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 August 23, 2023, the U.S. Securities and Exchange Commission (“SEC”), by a party-line vote of 3-2, adopted new rules applicable to investment advisers to private funds (“Private Fund Advisers”) that address transparency,...more
On August 23, 2023, by a vote of 3-2, the Securities and Exchange Commission (the “SEC”) adopted new final rules and amendments to existing rules under the Investment Advisers Act of 1940, as amended (the “Advisers Act”) with...more
Many healthcare providers received waivers and exceptions due to the COVID-19 pandemic, but now with the emergency declaration set to expire sometime in the new year, providers need to ask themselves: What did I change in my...more
Passing the historic $1 trillion Infrastructure Investment and Jobs Act (IIJA) in November 2021, which allocates more than $550 billion in new infrastructure spending, was an early priority of the Biden administration. The...more
Companies who feel the Public Health Emergency (PHE) waivers and exceptions have rendered telemedicine “immune” from compliance oversight might be surprised to learn what federal regulators have in the works. The Office of...more
In response to the ongoing COVID-19 public health emergency (the “PHE”) first declared on March 13, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued blanket Section 1135 Waivers to expand, albeit on a...more
This 27th edition of Unprecedented, our weekly update on COVID-19-related litigation, sees us start with a discussion of a trend toward class actions, with later discussions on two key areas -- insurance coverage disputes and...more
The OIG has indicated concern that patients suffering from opioid use disorder may experience difficulty accessing medication-assisted treatment (MAT), resulting in under-utilization of this intervention that offers what the...more
In the event of a national disaster or emergency under the Stafford Act or the National Emergencies Act and a Public Health Emergency Declaration by government officials, the Department of Health and Human Services (HHS)...more
Examine the Evolving Challenges That Lie Ahead for Healthcare Stakeholders and State Regulators—and What You Can Do Now to Prepare and Protect Your Organization—at a New Manatt Webinar. Effective health insurance...more
Last week, a new audit report was released regarding the Federal Aviation Administration’s (FAA) unmanned aircraft system (UAS or drone) waiver process. According to that audit, the Office of the Inspector General (OIG) has...more
The Office of the Inspector General (OIG) of the U.S. Department of Transportation (DOT) has announced an audit of the Federal Aviation Administration’s (FAA) “approval and oversight processes” for Part 107 waivers for...more
With many state legislatures wrapping up session within the past month or so, there has been a flurry of last-minute tax amnesty legislation passed. Nearly a half-dozen states have authorized upcoming tax amnesty periods....more
Obtaining a valid waiver of minimum wage or overtime claims under the Fair Labor Standards Act (FLSA) continues to be tricky. Section 216(c) of the FLSA requires that a valid waiver must be “supervised” by the U.S. Department...more
As you end your telephone conversation with the revenue examiner, you think to yourself, “Thank goodness, this one is finally over!” The audit of your biggest client started over three years ago, and has seemingly dragged on...more
The New York State Department of Environmental Conservation ("DEC") has issued a new Environmental Audit Incentive Policy (Commissioner Policy No. 59) that is intended to encourage regulated entities to audit their practices...more
In This Issue: Consultations; New Listing Decisions; Regulatory Watch; New Guidance Letters; and Enforcement News. Excerpt from Consultations - Exchange’s Consultations on Review of Connected Transaction...more