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Nov 21, 2024 | 
mondaq.com | Laurence J. Freedman |Xavier G. Hardy |Abdie Santiago
On November 12, 2024, the drug manufacturer Johnson &
Johnson (J&J) filed a lawsuit against the Health Resources and
Services Administration (HRSA) in the United States District Court
for the District of Columbia. The lawsuit relates to
J&J's proposal to require certain 340B covered entities
– specifically, disproportionate share hospitals (DSH)
– that purchase J&J's drugs Stelara and Xarelto
under the 340B Drug Pricing Program (340B Program) to do so under a
rebate model.
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Nov 3, 2024 | 
mondaq.com | Xavier G. Hardy |Abdie Santiago
On September 26, 2024, the Centers for Medicare & Medicaid
Services (CMS) released a final rule implementing changes to the
Medicaid Drug Rebate Program (MDRP). While not the focus of the
agency's rulemaking, stakeholders used the opportunity to
comment on the proposed rule to air concerns and grievances
related to the 340B Drug Pricing Program (340B Program).
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Oct 30, 2024 | 
jdsupra.com | Xavier G. Hardy |Abdie Santiago
On September 26, 2024, the Centers for Medicare & Medicaid Services (CMS) released a final rule implementing changes to the Medicaid Drug Rebate Program (MDRP). While not the focus of the agency’s rulemaking, stakeholders used the opportunity to comment on the proposed rule to air concerns and grievances related to the 340B Drug Pricing Program (340B Program).
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Oct 30, 2024 | 
natlawreview.com | Xavier G. Hardy |Abdie Santiago |Gregory Husisian |Allison S. Zangrilli
Skip to main content October 30, 2024 Volume XIV, Number 304 Legal Analysis. Expertly Written. Quickly Found.
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Aug 20, 2024 | 
lexology.com | Rachel Alexander |Theresa C. Carnegie |Xavier G. Hardy |Alison Peters |Madison Castle
On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug Price Negotiation Program (MPN or Program).
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Jul 31, 2024 | 
lexology.com | Theresa C. Carnegie |Rachel Alexander |Madison Castle |Xavier G. Hardy |Stephnie A. John |Alison Peters | +8 more
The PBM regulatory landscape is rapidly evolving at both federal and state levels, making it critical for our clients involved in the PBM space to stay apprised of developments in the industry as they happen. Our team actively monitors these developments to provide you with this PBM Policy and Legislative Update. This update builds on prior issues and highlights federal and state activity from January 2024 through June 2024.
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Jul 31, 2024 | lexology.com | Theresa C. Carnegie |Rachel Alexander |Madison Castle |Xavier G. Hardy |Stephnie A. John |Alison Peters | +8 more
The PBM regulatory landscape is rapidly evolving at both federal and state levels, making it critical for our clients involved in the PBM space to stay apprised of developments in the industry as they happen. Our team actively monitors these developments to provide you with this PBM Policy and Legislative Update. This update builds on prior issues and highlights federal and state activity from January 2024 through June 2024.
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Jul 18, 2024 | 
medium.com | Xavier G. Hardy
My first experiences with social media involve the video uploading platform of YouTube. At the age of 8, I clearly remember when I would stay up late watching YouTube videos on my tablet of well acclaimed channels such as theRadBrad and Typical Gamer. I also remember sneaking downstairs and watching on my mom's phone, hoping that she would not wake. It was a very addicting activity and that's the very sentiment of social media.
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Jul 16, 2024 | 
natlawreview.com | Richard Newman |Carl Hinze |Mitchell Riggs |Xavier G. Hardy
The healthcare industry is once again under scrutiny as Rite Aid Corporation and its subsidiaries, Elixir Insurance Company, RX Options LLC, and RX Solutions LLC, have agreed to a substantial settlement of $101 million. This settlement addresses allegations that the retail pharmacy chain, its related Medicare drug plan sponsor, and its affiliated pharmacy benefit managers (PBM) falsely reported drug rebates under the Medicare Part D program.
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Jul 15, 2024 | 
natlawreview.com | Xavier G. Hardy
The IRA’s Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”), which enables the federal government to negotiate prices for some of the costliest Medicare Part D drugs, has been subject to several legal challenges over the last year. Manufacturers and trade associations began filing lawsuits against the government even before the first 10 negotiation-eligible drugs were published in late August 2023.
