Topic
340B
257 published works
Health Industry Washington Watch
HRSA Issues 340B Drug Discount Program Civil Money Penalty Proposed Rule
On June 17, 2015, the Health Resources and Services Administration (HRSA) issued a proposed rule to implement civil money penalty (CMP) provisions added to section 340B of the Public Health…
Inside Government Contracts
HRSA Proposes Calculation of 340B Ceiling Prices, Implementation of Manufacturer Civil Monetary Penalties
On June 17, 2015, the Health Resources and Services Administration (HRSA) published a proposed rule to clarify how manufacturers should calculate the ceiling price for covered outpatient drugs under the…
To Be or Not to 340B Blog
Finally! HRSA Proposes Manufacturer Civil Monetary Penalties
By Alyce Katayama, Elizabeth Gebarski
On June 17, 2015 the Health Resources and Services Administration ("HRSA") finally published its much anticipated proposed rule, the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties…
To Be or Not to 340B Blog
Near Miss on Congressional Overhaul of 340B Program
By Alyce Katayama, Elizabeth Gebarski
In just a matter of days, changes to the 340B Program were proposed and then withdrawn from H.R. 6, The 21st Century Cures Act. Had hospitals, health systems, and related lobbying groups not been closely watching the Act,…
Health Care and Life Sciences
House Energy and Commerce Committee Proposes, then Drops, 340B Reform Language to 21st Century Cures Legislation
By Alan J. Arville, Constance A. Wilkinson, Selena M. Brady
By Alan J. Arville, Constance A. Wilkinson and Selena M. Brady The House of Representatives Energy and Commerce Committee ("the Committee") circulated draft language to include in its 21st Century…
To Be or Not to 340B Blog
How Much Will You Pay for an Inaccurate 340B Ceiling Price?
By Alyce Katayama, Elizabeth Gebarski
Under the authority granted it by the Patient Protection and Affordable Care Act, the Health Resources and Services Administration (HRSA) is moving forward to laying the groundwork for imposing civil…
Triage Health Law
Resurrection of the 340B Mega Rule
In November 2014, we provided an update, which noted that the Health Resources and Services Administration (HRSA) had halted publication of the 340B Mega Rule. HRSA, however, has now resurrected…
To Be or Not to 340B Blog
Key Dates Approaching for Title X Family Planning Grantees in the 340B Program
By Alyce Katayama, Elizabeth Gebarski
Mark your calendars! Calling all Title X Family Planning clinics that participate in the 340B Program—recertification opens May 13, 2015 and that means 340B Participant Change Forms must be submitted…
Health Industry Washington Watch
OMB Reviewing New HRSA 340B Omnibus Guidelines
Today the Health Resources and Services Administration (HRSA) officially requested White House Office of Management and Budget (OMB) review of new “omnibus guidelines” on the 340B drug discount program. While…
Health Care and Life Sciences
Members of House Subcommittee Express Support for the 340B Program, but Need for Clarity, Oversight and Transparency
By Selena M. Brady, Alan J. Arville
On March 24, 2015, the House of Representatives Energy and Commerce Health Subcommittee[1] (the "Subcommittee") held a 340B Program hearing with testimony from the Deputy Administrator of Health Resources and…