Policy & Compliance

Expert Analysis

• The Road Ahead For Florida's Drug Importation Program

  

  Though the U.S. Food and Drug Administration approved Florida's drug importation program in January, a series of hurdles — including requisite buy-in from Canada — and potential legal challenges must be addressed before importation can begin, say attorneys at Ropes & Gray.

• Assessing CDC's Revised Guideline On Opioid Prescriptions

  

  Kenneth Weinstein, Nicholas Van Niel and Kate Uthe at Analysis Group look at newly available data to evaluate the impact that the Centers for Disease Control and Prevention's revised opioid monitoring guideline have had on prescription trends in recent years, highlighting both specific and overall decreases.

• Valeant Ruling May Pave Way For Patent-Based FCA Suits

  

  The Ninth Circuit’s recent ruling in Silbersher v. Valeant marks a significant development in False Claims Act jurisprudence, opens new avenues for litigation and potentially raises the stakes for patent applicants who intend to do business with the government, say Joshua Robbins and Rick Taché at Buchalter.

• Suits Against Insulin Pricing Are Driven By Rebate Addiction

  

  A growing wave of lawsuits filed by states, cities and counties against insulin manufacturers and pharmacy benefit managers improperly allocate the blame for rising insulin costs, when in actuality the plaintiffs are partially responsible, says Dan Leonard at Granite Capitol Consulting.

• When Physician Retirement Arrangements May Be Legal

  

  A recent advisory opinion from the Office of Inspector General regarding physician retirement arrangements sheds light on key considerations and mitigating factors that may be useful when attempting to balance healthcare operational needs with statutory conformity, says Magda Rodriguez at Day Pitney.

• ESG Around The World: Gulf Cooperation Council

  

  The Gulf Cooperation Council is in the early stages of ESG policy implementation, but recent commitments by both states and corporations — including increases in sustainable finance transactions, environmental commitments, female representation on boards and human rights enforcement — show continuing progress toward broader ESG goals, say attorneys at Cleary.

• Navigating ACA Reporting Nuances As Deadlines Loom

  

  Stephanie Lowe at Liebert Cassidy walks employers through need-to-know elements of Affordable Care Act reporting, including two quickly approaching deadlines, the updated affordability threshold, strategies for choosing an affordability safe harbor, and common coding pitfalls.

• Lessons From Rare Post-Verdict Healthcare Fraud Acquittal

  

  A Maryland federal court recently overturned a jury verdict that found a doctor guilty of healthcare fraud related to billing levels for COVID-19 tests, providing defense attorneys with potential strategies for obtaining acquittals in similar prosecutions, says attorney Andrew Feldman.

• ChristianaCare Settlement Reveals FCA Pitfalls For Hospitals

  

  ChristianaCare's False Claims Act settlement in December is the first one based on a hospital allegedly providing private physicians with free services in the form of hospital-employed clinicians and provides important compliance lessons as the government ramps up scrutiny of compensation arrangements, say attorneys at Sheppard Mullin.

• Patent Waiver For COVID Meds Would Harm US Biopharma

  

  If the Biden administration backs the World Trade Organization in waiving patent rights on COVID-19 treatments, it would negatively affect the U.S. biopharmaceutical industry and help foreign competitors, without necessarily expanding global access to COVID-19 care, says clinical pathologist Wolfgang Klietmann.

• New CMS Rule Will Change Nursing Facility Disclosures

  

  A new rule from the Centers for Medicare & Medicaid Services significantly expands disclosure requirements for nursing facilities backed by private equity companies or real estate investment trusts, likely foreshadowing increased oversight that could include more targeted audits, say Janice Davis and Christopher Ronne at Morgan Lewis.

• Skirting Anti-Kickback Causation Standard Amid Circuit Split

  

  Amid the federal circuit court split over the causation standard applicable to False Claims Act cases involving Anti-Kickback Statute violations, which the First Circuit will soon consider in U.S. v. Regeneron, litigators aiming to circumvent the heightened standard should contemplate certain strategies, say Matthew Modafferi and Terence Park at Frier Levitt.

• Gilead Ruling Signals That Innovating Can Lead To Liability

  

  A California appeals court's ruling last month in Gilead Life Sciences v. Superior Court of San Francisco that a drug manufacturer can be held liable for delaying the introduction of an improved version of its medication raises concerns about the chilling effects that expansive product liability claims may have on innovation, says Gary Myers at the University of Missouri School of Law.