ML Strategies: 340B Discount Drug Program Guidance Submitted to OMB

By Samantha P. Kingsbury

Earlier this week, ML Strategies (MLS) posted its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.

In its most recent edition, MLS highlights the submission of 340B discount drug program guidance to the Office of Management and Budget for review.  This guidance has been highly anticipated since a number of legal challenges in 2014 called into question the authority of the Health Resources and Services Administration to oversee certain aspects this program.

Among a number of other topics, MLS also discusses the HHS Office of the National Coordinator for Health Information Technology’s release of a revised version 2.0 of their Guide to Privacy and Security of Electronic Health Information, as well as CMS's finding that the Pioneer ACO program saved $348 million over two years.

Past Health Care Updates are available here.

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Samantha P. Kingsbury

Of Counsel

Samantha advises clients on regulatory and enforcement matters. She has deep experience handling violations of the federal ant-kickback statute and FCA investigations for clinical laboratories and hospitals.