will assess the risk of duplicate discounts for 340B-purchased drugs paid through…