Policy & Compliance

Expert Analysis

• FTC's Report Criticizing Drug Middlemen Is Flawed

  

  The Federal Trade Commission's July report, which claims that pharmacy benefit managers are inflating drug costs, does not offer a credible analysis of PBMs, and its methodology lacks rigor, says Jay Ezrielev at Elevecon.

• Plan Sponsors Must Prep For New Mental Health, Drug Rules

  

  To comply with newly published health insurance rules requiring parity between access to mental health and substance use services compared to medical and surgical services, employers with self-insured plans will need to update third-party administrator agreements and collect data, among other compliance steps, say attorneys at Kilpatrick.

• A Primer On Navigating The Conrad 30 Immigration Program

  

  As the Conrad 30 program opens its annual window to help place immigrant physicians in medically underserved areas, employers and physicians engaged in the process must carefully understand the program's nuanced requirements, say Andrew Desposito and Greg Berk at Sheppard Mullin.

• Class Actions At The Circuit Courts: September Lessons

  

  In this month's review of class action appeals, Mitchell Engel at Shook Hardy identifies practice tips from four recent class certification rulings involving denial of Medicare reimbursements, automobile insurance disputes, veterans' rights and automobile defects.

• Proposed Legislation May Crack Down On Online Drug Ads

  

  A bill recently proposed in Congress could serve as a sea change in how the U.S. Food and Drug Administration regulates drug-related speech, with significant trickle-down effects on various corners of not only the drug industry but also on consumers and providers themselves, say Dominick DiSabatino and Arushi Pandya at Sheppard Mullin.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.