Deals & Corporate Governance

Expert Analysis

• 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.

• The Current State Of Healthcare Transaction Reviews In Calif.

  

  As of April, certain healthcare transactions in California have been subject to additional notification compliance requirements, and complying with these new rules could significantly delay and discourage some deals, says Andrew Demetriou at Husch Blackwell.

• Careful Data Governance Is A Must Amid Enforcement Focus

  

  Federal and state regulators' heightened focus on privacy enforcement, including the Federal Trade Commission's recent guidance on consumer protection in the car industry, highlight the importance of proactive risk management, compliance and data governance, say Jason Priebe and Danny Riley at Seyfarth.

• 5 Steps To Navigating State Laws On Healthcare Transactions

  

  As more states pass legislation requiring healthcare-transaction notice, private equity investors and other deal parties should evaluate the new laws and consider ways to mitigate their effects, say Carol Loepere and Nicole Aiken-Shaban at Reed Smith.

• Feds' Biotech Enforcement Efforts Are Too Heavy-Handed

  

  The U.S. Department of Justice's recent actions against biotech companies untether the Anti-Kickback Statute from its original legislative purpose, and threaten to stifle innovation and undermine patient quality of care, say attorneys at Ropes & Gray.

• Del. Ruling Highlights M&A Deal Adviser Conflict Disclosures

  

  The Delaware Supreme Court recently reversed the Court of Chancery's dismissal of challenges to Nordic Capital's acquisition of Inovalon, demonstrating the importance of full disclosure of financial adviser conflicts when a going-private merger seeks business judgment rule review, say attorneys at Debevoise.