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Narrowly Defined Drug Patient Assistance Programs Spark OIG Advisory

 
• By Scott Steinke

The HHS Office of Inspector General will give greater scrutiny to patient assistance programs that help enrollees in Medicare Part D plans purchase drugs if they only help patients with narrowly defined diseases or limit the range of drugs they will help cover, OIG says in updated guidance.

The HHS Office of Inspector General has concerns about the trends it is seeing among patient assistance programs that help enrollees in Medicare Part D plans purchase drugs and is planning to give greater scrutiny for potential violations of the federal anti-kickback statute to those types of PAPs, according to updated guidance issued May 21.

OIG has allowed independent charities to operate patient assistance programs for enrollees in Part D plans and to take financial donations from pharmaceutical manufacturers. A November 2005 special...

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• By Sue Sutter

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US Most Favored Nations Policy: Higher Drug Spending In Germany Is ‘Difficult To Imagine’

 
• By Francesca Bruce

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More from North America

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• By Laura Helbling

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• By Derrick Gingery

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Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.