In a move long anticipated by 340B Program participants, the Department of Health and Human Services (HHS) recently published its finalized 340B Administrative Dispute Resolution (ADR) rule, establishing formal processes for...more
4/25/2024
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Drug Pricing ,
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Healthcare ,
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Regulatory Requirements ,
Section 340B
Although we are only two and a half months in, 2024 has already seen its fair share of impactful 340B developments on both the litigation and legislative fronts....more
3/14/2024
/ Drug Distribution ,
Drug Pricing ,
Food & Drug Regulations ,
Healthcare ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Legislation ,
Regulatory Agenda ,
Request For Information ,
Section 340B
Although 340B-participating covered entities likely don’t need the reminder, numerous manufacturers continue to significantly restrict 340B pricing available via traditional “bill to/ship to” contract pharmacy models, with...more
9/20/2023
/ Drug Distribution ,
DSCSA ,
Food & Drug Regulations ,
Healthcare ,
Life Sciences ,
Manufacturers ,
Payor Contracts ,
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Prescription Drugs ,
Section 340B ,
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Supply Chain