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
On March 13, the NCAA issued guidance in the form of a Q&A defining the scope of the eligibility waiver it previously approved on December 23, 2024, for student-athletes who have competed at non-NCAA institutions, such as...more
The Centers for Medicare & Medicaid Services (CMS) recently issued a Fact Sheet (Fact Sheet) providing guidance on the impact of the end of the federal COVID-19 Public Health Emergency (PHE) on certain regulatory waivers,...more
Certain COVID-19 emergency declaration blanket waivers are being phased out by the federal government, and health care providers should take steps to determine whether current arrangements are compliant. As background, in...more
Applicants for Adjustment of Status to Permanent Residence will have more than 60 days after completing their medical examinations to file their Forms I-485 Adjustment of Status applications, USCIS has announced...more
The Department of Health and Human Services (HHS) recently released new practice guidance on buprenorphine administration in an effort to make evidence-based treatment for opioid use disorder more accessible to persons...more
IRS Notice 2020-51, released last week, provides additional guidance on the waiver in 2020 of required minimum distributions (RMDs) from defined contribution retirement plans and IRAs, and the interaction of this waiver with...more
On May 12, the California Department of Consumer Affairs (DCA) issued an Order Waiving Restrictions on Pharmacists Ordering and Collecting Specimens for COVID-19 Tests, under the authority of California Governor Newsom’s...more
On March 30, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued certain blanket waivers of sanctions under the federal physician self-referral law (or “Stark Law”) for “COVID-19 Purposes” (the “Stark Blanket...more
As long term care (LTC) facility cases of COVID-19 continue to rise, the Centers for Medicare and Medicaid Services (CMS) remains vigilant in its efforts to regulate the delivery of adequate care to those residents with...more
This document describes guidance issued during, or in response to, the COVID-19 crisis which impacts the provision of medical treatment via technological means (generally referred to as “telehealth” or “telemedicine”). It is...more
When the President has declared a national emergency under authorizing legislation, the Secretary of the U.S. Department of Health and Human Services is authorized to grant waivers to certain prohibitions under the Social...more
In the face of these unprecedented times brought on by the COVID-19 pandemic, pharmacies are grappling to find ways to protect patients and employees. In response, state officials and boards of pharmacies have reacted in a...more
Over the past week, the Centers for Medicare & Medicaid Services (CMS) has made a number of announcements related to Medicare coverage in connection with the Coronavirus (COVID-19) outbreak. Several of those announcements...more
On Monday, March 9, 2020, the Centers for Medicare and Medicaid (CMS) released information on permissible flexibilities and obligations that are in effect during a disaster and emergency resulting from COVID-19....more