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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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Sep 18, 2024 | 
mondaq.com | Pat G. Ouellette |Abdie Santiago
M
Mintz
More
Mintz is a general practice, full-service Am Law 100 law firm with more than 600 attorneys. We are headquartered in Boston and have additional US offices in Los Angeles, Miami, New York City, San Diego, San Francisco, and Washington, DC, as well as an office in Toronto, Canada.
As we enter into the final months of 2024, new developments in the administration of the 340B Drug Pricing Program signal that additional reform may be on the way.
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Sep 17, 2024 | 
natlawreview.com | Abdie Santiago |Pat G. Ouellette |James G. Gatto |A.J. Dhaliwal
Skip to main content September 17, 2024 Volume XIV, Number 261 Legal Analysis. Expertly Written. Quickly Found.
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Sep 17, 2024 | 
lexology.com | Abdie Santiago |Pat G. Ouellette
As we enter into the final months of 2024, new developments in the administration of the 340B Drug Pricing Program signal that additional reform may be on the way. Although recent revisions to the 340B program’s administrative dispute resolution (ADR) process represented a positive development in program reform, many questions remain as to how the Health Resources and Services Administration (HRSA) along with Congress may resolve stakeholder concerns with the drug pricing program’s future.
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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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May 17, 2024 | 
jdsupra.com | Pat G. Ouellette |Abdie Santiago
On April 18, 2024, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) released a new Final Rule for its oft-criticized 340B Administrative Dispute Resolution (ADR) Program (2024 Final Rule). The 340B ADR process was mandated by the Affordable Care Act and enacted in 2012.
