Policy & Compliance

Expert Analysis

• DOJ's Biopharma Settlement Raises Anti-Kickback Questions

  

  In the aftermath of the U.S. Department of Justice's settlement with Ultragenyx over genetic testing programs, it may be prudent to reevaluate genetic tests through the lens of the Anti-Kickback Statute and reconsider whether it is proper for free testing programs to be treated like patient assistance programs, says Mary Kohler at Kohler Health Law.

• Where Justices Stand On Chevron Doctrine Post-Argument

  

  Following recent oral argument at the U.S. Supreme Court, at least four justices appear to be in favor of overturning the long-standing Chevron deference, and three justices seem ready to uphold it, which means the ultimate decision may rest on Chief Justice John Roberts' vote, say Wayne D'Angelo and Zachary Lee at Kelley Drye.

• Bracing For Calif.'s New Health Transaction Framework

  

  As California's new cost and market impact review regulations' April 1 date for its updated notice and review process approaches, healthcare entities should ready themselves for dramatic changes to the state's regulatory landscape and prepare for potentially substantial transaction delays, say Jordan Grushkin and Matthew Goldman at Sheppard Mullin.

• Uncharted Waters Ahead For FCA Litigation In 2024

  

  Following a year of significant court decisions, settlements, recoveries and proposed amendments, 2024 promises to be a lively year for False Claims Act actions and litigation, and one that will hopefully provide more clarity as FCA jurisprudence evolves, say attorneys at Crowell & Moring.

• OIG Report Has Clues For 2024 Healthcare Fraud Enforcement

  

  A recent report from the Health Department's Office of the Inspector General reveals healthcare fraud and abuse enforcement trends that will continue in 2024, from increased telehealth oversight to enhanced policing of managed care, say attorneys at Sheppard Mullin.

• FOIA Exemption Questions On Redacted HHS Cannabis Letter

  

  The U.S. Department of Health and Human Services' recent recommendation letter concerning the rescheduling of cannabis was heavily redacted, and based on an analysis on the applicability of Freedom of Information Act Exemption 5 to the letter, it's likely that we will see successful legal challenges to those redactions, say attorneys at Troutman Pepper.

• A Primer On New Calif. Health Transaction Reporting Rules

  

  New California regulations regarding the reporting of certain transactions involving healthcare entities, which took effect on Jan. 1, address some industry feedback about overly broad requirements but still leave several areas of concern, says Andrew Demetriou at Husch Blackwell.

• In The CFPB Playbook: Rulemaking Rush Before Election Year

  

  In this quarterly Consumer Financial Protection Bureau activity recap by former bureau personnel, attorneys at McGuireWoods explain the regulator's recent push to finalize new rules about data aggregators, digital payment apps and more before the election-year Congressional Review Act window opens.

• What The Law Firm Of The Future Will Look Like

  

  As the legal landscape shifts, it’s become increasingly clear that the BigLaw business model must adapt in four key ways to remain viable, from fostering workplace flexibility to embracing technology, say Kevin Henderson and Eric Pacifici at SMB Law Group.

• 4 PR Pointers When Your Case Is In The News

  

  Media coverage of new lawsuits exploded last year, demonstrating why defense attorneys should devise a public relations plan that complements their legal strategy, incorporating several objectives to balance ethical obligations and advocacy, say Nathan Burchfiel at Pinkston and Ryan June at Castañeda + Heidelman.

• Digging Into The Debate On FDA's Proposed Lab Test Rule

  

  A proposed 10-word amendment from the U.S. Food and Drug Administration represents a sea change in device regulation as it would summarily end decades of FDA enforcement discretion for laboratory developed tests, and the public comments offer some insight into the future of this long-running saga, say attorneys at Mintz.

• Law Firm Strategies For Successfully Navigating 2024 Trends

  

  Though law firms face the dual challenge of external and internal pressures as they enter 2024, firms willing to pivot will be able to stand out by adapting to stakeholder needs and reimagining their infrastructure, says Shireen Hilal at Maior Consultants.

• AI In Health Law: The Top Guest Articles Of 2023

  

  As the use of artificial intelligence accelerated this year, Expert Analysis writers examined AI's significant impact on the healthcare sector, ranging from key compliance considerations for companies utilizing AI tools to regulators' efforts to keep up with rapidly evolving technologies.