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
In June 2024, the U.S. Food and Drug Administration ("FDA") clarified, with respect to the Drug Supply Chain Security Act (“DSCSA”), that it will not extend the one-year stabilization period for the enhanced drug distribution...more
On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more
On August 14, 2023, the Office of Management and Budget (OMB) released a pre-publication version of final guidance implementing the Build America, Buy America Act (BABAA).The guidance adds a new Part 184 in 2 C.F.R. and...more
Delaware Court of Chancery holds contractual waivers of fiduciary duties are facially valid when they are both narrowly tailored to authorize specific transactions and satisfy the Court’s review for reasonableness. Court...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
On September 27, the Food and Drug Administration (FDA) issued two Notices of Proposed Rule Making that would harmonize the FDA’s human subject protection regulations with the Federal Policy for the Protection of Human...more
Editor’s Note: In a new expert perspective prepared for the Robert Wood Johnson Foundation’s State Health and Value Strategies program, reproduced below, Manatt Health outlines the time-limited targeted enrollment...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
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
The Infrastructure Investment and Jobs Act (IIJA), which included the Build America, Buy America Act (the Act), was signed into law on Nov. 15, 2021, and created a deadline of May 14, 2022, for federal agencies to ensure...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
New York’s telehealth emergency waivers have expired, according to a June 25, 2021 announcement issued by Governor Andrew Cuomo’s Office declaring the waivers (contained in Executive Orders 202 through 202.11 and 205 through...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
In one of her first official actions as Acting Chair of the Securities and Exchange Commission (SEC or Commission), Allison Herren Lee reversed a major policy implemented by recently departed SEC Chairman Jay Clayton...more
On July 15, 2020, the Federal Reserve published a number of changes to the Main Street Lending Program’s frequently asked questions, which FAQs were amended to provide further guidance on a number of issues. The Federal...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
Caring for Recipients, Protecting the Workforce and Supporting Provider Sustainability - Examine the Immediate Issues and Opportunities Facing Long-Term Care Providers—and Look Ahead at How to Build a Stronger Future—at a...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