COVID-19 Hahn Announces Some FDA Changes to Be Made Permanent Thomas Sullivan Jul 13, 2020 0 The United States Food and Drug Administration (FDA) made several changes in response to the COVID-19 pandemic, and now FDA…
CMS CMS Releases Proposed Rule to Encourage Value-Based Arrangements Thomas Sullivan Jul 10, 2020 0 In mid-June 2020, the United States Centers for Medicare and Medicaid Services (CMS) released a proposed rule (NPRM),…
Anti Kickback Novartis Settlements and Corporate Integrity Agreement 2020 Version 3.0 Thomas Sullivan Jul 9, 2020 0 Last week, the United States Department of Justice (DOJ) announced a $642 million settlement with Novartis over improper payments…
Government Agencies HHS Final Rule a Win for Copay Accumulator Adjustment Programs Thomas Sullivan Jul 8, 2020 0 On May 14, 2020 the Department of Health and Human Services (HHS) finalized the Notice of Benefit and Payment Parameters for 2021…
DTC DC Circuit Court Holds HHS DTC Disclosure Rule Not Permissible Thomas Sullivan Jul 7, 2020 0 On June 16, 2020, a unanimous panel of the District of Columbia Circuit Court ruled that a rule finalized by the United States…
CMS CMS Reveals Enhanced Nursing Home Enforcement Actions Thomas Sullivan Jul 6, 2020 0 On June 1, 2020, the Centers for Medicare and Medicaid Services (CMS) unveiled enhanced enforcement for nursing homes when it…
Clinical Research FDA Responds to Clinical Trials & Part 11 Compliance During COVID-19 Thomas Sullivan Jul 2, 2020 0 The U.S. Food and Drug Administration (FDA) issued updated guidance on how to conduct clinical trials during the COVID-19 public…
Accountable Care Organizations Medical Shared Savings “Should I Stay or Should I Go”, Provider Groups Ask… Thomas Sullivan Jul 1, 2020 0 Provider groups say accountable care organizations (ACOs) need until October 31 to decide whether to leave the Medicare Shared…
CMS Medicare Hospital Inpatient Proposed Payment Rule Calls for Additional… Thomas Sullivan Jun 30, 2020 0 The Centers for Medicare & Medicaid Services (CMS) released its annual proposal for the Hospital Inpatient Prospective Payment…
CMS CMS Expanded Rules for Medicare Advantage Telehealth Thomas Sullivan Jun 29, 2020 0 The Centers for Medicare & Medicaid Services (CMS) recently announced that for Medicare Advantage (MA) beneficiaries in…