On Wednesday, November 8, 2017 the Federal Trade Commission (FTC) hosted a workshop seeking to explore the general question of why the cost of prescription drugs has risen greatly in recent history. The Workshop was framed...more
Earlier this month the House Energy and Commerce Committee’s subcommittee on Government Oversight and Investigations held its second hearing on the 340B Drug Discount Program. The hearing followed on the heels of a July 18th...more
On Wednesday, the United States District Court for the District of Columbia issued its highly anticipated opinion regarding the 340B orphan drug litigation. The Court ruled in favor of PhRMA, a trade association that...more
The Health Resources and Services Administration (HRSA) recently issued proposed omnibus guidance (Omnibus Guidance) interpreting various provisions of the 340B Drug Pricing Program (340B Program). The 340B Program allows...more
As noted in our previous client alert, the Health Resources and Services Administration (“HRSA”) released its highly anticipated proposed 340B Drug Pricing Program Omnibus Guidance (“Guidance”). The Guidance offers updated...more
On August 27, 2015, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), released the 340B Drug Pricing Program Omnibus Guidance (Guidance). Referred to...more
On Friday, August 28, 2015, the Health Resources and Services Administration (“HRSA” or “the Agency”) published in the Federal Register Notice of its proposed “omnibus” or “mega” guidance (“Proposed Guidance”) regarding...more
On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published proposed Omnibus Guidance (the “Proposed Guidance”) governing policies related to section 340B of the Public Health Service Act (“PHSA”),...more
After much anticipation, the Health Resources and Services Administration (HRSA) late last week released its 340B Drug Pricing Program Omnibus Guidance Proposal (the Proposal). HRSA indicates that its goal in issuing the...more
Last week, the Health Resources and Services Administration (HRSA), part of HHS, released proposed new guidance for covered entities enrolled in the 340B Drug Pricing Program, as well as drug manufacturers required to make...more
In August 27, 2015, the U.S. Department of Health and Human Services (HHS) released the long-awaited and much-anticipated proposed 340B Drug Pricing Program (340B Program) Omnibus Guidance (Proposed Guidance). The Proposed...more
CMS will begin to enforce what could be significant penalties on manufacturers who fail to report required data. The Centers for Medicare & Medicaid Services (CMS) has announced a short timeframe before detailed...more
On July 23, 2013, the U.S. Department of Health and Human Services Health Resources and Services Administration (HRSA) issued a long-anticipated Final Rule regarding the 340B Drug Pricing Program (340B Program) orphan drug...more
Following the recent release of new Program Notices regarding the Group Purchase Organization (GPO) prohibition and Medicaid Exclusion File, 340B participating entities should review their 340B program policies and procedures...more