The End of COVID Waivers and Exceptions: What Now?
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
NGE On Demand: COVID-19 and IP Waiver for Patent Protection with Kevin O'Connor and Olivia Luk Bedi
Prohibitions on Use of Chinese Telecommunications Equipment and Services, Complying with the NDAA
COVID-19: Where are we now?
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Value-based health care: fraud & abuse laws
What patients misunderstand about their right of informed consent
Bill on Bankruptcy: ResCap Report, a Bargain at $83 Million
Federal and local governments have issued numerous waivers and provided significant funding in order to enable health care providers to combat the COVID-19 pandemic. These waivers and additional funding have given providers...more
As healthcare moves increasingly from fee-for-service model to one focused on outcomes and value-based payments, the traditional fraud and abuse laws, such as the Anti-Kickback Statute and the Stark Law, pose obstacles to...more
Amidst the cavalcade of regulatory and policy changes from federal and state governments intended to help health care providers confront the COVID-19 pandemic, on April 21, 2020 the Centers for Medicare & Medicaid Services...more
On April 21, 2020, the Centers for Medicare & Medicaid Services (CMS) issued additional guidance explaining the scope and application of the Stark Law blanket waivers to certain financial relationships. CMS issued the Stark...more
The OIG recently released proposed revisions to the Anti-Kickback Statute (AKS) and Civil Monetary Penalties (CMP) Law. Several of these changes, if finalized, will directly benefit companies offering telemedicine and digital...more
On February 14, 2019, CMS’ Innovation Center announced its Emergency Triage, Treat, and Transport (ET3) Model for EMS / ambulance suppliers to partner with other health care providers such as telehealth entities and urgent...more
On January 14, 2019, the Health and Human Services Office of Inspector General (OIG) published a favorable Advisory Opinion allowing a charitable pediatric clinic (Clinic) to routinely waive cost-sharing amounts for patients...more
The Centers for Medicare & Medicaid Services (“CMS”) recently proposed a major redesign of its Medicare Shared Savings Program (“MSSP”) under a new plan it calls “Pathways to Success.” In this Part II of the two-part series...more
The Office of Inspector General (OIG) recently issued Advisory Opinion 17-02, allowing waivers or reductions of cost-sharing amounts owed by financially needy Medicare beneficiaries in connection with certain clinical...more
Nearly four years after publishing their joint interim final rule with comment period, effective November 2, 2011 (IFC), the OIG and CMS (Agencies) have finalized the waivers of various fraud and abuse laws in the context of...more