Expert Analysis

• What To Expect From Calif. Bill Regulating PE In Healthcare

  

  A California bill currently awaiting Gov. Gavin Newsom's approval, intended to increase oversight over private equity and hedge fund investments in healthcare, is emblematic of recent increased scrutiny of investments in the space, and may affect transactions and operations in California in a number of ways, say attorneys at Ropes & Gray.

• SBA Proposal Materially Alters Contractor Recertification

  

  The Small Business Administration's new proposed rule on recertification affects eligibility for set-aside contracts, significantly alters the landscape for mergers and acquisitions in the government contracts industry, and could have other unintended downstream consequences, says Sam Finnerty at PilieroMazza.

• Firms Must Offer A Trifecta Of Services In Post-Chevron World

  

  After the U.S. Supreme Court’s Loper Bright Enterprises v. Raimondo decision overturning Chevron deference, law firms will need to integrate litigation, lobbying and communications functions to keep up with the ramifications of the ruling and provide adequate counsel quickly, says Neil Hare at Dentons.

• Del. Dispatch: Director Caremark Claims Need Extreme Facts

  

  The Delaware Court of Chancery recently dismissed Caremark claims against the directors of Centene in Bricklayers Pension Fund of Western Pennsylvania v. Brinkley, indicating a high bar for a finding of the required element of bad faith for Caremark liability, and stressing the need to resist hindsight bias, say attorneys at Fried Frank.

• PE Firms Should Prepare For Increased False Claims Scrutiny

  

  The impact private equity firms may have over medical decisions and care is increasingly attracting potential liability under the False Claims Act and attention from states and the federal government, so investors should follow best practices including conducting due diligence both before and after acquisitions, say attorneys at K&L Gates.

• Unpacking HHS' Opinion On Cell Therapy Refund Programs

  

  A recent advisory opinion from the U.S. Department of Health and Human Services, determining that a biopharma company's refund program for its cell therapy will not be penalized, indicates an encouraging willingness to engage, but the regulator's assumptions about the program's limited term warrant a closer look, says Mary Kohler at Kohler Health.

• How 5 States' Deal Notification Laws Are Guiding Healthcare

  

  Healthcare transaction notification laws at various stages of implementation in California, Illinois, Indiana, Oregon and Washington are shaping sector mergers and acquisitions, with significant transparency, continuity of care and compliance implications as providers tackle complex regulatory requirements, says Melesa Freerks at DLA Piper.

• The Good, The Bad And The Ugly Of Healthcare's PE Boom

  

  While an influx of capital may provide access to new resources and innovative technologies, the private equity model's method of funding may be fundamentally at odds with patient-first healthcare, and in recent years that inherent tension has gotten ugly, say Eva Gunasekera and Jaclyn Tayabji at Tycko & Zavareei.

• High Court Made Profound Mistake In Tossing Purdue Deal

  

  The U.S. Supreme Court's recent decision to throw out Purdue Pharma's Chapter 11 plan jeopardizes a multistate agreement that would provide approximately $7 billion in much-needed relief to help fight the opioid epidemic, with states now likely doomed to spend years chasing individual defendants across the globe, says Swain Wood at Morningstar.

• After Chevron: Scale Tips Favor Away From HHS Agencies

  

  The loss of Chevron deference may indirectly aid parties in challenging the U.S. Department of Health and Human Services' interpretations of regulations and could immediately influence several pending cases challenging HHS on technical questions and agency authority, say attorneys at Ropes & Gray.

• After Chevron: FDA Regulations In The Crosshairs

  

  The U.S. Supreme Court's overturning of the Chevron doctrine is likely to unleash an array of challenges against the U.S. Food and Drug Administration, focusing on areas of potential overreach such as the FDA's authority under the Federal Food, Drug and Cosmetic Act, say attorneys at Debevoise.

• Navigating Scrutiny Of Friendly Professional Corps. In Calif.

  

  In light of ongoing scrutiny and challenges to private equity participation in the California healthcare marketplace, particularly surrounding the use of the friendly professional corporation model, management services organizations should consider implementing four best practices, say attorneys at Holland & Knight.

• Class Actions At The Circuit Courts: June Lessons

  

  In this month's review of class action appeals, Mitchell Engel at Shook Hardy considers two recent decisions from the Third and Tenth Circuits, and identifies practice tips around class action settlements and standing in securities litigation.