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
The West Virginia Intermediate Court of Appeals reversed a decision that a national broker franchisor, Ameriprise Financial, Inc., fraudulently induced a franchisee into buying the business of another Ameriprise franchisee,...more
In United States v. Lewis, the Second Circuit (per curiam) affirmed the judgment of conviction of Chanette Lewis, who had pleaded guilty to two counts of conspiracy to commit wire fraud in violation of 18 U.S.C. § 371. The...more
Republicans have swept the 2024 elections, returning Donald Trump to the White House as the 47th President and flipping the Senate to a Republican majority. Having narrowly maintained control of the House of Representatives,...more
In In re Cadira Group Holdings, LLC (2021 WL 2912479 (Del. Ch. July 12, 2021)), the Delaware Court of Chancery has again shown its inclination to treat an agreement that purports to replace traditional fiduciary duties with...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 Swipe Acquisition Corp. v. Krauss, CA No. 2019-0509-PAF, 2021 WL 282642 (Del. Ch. Jan. 28, 2021), the Delaware Court of Chancery held that California public policy prohibited a purported waiver of a contractual party’s...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
A federal appeals court reversed dismissal of a claim against a barbeque restaurant franchisor. The court found that, despite having signed releases in favor of the franchisor, a former franchisee had valid claims for...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
Although a whistleblowing employee typically cannot release fraud claims against her employer brought on behalf of the United States under the False Claims Act (FCA), courts have demonstrated a willingness to enforce properly...more
In a recent decision, the Texas Supreme Court upheld a contractual waiver of punitive damages despite a finding of fraud by the seller in the sale of a supposedly new aircraft that instead contained used and repaired engines....more
Guarantors of loans occupy a vulnerable position under California law. While direct borrowers often benefit from California’s robust statutory anti-deficiency framework, those protections are often unavailable for...more
California Employees Can Waive Class Claims In An Arbitration Agreement, But Not PAGA Claims - Resolving an issue that has created uncertainty for California employers, the California Supreme Court recently held in...more