Policy & Compliance

Expert Analysis

• The Regulatory Headwinds Facing Lab-Developed Tests

  

  Though the U.S. Food and Drug Administration's final rule regarding regulation of laboratory-developed tests outlines a four-year plan for ending enforcement discretion, and though this rule is currently being challenged in courts, manufacturers should heed compliance opportunities immediately as enforcement actions are already on the horizon, say attorneys at Kirkland & Ellis.

• 3 High Court Rulings May Shape Health Org. Litigation Tactics

  

  Three separate decisions from the U.S. Supreme Court's most recent term — Loper Bright, Corner Post and Jarkesy — will likely strengthen healthcare organizations' ability to affirmatively sue executive agencies to challenge regulations governing operations and enforcement actions, say attorneys at McDermott.

• A New Way Forward For COVID Vaccine Lawsuit Immunity

  

  As Public Readiness and Emergency Preparedness Act protections for COVID-19 vaccines wane, adding those vaccines to coverage by the National Vaccine Injury Compensation Program would bolster defenses for administrators and manufacturers while also providing stronger remedies for those injured by vaccines, says Altom Maglio at MCT Law.

• Why DOJ's Whistleblower Program May Have Limited Impact

  

  The U.S. Department of Justice’s new whistleblower pilot program aims to incentivize individuals to report corporate misconduct, but the program's effectiveness may be undercut by its differences from other federal agencies’ whistleblower programs and its interplay with other DOJ policies, say attorneys at Milbank.

• How Cos. With Chinese Suppliers Should Prep For Biotech Bill

  

  A proposed bill to prohibit government-affiliated life sciences companies from contracting with Chinese biotech companies of concern may necessitate switching to other sources for research and supplies, meaning they should begin evaluating supply chains now due to the long lead times of drug development, say John O'Loughlin and Christina Carone at Weil Gotshal.

• FTC's Drug Middlemen Probe Highlights Ongoing Scrutiny

  

  The Federal Trade Commission's interim staff report on its inquiry into pharmacy benefit managers suggests that the industry will remain under an enforcement microscope for the foreseeable future due to concerns about how PBMs affect drug costs and accessibility, say attorneys at Arnold & Porter.

• What Cos. Should Note In DOJ's New Whistleblower Pilot

  

  After the U.S. Department of Justice unveiled a new whistleblower pilot program last week — continuing its efforts to incentivize individual reporting of misconduct — companies should review the eligibility criteria, update their compliance programs and consider the risks and benefits of making their own self-disclosures, say attorneys at Skadden.

• Motion To Transfer Venue Considerations For FCA Cases

  

  Several recent decisions highlight the importance for practitioners of analyzing as early as possible whether a False Claims Act case warrants a change of venue, and understanding how courts weigh certain factors for defendants versus whistleblowers, say Ellen London at London & Stout, and Li Yu and Corey Lipton at DiCello Levitt.

• A Primer On EU's Updated Human Substance Regulations

  

  The European Union's updated standards regarding quality and safety of substances of human origin meant for human application carry significant implications for companies that work with cells and tissues, and U.S. companies active in the EU market should pay particular attention to the import and export rules, say Geneviève Michaux and Georgios Symeonidis at King & Spalding.

• CFPB's Medical Debt Proposal May Have Side Effects

  

  The Consumer Financial Protection Bureau’s recent proposal to prevent medical debt information from appearing on consumer reports and creditors from basing lending decisions on such information may have initial benefits for some consumers, but there are potential negative consequences that should also be considered, say attorneys at Cooley.

• 15 Areas That Would Change Under Health Data Rule Proposal

  

  If finalized, the Office of the National Coordinator for Health Information Technology's proposed rule will significantly progress its efforts to advance interoperability, respond to stakeholder concerns and clarify compliance with the health IT certification program, say attorneys at Ropes & Gray.

• 3 Healthcare FCA Deals Provide Self-Disclosure Takeaways

  

  Several civil False Claims Act settlements of alleged healthcare fraud violations over the past year demonstrate that healthcare providers may benefit substantially from voluntarily disclosing potential misconduct to both the U.S. Department of Justice and the U.S. Department of Health and Human Services, say Brian Albritton and Raquel Ramirez Jefferson at Phelps Dunbar.

• Takeaways From High Court's Tribal Health Admin Cost Ruling

  

  The U.S. Supreme Court's recent determination that the government must reimburse two Native American tribes for administrative healthcare costs will help tribes maintain equal footing with the Indian Health Service when administering programs, and continues a pattern of how the current court aligns on tribal concerns, say attorneys at Lewis Roca.