Expert Analysis

• How Home Infusion Providers Can Adapt To Enrollment Pause

  

  Recent Centers for Medicare & Medicaid Services moratoria on new enrollments of home health agencies, medical equipment companies and hospices make home infusion providers' compliance obligations more complex and ambiguous, requiring new careful consideration of specific enrollment requirements and limitations, say attorneys at Quarles & Brady.

• AI Data Mining Is Changing FCA Enforcement

  

  With False Claims Act investigations increasingly emerging from statistical anomalies identified by data miners, companies need to consider what conclusions an outsider armed with artificial intelligence might draw from public-facing data and be ready to explain any anomalies if questions arise, say attorneys at Cohen & Gresser.

• Lessons From 5 Months Of DOJ Corporate Policy Deals

  

  Recent declinations and prosecution agreements between the U.S. Department of Justice and corporations since the March unveiling of the corporate enforcement and voluntary disclosure policy provide takeaways for management considering how to respond to corporate misconduct, says Brendan Quigley at Baker Botts.

• Opinion

  2nd Circ. Tylenol Ruling Misapplies Daubert Gatekeeping

  

  The Second Circuit's recent ruling in Rutledge v. Walgreen Co., holding that a lower court should not have excluded experts alleging links between prenatal acetaminophen use and autism, threatens to swallow the Daubert standard by limiting courts' consideration of scientific consensus in assessing reliability of expert testimony, say attorneys at Benesch.

• 5 Antitrust Lessons On Bundled Discounts After Medtronic

  

  The recent California federal court decision upholding a $381.7 million verdict against Medtronic offers practitioners a clearer road map for navigating bundled discount claims under Section 2 of the Sherman Act, and the practical implications are substantial, say attorneys at Norton Rose.

• Justices' FTC Ruling Weakens Qui Tam's Constitutional Base

  

  The U.S. Supreme Court’s holding in Trump v. Slaughter, expanding presidential control over those exercising executive power, suggests that courts may be receptive to arguments challenging the constitutional foundations of the False Claims Act’s qui tam mechanism, says Daniel Passeser at Wiggin.

• Series

  Being A Sommelier Makes Me A Better Lawyer

  

  Being a sommelier has quietly shaped how I practice law by changing the way I think, communicate and connect with people, and offers a constant reminder that expertise is about making your knowledge useful and accessible to others, says Kara Du at Sheppard.

• Calif. Drug Ruling Affirms Defect-Centric Liability Framework

  

  The California Supreme Court's decision in Gilead Tenofovir Cases this week rejects a novel duty-to-innovate theory of negligence that could have reshaped product liability exposure well beyond the pharmaceutical industry, instead signaling that negligence claims premised on nondefective products are unlikely to succeed, say attorneys at Dechert.

• DOJ's FCA Push Creates Risks For Construction Contractors

  

  The construction industry may be uniquely vulnerable to a new generation of False Claims Act enforcement driven by the U.S. Department of Justice's increasing usage of the FCA to target a much broader category of conduct than it has in decades past, specifically compliance certifications and regulatory representations, say attorneys at Cozen O'Connor.

• Feds' Mixed Cues On Medicaid Fraud Signal States To Step Up

  

  While the federal government has recently delivered four distinct and mutually inconsistent messages regarding Medicaid fraud enforcement, states should focus on improving enforcement, regardless of which federal posture proves correct, says Ken Levine at Stone & Magnanini.

• A Shift In How Policymakers Are Approaching PBM Regulation

  

  Recent federal and state legislative and regulatory activity involving pharmacy benefit managers represent a change in focus from transparency to PBM compensation structures, vertical integration and competitive effects, say attorneys at Barclay Damon.

• Workplace Menopause Laws Demand New HR Playbooks

  

  A recent wave of state and local legislation that makes menopause an expressly protected condition in the workplace creates new compliance obligations amid an already ambiguous federal framework, and demands a workplace culture where employees feel safe asking for support, says Elliot Griffin at Ballard Spahr.

• Calif. Wiretap Ruling May Reshape Pixel Tracking Litigation

  

  The recent dismissal of a proposed class action accusing Blue Shield of California of violating the federal Wiretap Act highlights the gap between legacy wiretap laws and modern browser architecture, and the tendency of pixel tracking complaints to oversimplify or mischaracterize how browsers work, says Phil Richards at ThreatHandle Consulting.

• 11th Circ. Opioid Appeal May Shift Public Nuisance Coverage

  

  The Eleventh Circuit's recent ruling certifying to the Florida and Georgia Supreme Courts the question of whether insurers must provide coverage against suits claiming policyholders improperly distributed opioids may ultimately result in a counterbalance to the Delaware line of cases denying coverage for government opioid suits, say attorneys at Pillsbury.

• Opinion

  States Should Reconsider Forced PBM Divestiture Laws

  

  State legislatures are attempting to enact policies intended to force pharmacy benefit managers to divest from pharmacies, but these laws would have the practical effect of reducing patient access and competition, potentially violating the U.S. Constitution in the process, says former Utah Attorney General John Swallow.