Health Care Law News and Insights

340B Drug Program Price Ceiling And Penalties Moved Up To Start January 1st

Published: Dec 20, 2018
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On November 30, 2018, the Department of Health and Human Services (HHS) issued a final rule that puts in effect January 1, 2019, rather than July 1, 2019 as previously announced significant changes to the 340B program including a ceiling price on how much drug manufactures can charge hospitals who participate in...

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Overview Of The Virginia 1115 Medicaid Waiver Application

Published: Dec 10, 2018
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On November 20, 2018, Virginia submitted an application to CMS for a Section 1115 demonstration program entitled Virginia COMPASS (Creating Opportunities for Medicaid Participants to Achieve Self-Sufficiency). The application comes after Virginia voted in June 2018 to expand its Medicaid program to cover newly eligible non-disabled, non-pregnant adults ages 19 to 64...

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Update On Clinical Trials Transparency In The EU

Published: Nov 26, 2018
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Publication of clinical trial data and results continues to be a hot topic in the EU. A recent BMJ article investigated the level of compliance with the European Commission's requirement that the results of all trials are published within 12 months of completion. The Commission guidance expands on the obligations in the Clinical Trials Directive,...

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