HHS Not Using New Authority to Hire Top Scientists at FDA and NIH
A recent study by the Government Accountability Office (GAO) found that the Department of Health and Human Services (HHS) is not…
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July 2020
FCC Chair Ajit Pai Issues Call to Expand Telehealth
FCC Chairman Ajit Pai called upon Congress for additional flexibility to expand telehealth at a recent event. During the Axios…
Prior Authorization Changes Driven by the COVID-19 Pandemic
By Robert Popovian & Amanda DeMarzo
Many hospitals have shifted staff resources from administrative functions to direct…
Alexion Reaches Agreement in Principle with SEC Over FCPA Violations
In its May 2020 annual report filed with the United States Securities and Exchange Commission (SEC), Alexion Pharmaceuticals,…
Hahn Announces Some FDA Changes to Be Made Permanent
The United States Food and Drug Administration (FDA) made several changes in response to the COVID-19 pandemic, and now FDA…
CMS Releases Proposed Rule to Encourage Value-Based Arrangements
In mid-June 2020, the United States Centers for Medicare and Medicaid Services (CMS) released a proposed rule (NPRM),…
Novartis Settlements and Corporate Integrity Agreement 2020 Version 3.0
Last week, the United States Department of Justice (DOJ) announced a $642 million settlement with Novartis over improper payments…
HHS Final Rule a Win for Copay Accumulator Adjustment Programs
On May 14, 2020 the Department of Health and Human Services (HHS) finalized the Notice of Benefit and Payment Parameters for 2021…
DC Circuit Court Holds HHS DTC Disclosure Rule Not Permissible
On June 16, 2020, a unanimous panel of the District of Columbia Circuit Court ruled that a rule finalized by the United States…
CMS Reveals Enhanced Nursing Home Enforcement Actions
On June 1, 2020, the Centers for Medicare and Medicaid Services (CMS) unveiled enhanced enforcement for nursing homes when it…