Expert Analysis

• Vertex Suit Highlights Issues For Pharma Fertility Support

  

  Vertex Pharmaceuticals' recent lawsuit challenging the U.S. Department of Health and Human Services' interpretation of the Anti-Kickback Statute is influenced by a number of reproductive rights and health equity issues that the Office of Inspector General should address more concretely, including in vitro fertilization and fertility preservation programs, says Mary Kohler at Kohler Health Law.

• Opinion

  CMS' New 'Breakthrough' Device Policy Shows Little Promise

  

  The Centers for Medicare & Medicaid Services’ recent procedural notice outlining a new Medicare coverage pathway for breakthrough medical devices will, at best, be a failed experiment and, at worst, result in Medicare beneficiaries denied access to innovative treatments, say attorneys at King & Spalding.

• Assessing Algorithmic Versus Generative AI Pricing Tools

  

  A comparison of traditional algorithmic pricing models and those powered by generative artificial intelligence can help regulators and practitioners weigh the pros and cons of relying on large language models to price products or services, say Maxime Cohen at McGill University, and Tim Spittle and Jimmy Royer at Analysis Group.

• 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.

• A Preview Of AI Priorities Under The Next President

  

  For the first time in a presidential election, both of the leading candidates and their parties have been vocal about artificial intelligence policy, offering clues on the future of regulation as AI continues to advance and congressional action continues to stall, say attorneys at Mintz.

• How Companies Are Approaching Insider Trading Policies

  

  An analysis of insider trading policies recently disclosed by 49 S&P 500 companies under a new U.S. Securities and Exchange Commission rule reveals that while specific provisions vary from company to company, certain common themes are emerging, say attorneys at Gibson Dunn.

• 11 Patent Cases To Watch At Fed. Circ. And High Court

  

  As we head into fall, there are 11 patent cases to monitor, touching on a range of issues that could affect patent strategy, such as biotech innovation, administrative rulemaking and patent eligibility, say Edward Lanquist and Wesley Barbee at Baker Donelson.

• Managing Community Health Needs Assessments: A Checklist

  Excerpt from Practical Guidance

  

  To guide nonprofit hospitals and health systems through their required community health needs assessment every three years, this checklist outlines the steps for 12 phases of the process.

• How Methods Are Evolving In Textualist Interpretations

  

  Textualists at the U.S. Supreme Court are increasingly considering new methods such as corpus linguistics and surveys to evaluate what a statute's text communicates to an ordinary reader, while lower courts even mull large language models like ChatGPT as supplements, says Kevin Tobia at Georgetown Law.

• 7th Circ. Rulings Offer Employee Vaccine Exemption Guidance

  

  Dawn Solowey and Samantha Brooks at Seyfarth explain how two recent Seventh Circuit rulings in Passarella v. Aspirus and Bube v. Aspirus could affect litigation involving employee vaccine exemptions, and discuss employer best practices for handling accommodation requests that include both religious and secular concerns.

• Pa. Health Employers Must Prep For Noncompete Restrictions

  

  Newly enacted legislation in Pennsylvania prohibits certain noncompete covenants for healthcare practitioners in the state beginning next year, creating compliance challenges that both employers and employees should be aware of, say attorneys at Buchanan Ingersoll.

• Opinion

  Congress Must Do More To Bolster ERISA Protections

  

  As the Employee Retirement Income Security Act turns 50 this month, we applaud Congress for championing a statute that protects worker and retiree rights, but further action is needed to ban arbitration clauses in plan provisions and codify regulations imperiled by the U.S. Supreme Court’s Chevron ruling, say Michelle Yau and Eleanor Frisch at Cohen Milstein.

• FTC Focus: What Access To Patent Settlements Would Mean

  

  Settling parties should adopt a series of practice tips, including specifying rationales to support specific terms, as the Federal Trade Commission seeks to expand its access to settlements before the Patent Trial and Appeal Board, say Shannon McGowan and David Munkittrick at Proskauer.

• Why Attorneys Should Consider Community Leadership Roles

  

  Volunteering and nonprofit board service are complementary to, but distinct from, traditional pro bono work, and taking on these community leadership roles can produce dividends for lawyers, their firms and the nonprofit causes they support, says Katie Beacham at Kilpatrick.

• Opinion

  Agencies Should Reward Corporate Cyber Victim Cooperation

  

  The increased regulatory scrutiny on corporate victims of cyberattacks — exemplified by the U.S. Securities and Exchange Commission's case against SolarWinds — should be replaced with a new model that provides adequate incentives for companies to come forward proactively and collaborate with law enforcement, say attorneys at McDermott.