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…
Monthly Publications
In Depth
Subscribe Now
In Depth
coverage of timely
Life Science
Compliance issues
Subscribe Now
Yearly Archives
2020
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…
FDA Responds to Clinical Trials & Part 11 Compliance During COVID-19
The U.S. Food and Drug Administration (FDA) issued updated guidance on how to conduct clinical trials during the COVID-19 public…
Medical Shared Savings “Should I Stay or Should I Go”, Provider Groups Ask…
Provider groups say accountable care organizations (ACOs) need until October 31 to decide whether to leave the Medicare Shared…
Medicare Hospital Inpatient Proposed Payment Rule Calls for Additional…
The Centers for Medicare & Medicaid Services (CMS) released its annual proposal for the Hospital Inpatient Prospective Payment…
CMS Expanded Rules for Medicare Advantage Telehealth
The Centers for Medicare & Medicaid Services (CMS) recently announced that for Medicare Advantage (MA) beneficiaries in…