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CMS Finalizes Permanent Changes for Certain Telehealth Services Modified During COVID-19 Public Health Emergency

USA - January 5 2021 On December 1, 2020, the Centers for Medicare & Medicaid Services ("CMS") released the annual Physician Fee Schedule Final Rule ("Final Rule"). Among…

Deborah Kantar Gardner, Moussa Hassoun.

Cutting Out the “Middleman”? HHS Resurrects Anti-Rebate Rule for Medicare Part D

USA - December 9 2020 On November 20, 2020 the Department of Health and Human Services ("HHS") and the HHS Office of Inspector General ("OIG") issued a final rule ("Final…

Margaux J. Hall, Ryan B. Marcus, Thomas N. Bulleit.

Senate Republicans Introduce the Health, Economic Assistance, Liability Protection and Schools Act (HEALS Act)

USA - August 17 2020 At the end of July, Senate Republican leaders announced the Health, Economic Assistance, Liability Protection and Schools Act (HEALS). The HEALS Act…

Kelly Hamachi, Moussa Hassoun, Thomas N. Bulleit.

COVID-19 Disruptions of International Clinical Trials: Comparing Guidances Issued by Key European National Regulatory Authorities, the Australian Department of Health, Brazil’s ANVISA, Health Canada and Singapore’s HSA

Australia, Brazil, Canada, European Union, France, Germany, Italy, Singapore, Spain, Switzerland - April 8 2020 The COVID-19 pandemic has had a major impact on the conduct of clinical trials worldwide. Recognizing this impact, National authorities have issued…

David Peloquin, Elizabeth King, Mark Barnes.

COVID-19 Disruptions of International Clinical Trials: Comparing Guidances Issued by FDA, EMA, MHRA and PMDA

European Union, Japan, United Kingdom, USA - April 2 2020 The COVID-19 pandemic has had a major impact on the conduct of clinical trials worldwide. Recognizing this impact, national authorities have issued…

David Peloquin, Elizabeth King, Mark Barnes.