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 April 12, 2024, the Texas Supreme Court handed down two decisions clarifying its interpretation of governmental immunity and waiver under Section 271.152 of the Texas Local Government Code. Governmental units, including...more
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
In a scathing opinion, Southern District of New York Judge Ronnie Abrams recently blasted the SEC’s standard demand that defendants settling with the Commission agree never to deny the allegations against them. Judge Abrams’...more
There is no question in my mind that the quality of FINRA examiners is a bit uneven. Some are smart and insightful and helpful; others are, well, not. Most of the time, they do know what they’re talking about. That means...more
On May 5, 2021, OIG issued guidance on its COVID-19 Administrative Enforcement FAQs page stating that an ambulance provider or supplier waiving or discounting Medicare beneficiary cost-sharing obligations presents a low risk...more
Telehealth has become an integral part of care delivery, particularly in light of the waivers instituted during COVID-19. However, these flexibilities remain in flux and at the same time, government scrutiny and enforcement...more
Republican-appointee Commissioners Roisman and Peirce issued a statement on February 12 publicly disagreeing with Acting Chair Lee’s recent fiat discontinuing the Enforcement Division’s practice of proposing settlements that...more
The new Administration in Washington brings an expectation of change at the SEC in many areas, one of them being SEC Enforcement, where a shift toward more aggressive enforcement is anticipated. That change has already begun....more
On February 11, SEC Acting Chair Lee announced that the Commission no longer would permit settlements in enforcement actions to include, or be contingent on the grant of, waivers of statutory disqualifications that flow from...more
The Equal Employment Opportunity Commission (“EEOC”)—the agency tasked with enforcing federal labor laws—was deputized by Congress in 1972 with authority to bring lawsuits against employers for violating anti-discrimination...more
Calls for Significant Changes To Federal Domestic Preference Policy, Waivers, and Buy American Eligibility - President Biden signed an executive order (order or EO) on January 25, 2021, to direct more spending of the...more
Historically, one of the surest ways to get yourself permanently barred from the industry is to forge a customer’s signature on something. According to the pertinent Sanction Guideline, at a minimum, a forgery, that is, a...more
With 2020 officially behind us, what does 2021 have in store for telemedicine and digital health policy? A year ago, our team predicted 2020 would bring “notable expansions in Medicare and Medicaid coverage” and “the...more
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
HCCA has assembled a half-day virtual conference to help compliance professionals stay on top of the fast-moving changes caused by the COVID-19 pandemic. By participating in this event, you will hear directly from the...more
Last week, the Alaska Department of Environmental Conservation (“ADEC”) issued two No Action Assurance Memorandums, one from the Division of Water (“Water Memo”) and one from the Division of Air Quality (“Air Memo”), to...more
The Environmental Protection Agency (EPA) has issued a memorandum describing how and when the Agency will implement temporary enforcement discretion for certain federal environmental noncompliance during the COVID-19...more
Certain “bad actors” who settle with the SEC may be subject to automatic disqualifications or collateral consequences under federal securities laws and regulations. The Commission, however, may grant a settling party’s...more
Over the past several weeks, competing views have emerged from Capitol Hill and the SEC over how the Securities and Exchange Commission (“SEC” or “Commission”) should approach waivers of collateral consequences for parties...more
In a public statement, SEC Chairman Jay Clayton discussed the historical interplay between settlement offers and related waiver requests. Chair Clayton noted...more
A recent bill has been introduced again in the US House of Representatives that would make it much tougher for firms subject to SEC enforcement actions to obtain waivers for bad actor disqualifications in federal securities...more
Protection of industrial control systems is crucial to the security of our country. The National Cybersecurity Center of Excellence (NCCoE) has announced a project for which it is seeking comment: Detecting and Protecting...more
Way back in 2006, NASD issued Notice to Members 06-55, which tweaked the Sanction Guidelines to allow not just the size of the firm to be taken into consideration when determining the appropriate sanctions to be meted out,...more
ANTICORRUPTION DEVELOPMENTS - DOJ Extends FCPA Corporate Enforcement Policy to Misconduct in Mergers and Acquisitions - On July 25, 2018, in a speech to the Ninth Global Forum on Anti-Corruption Compliance in High Risk...more
Bass, Berry & Sims attorney Chris Lazarini commented on a case in which a former commodities broker appealed a decision ordering him to pay restitution to his former firm which had made its customers whole after the broker's...more