Crafting a new pharmacy benefit manager (PBM) agreement may feel like an uphill battle when you do not have the time and resources to develop a highly customized contract. While it is often more beneficial to a health plan to...more
On April 25, 2023, the Senate Health, Education, Labor, and Pensions Committee Chairman Bernie Sanders and Ranking Member Bill Cassidy introduced a package of legislation aimed at lowering prescription drug prices. The...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 recently released data collected through the Open Payments Program in accordance with the Affordable Care Act from applicable manufacturers and group purchasing organizations (GPOs) about payments and other transfers that...more
As we told you about here, the Centers for Medicare & Medicaid Services (CMS) has been dealing with issues related to its Open Payments database of payments and transfers of value reported by manufacturers and group...more
With the June 30 deadline for Phase 2 Sunshine Act reports by pharmaceutical and medical device manufacturers (“Applicable Manufacturers”) and group purchasing organizations (“GPOs’) quickly approaching, the Centers for...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
Under the Physician Payments Sunshine Act, pharmaceutical and medical device manufacturers and group purchasing organizations (GPOs) are required to annually report payments or other transfers of value made to physicians and...more
The Centers for Medicare & Medicaid Services (“CMS”) recently released guidance on its website describing a two-phase process for applicable manufacturers and group purchasing organizations (“GPOs”) to register and submit...more
On Friday, February 7, 2014, the Centers for Medicare and Medicaid Services (CMS) announced that Open Payments registration is scheduled to begin on Tuesday, February 18, 2014 for applicable manufacturers and applicable group...more
On Friday, February 7, 2014, CMS announced that Open Payments registration is scheduled to begin on Tuesday, February 18, 2014 for applicable manufacturers and applicable group purchasing organizations (GPOs). ...more
Last week, the Centers for Medicare & Medicaid Services (“CMS”) clouded the process for pharmaceutical and medical device manufacturers, and group purchasing organizations (“GPOs”), to register and submit reports under the...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